Antivirals, pain relief, rest are key to zoster management

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Antivirals, pain relief, rest are key to zoster management

WASHINGTON – Antivirals, rest, and pain management are the Big Three of shingles treatment, and they should be employed early and consistently.

There are ways to tweak response, such as augmenting pain management with antidepressants or anticonvulsants. And a corticosteroid may have a place in the mix for some patients. But the importance of the Big Three can’t be overstressed, Dr. Kenneth Tomecki said at the annual meeting of the American Academy of Dermatology.

“You want to halt the progression of disease and decrease viral shedding,” said Dr. Tomecki of the Cleveland Clinic in Ohio. “But the key to successful treatment is to decrease the severity of pain. It is a strong attendant feature. There will be pain and we need to try hard to keep it as brief as possible. Some patients are stoic and will tell you they don’t need anything for pain. Don’t believe them.”

Dr. Kenneth Tomecki
Dr. Kenneth Tomecki

Managing pain also makes it easier to get patients to relax and slow down. “Rest, rest, rest, and more rest. Rest leads the list. These patients need to slow down and cool it. They have a viral illness and systemic disease. Rest is mandatory.”

Antiviral therapy is a key part of treatment, but only if it’s timely. “If you can get it on board in the first 72 hours, you can increase the likelihood of the rash resolving quickly, limit the pain, and reduce the risk of postherpetic neuralgia by 50%.”

The mainstay of antiviral therapy has been acyclovir, which is effective and inexpensive – about $30 for a 7-10 day course. But its bioavailability is not great, which means patients need to take it five times a day.

Famciclovir and valacyclovir possess more efficient pharmacokinetic profiles, and are just as safe and well-tolerated. Their thrice-daily dosing schedules make them a little more manageable for most patients. They are more expensive (about $100 for a week-long course), but not prohibitively so, Dr. Tomecki said. And both of them are effective, with evidence from a randomized, double-blind, controlled trial showing a similar benefit for acute pain and postherpetic neuralgia (Arch Fam Med. 2000;9:863-9).

“I would say both of the newer drugs work a little bit better than acyclovir, but they are similar to each other,” he said. “My go-to treatment for uncomplicated zoster is 1 gram of valacyclovir three times a day for 7-10 days, and I throw in either gabapentin or pregabalin.”

In an open-label study of 166 patients (Arch Dermatol. 2011;147[8]:901-7), this combination resulted in less than a 10% incidence of postherpetic neuralgia at 6 months, Dr. Tomecki added.

Mild pain during the acute phase can be handled with acetaminophen or nonsteroidal anti-inflammatories. But lots of patients need a bigger bullet for their discomfort. Tramadol at 50 mg/day or a weak opioid will work for moderate pain. With severe pain, start thinking about oxycodone.

A tapered dose of corticosteroid can be included, especially if cellulitis is involved in the clinical picture. “It does help patients feel better, and there’s no real detriment to it,” Dr. Tomecki said.

Patients who have postherpetic pain may need longer-term pain management. Lidocaine patches and capsaicin cream are both effective, and they work best if used consistently. The recommended dosing frequency for capsaicin is three or four times a day, “But to be really effective I find you need to apply it more like five or six times a day.”

Patients with persistent postherpetic pain should probably be referred to a neurologist or pain management specialist. In the meantime, though, tricyclic antidepressants aren’t out of the question, but they take a while to kick in and must be used very, very carefully in elderly patients. “Don’t jump in initially with these. Start with good derm care and rest.”

The anticonvulsants gabapentin or pregabalin can also be helpful. “If you do start any of these, start low, go slow and refer for pain management.”

A 2014 meta-analysis of seven studies, however, showed a mixed bag of benefits and tradeoffs (Minerva Anestesiol. 2014 May;80[5]:556-67). Gabapentin improved sleep quality and significantly reduce pain, but patients who took it were likely to report dizziness, sleepiness, edema, ataxia, and diarrhea.

Antidepressants and anticonvulsants may be out of the purview of many dermatologists, but other pain management strategies are not, Dr. Tomecki said. Among them is cryotherapy.

“I’m not talking about freezing as in truly freezing like with do with actinic keratosis. I’m talking about just a gentle brushing of the area.”

A small study of 47 patients employed a 30-second pass of liquid nitrogen over the affected sensory nerve dermatome, making sure not to freeze the skin (Int J Dermatol. 2011 Jun;50[6]:746-50). The treatment consisted of three passes per session on a weekly basis. Most of the patients (94%) experienced good or excellent improvements by week 6. For 19%, one session was enough to eliminate pain, and 17% had complete pain relief in two sessions.

 

 

Narrow-band ultraviolet light is another easy and inexpensive option, Dr. Tomecki said. ”We only have a small study on this, but more than 50% of patients in it did very well.”

The 17 patients had three weekly sessions of light therapy for 15 weeks or until pain disappeared. About half reported at least a 50% improvement in pain by the end of 3 months (Indian J Dermatol. 2011 Jan-Feb;56[1]:44–47).

“These are both interventions that are easily available, inexpensive, and well within our reach as dermatologists,” he said.

He had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

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WASHINGTON – Antivirals, rest, and pain management are the Big Three of shingles treatment, and they should be employed early and consistently.

There are ways to tweak response, such as augmenting pain management with antidepressants or anticonvulsants. And a corticosteroid may have a place in the mix for some patients. But the importance of the Big Three can’t be overstressed, Dr. Kenneth Tomecki said at the annual meeting of the American Academy of Dermatology.

“You want to halt the progression of disease and decrease viral shedding,” said Dr. Tomecki of the Cleveland Clinic in Ohio. “But the key to successful treatment is to decrease the severity of pain. It is a strong attendant feature. There will be pain and we need to try hard to keep it as brief as possible. Some patients are stoic and will tell you they don’t need anything for pain. Don’t believe them.”

Dr. Kenneth Tomecki
Dr. Kenneth Tomecki

Managing pain also makes it easier to get patients to relax and slow down. “Rest, rest, rest, and more rest. Rest leads the list. These patients need to slow down and cool it. They have a viral illness and systemic disease. Rest is mandatory.”

Antiviral therapy is a key part of treatment, but only if it’s timely. “If you can get it on board in the first 72 hours, you can increase the likelihood of the rash resolving quickly, limit the pain, and reduce the risk of postherpetic neuralgia by 50%.”

The mainstay of antiviral therapy has been acyclovir, which is effective and inexpensive – about $30 for a 7-10 day course. But its bioavailability is not great, which means patients need to take it five times a day.

Famciclovir and valacyclovir possess more efficient pharmacokinetic profiles, and are just as safe and well-tolerated. Their thrice-daily dosing schedules make them a little more manageable for most patients. They are more expensive (about $100 for a week-long course), but not prohibitively so, Dr. Tomecki said. And both of them are effective, with evidence from a randomized, double-blind, controlled trial showing a similar benefit for acute pain and postherpetic neuralgia (Arch Fam Med. 2000;9:863-9).

“I would say both of the newer drugs work a little bit better than acyclovir, but they are similar to each other,” he said. “My go-to treatment for uncomplicated zoster is 1 gram of valacyclovir three times a day for 7-10 days, and I throw in either gabapentin or pregabalin.”

In an open-label study of 166 patients (Arch Dermatol. 2011;147[8]:901-7), this combination resulted in less than a 10% incidence of postherpetic neuralgia at 6 months, Dr. Tomecki added.

Mild pain during the acute phase can be handled with acetaminophen or nonsteroidal anti-inflammatories. But lots of patients need a bigger bullet for their discomfort. Tramadol at 50 mg/day or a weak opioid will work for moderate pain. With severe pain, start thinking about oxycodone.

A tapered dose of corticosteroid can be included, especially if cellulitis is involved in the clinical picture. “It does help patients feel better, and there’s no real detriment to it,” Dr. Tomecki said.

Patients who have postherpetic pain may need longer-term pain management. Lidocaine patches and capsaicin cream are both effective, and they work best if used consistently. The recommended dosing frequency for capsaicin is three or four times a day, “But to be really effective I find you need to apply it more like five or six times a day.”

Patients with persistent postherpetic pain should probably be referred to a neurologist or pain management specialist. In the meantime, though, tricyclic antidepressants aren’t out of the question, but they take a while to kick in and must be used very, very carefully in elderly patients. “Don’t jump in initially with these. Start with good derm care and rest.”

The anticonvulsants gabapentin or pregabalin can also be helpful. “If you do start any of these, start low, go slow and refer for pain management.”

A 2014 meta-analysis of seven studies, however, showed a mixed bag of benefits and tradeoffs (Minerva Anestesiol. 2014 May;80[5]:556-67). Gabapentin improved sleep quality and significantly reduce pain, but patients who took it were likely to report dizziness, sleepiness, edema, ataxia, and diarrhea.

Antidepressants and anticonvulsants may be out of the purview of many dermatologists, but other pain management strategies are not, Dr. Tomecki said. Among them is cryotherapy.

“I’m not talking about freezing as in truly freezing like with do with actinic keratosis. I’m talking about just a gentle brushing of the area.”

A small study of 47 patients employed a 30-second pass of liquid nitrogen over the affected sensory nerve dermatome, making sure not to freeze the skin (Int J Dermatol. 2011 Jun;50[6]:746-50). The treatment consisted of three passes per session on a weekly basis. Most of the patients (94%) experienced good or excellent improvements by week 6. For 19%, one session was enough to eliminate pain, and 17% had complete pain relief in two sessions.

 

 

Narrow-band ultraviolet light is another easy and inexpensive option, Dr. Tomecki said. ”We only have a small study on this, but more than 50% of patients in it did very well.”

The 17 patients had three weekly sessions of light therapy for 15 weeks or until pain disappeared. About half reported at least a 50% improvement in pain by the end of 3 months (Indian J Dermatol. 2011 Jan-Feb;56[1]:44–47).

“These are both interventions that are easily available, inexpensive, and well within our reach as dermatologists,” he said.

He had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

WASHINGTON – Antivirals, rest, and pain management are the Big Three of shingles treatment, and they should be employed early and consistently.

There are ways to tweak response, such as augmenting pain management with antidepressants or anticonvulsants. And a corticosteroid may have a place in the mix for some patients. But the importance of the Big Three can’t be overstressed, Dr. Kenneth Tomecki said at the annual meeting of the American Academy of Dermatology.

“You want to halt the progression of disease and decrease viral shedding,” said Dr. Tomecki of the Cleveland Clinic in Ohio. “But the key to successful treatment is to decrease the severity of pain. It is a strong attendant feature. There will be pain and we need to try hard to keep it as brief as possible. Some patients are stoic and will tell you they don’t need anything for pain. Don’t believe them.”

Dr. Kenneth Tomecki
Dr. Kenneth Tomecki

Managing pain also makes it easier to get patients to relax and slow down. “Rest, rest, rest, and more rest. Rest leads the list. These patients need to slow down and cool it. They have a viral illness and systemic disease. Rest is mandatory.”

Antiviral therapy is a key part of treatment, but only if it’s timely. “If you can get it on board in the first 72 hours, you can increase the likelihood of the rash resolving quickly, limit the pain, and reduce the risk of postherpetic neuralgia by 50%.”

The mainstay of antiviral therapy has been acyclovir, which is effective and inexpensive – about $30 for a 7-10 day course. But its bioavailability is not great, which means patients need to take it five times a day.

Famciclovir and valacyclovir possess more efficient pharmacokinetic profiles, and are just as safe and well-tolerated. Their thrice-daily dosing schedules make them a little more manageable for most patients. They are more expensive (about $100 for a week-long course), but not prohibitively so, Dr. Tomecki said. And both of them are effective, with evidence from a randomized, double-blind, controlled trial showing a similar benefit for acute pain and postherpetic neuralgia (Arch Fam Med. 2000;9:863-9).

“I would say both of the newer drugs work a little bit better than acyclovir, but they are similar to each other,” he said. “My go-to treatment for uncomplicated zoster is 1 gram of valacyclovir three times a day for 7-10 days, and I throw in either gabapentin or pregabalin.”

In an open-label study of 166 patients (Arch Dermatol. 2011;147[8]:901-7), this combination resulted in less than a 10% incidence of postherpetic neuralgia at 6 months, Dr. Tomecki added.

Mild pain during the acute phase can be handled with acetaminophen or nonsteroidal anti-inflammatories. But lots of patients need a bigger bullet for their discomfort. Tramadol at 50 mg/day or a weak opioid will work for moderate pain. With severe pain, start thinking about oxycodone.

A tapered dose of corticosteroid can be included, especially if cellulitis is involved in the clinical picture. “It does help patients feel better, and there’s no real detriment to it,” Dr. Tomecki said.

Patients who have postherpetic pain may need longer-term pain management. Lidocaine patches and capsaicin cream are both effective, and they work best if used consistently. The recommended dosing frequency for capsaicin is three or four times a day, “But to be really effective I find you need to apply it more like five or six times a day.”

Patients with persistent postherpetic pain should probably be referred to a neurologist or pain management specialist. In the meantime, though, tricyclic antidepressants aren’t out of the question, but they take a while to kick in and must be used very, very carefully in elderly patients. “Don’t jump in initially with these. Start with good derm care and rest.”

The anticonvulsants gabapentin or pregabalin can also be helpful. “If you do start any of these, start low, go slow and refer for pain management.”

A 2014 meta-analysis of seven studies, however, showed a mixed bag of benefits and tradeoffs (Minerva Anestesiol. 2014 May;80[5]:556-67). Gabapentin improved sleep quality and significantly reduce pain, but patients who took it were likely to report dizziness, sleepiness, edema, ataxia, and diarrhea.

Antidepressants and anticonvulsants may be out of the purview of many dermatologists, but other pain management strategies are not, Dr. Tomecki said. Among them is cryotherapy.

“I’m not talking about freezing as in truly freezing like with do with actinic keratosis. I’m talking about just a gentle brushing of the area.”

A small study of 47 patients employed a 30-second pass of liquid nitrogen over the affected sensory nerve dermatome, making sure not to freeze the skin (Int J Dermatol. 2011 Jun;50[6]:746-50). The treatment consisted of three passes per session on a weekly basis. Most of the patients (94%) experienced good or excellent improvements by week 6. For 19%, one session was enough to eliminate pain, and 17% had complete pain relief in two sessions.

 

 

Narrow-band ultraviolet light is another easy and inexpensive option, Dr. Tomecki said. ”We only have a small study on this, but more than 50% of patients in it did very well.”

The 17 patients had three weekly sessions of light therapy for 15 weeks or until pain disappeared. About half reported at least a 50% improvement in pain by the end of 3 months (Indian J Dermatol. 2011 Jan-Feb;56[1]:44–47).

“These are both interventions that are easily available, inexpensive, and well within our reach as dermatologists,” he said.

He had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

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Nemolizumab Improved Most Common Symptoms in Moderate, Severe Atopic Dermatitis

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Nemolizumab Improved Most Common Symptoms in Moderate, Severe Atopic Dermatitis

WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.

“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”

Dr. Jon M. Hanifin
jancin
Dr. Jon M. Hanifin

Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.

The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.

The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.

Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).

The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.

Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.

Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.

CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.

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WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.

“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”

Dr. Jon M. Hanifin
jancin
Dr. Jon M. Hanifin

Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.

The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.

The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.

Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).

The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.

Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.

Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.

CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.

WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.

“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”

Dr. Jon M. Hanifin
jancin
Dr. Jon M. Hanifin

Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.

The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.

The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.

Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).

The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.

Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.

Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.

CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.

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Nemolizumab improved most common symptoms in moderate, severe atopic dermatitis

Article Type
Changed
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Display Headline
Nemolizumab improved most common symptoms in moderate, severe atopic dermatitis

WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.

“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”

Dr. Jon M. Hanifin
jancin
Dr. Jon M. Hanifin

Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.

The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.

The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.

Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).

The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.

Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.

Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.

CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.

“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”

Dr. Jon M. Hanifin
jancin
Dr. Jon M. Hanifin

Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.

The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.

The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.

Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).

The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.

Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.

Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.

CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.

“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”

Dr. Jon M. Hanifin
jancin
Dr. Jon M. Hanifin

Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.

The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.

The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.

Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).

The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.

Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.

Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.

CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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Key clinical point: Nemolizumab rapidly and consistently improved pruritus, dermatitis and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis.

Major finding: At week 12, patients treated with nemolizumab reported reductions in pruritus of −41.5% for 0.1 mg/kg, −61.2% for 0.5 mg/kg, and −60.5% 2.0 mg/kg vs. −20.1% for placebo (P less than .01 for all).

Data source: Randomized, double-blind, placebo-controlled, multi-center, multi-dose phase II study of 264 patients with moderate-to-severe atopic dermatitis.

Disclosures: This trial was sponsored by Chugai Pharmaceuticals.

60 weeks of ixekizumab effective, well tolerated in moderate-to-severe plaque psoriasis

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WASHINGTON – After 60 weeks of continuous therapy with the investigational drug ixekizumab, 722 patients who initially had moderate to severe plaque psoriasis had Psoriasis Area Severity Index (PASI) 75, 90, and 100 response rates of 87%, 78%, and 57%, respectively, based on study results presented by Dr. Andrew Blauvelt at the annual meeting of the American Academy of Dermatology.

Additionally, the rate of complete clearance or mild severity of plaque psoriasis based on the Physician Global Assessment measure was 79% in the study patients. Dr. Blauvelt said “these were tremendous results over time.”

Dr. Andrew Blauvelt
Dr. Andrew Blauvelt

The findings come from the open-label continuation study of ixekizumab in UNCOVER-3. At week 12 of that study, 722 ixekizumab-treated patients were continued on or converted to a regimen of 80 mg ixekizumab every 4 weeks.

In UNCOVER-3, all study participants initially received induction therapy with ixekizumab and then were randomized to placebo (193 patients), etanercept 50 mg twice weekly (382 patients), 80 mg ixekizumab every 4 weeks (386 patients) after a 160 mg starting dose, or 80 mg ixekizumab every 2 weeks (385 patients) after an initial 160 mg starting dose. After 12 weeks, patients entered open-label treatment with the study drug once every 4 weeks.

The long-term safety and tolerability profile was similar to the one seen during the induction period and cited in previously published data. Dr. Blauvelt, President of the Oregon Medical Research Center, said the finding was “good news, in that there were no unexpected safety signals [not already] seen with initial therapy.”

Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokines, inhibiting interaction with the IL-17 receptor.

According to a spokesperson from Eli Lilly, sponsor of the UNCOVER trial and maker of ixekizumab, a decision from the U.S. Food and Drug Administration on whether to approve ixekizumab for use in psoriasis is expected during the first quarter of 2016.

Dr. Blauvelt is an advisor or consultant for and has received research grants from a wide variety of drug companies including Eli Lilly.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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WASHINGTON – After 60 weeks of continuous therapy with the investigational drug ixekizumab, 722 patients who initially had moderate to severe plaque psoriasis had Psoriasis Area Severity Index (PASI) 75, 90, and 100 response rates of 87%, 78%, and 57%, respectively, based on study results presented by Dr. Andrew Blauvelt at the annual meeting of the American Academy of Dermatology.

Additionally, the rate of complete clearance or mild severity of plaque psoriasis based on the Physician Global Assessment measure was 79% in the study patients. Dr. Blauvelt said “these were tremendous results over time.”

Dr. Andrew Blauvelt
Dr. Andrew Blauvelt

The findings come from the open-label continuation study of ixekizumab in UNCOVER-3. At week 12 of that study, 722 ixekizumab-treated patients were continued on or converted to a regimen of 80 mg ixekizumab every 4 weeks.

In UNCOVER-3, all study participants initially received induction therapy with ixekizumab and then were randomized to placebo (193 patients), etanercept 50 mg twice weekly (382 patients), 80 mg ixekizumab every 4 weeks (386 patients) after a 160 mg starting dose, or 80 mg ixekizumab every 2 weeks (385 patients) after an initial 160 mg starting dose. After 12 weeks, patients entered open-label treatment with the study drug once every 4 weeks.

The long-term safety and tolerability profile was similar to the one seen during the induction period and cited in previously published data. Dr. Blauvelt, President of the Oregon Medical Research Center, said the finding was “good news, in that there were no unexpected safety signals [not already] seen with initial therapy.”

Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokines, inhibiting interaction with the IL-17 receptor.

According to a spokesperson from Eli Lilly, sponsor of the UNCOVER trial and maker of ixekizumab, a decision from the U.S. Food and Drug Administration on whether to approve ixekizumab for use in psoriasis is expected during the first quarter of 2016.

Dr. Blauvelt is an advisor or consultant for and has received research grants from a wide variety of drug companies including Eli Lilly.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

WASHINGTON – After 60 weeks of continuous therapy with the investigational drug ixekizumab, 722 patients who initially had moderate to severe plaque psoriasis had Psoriasis Area Severity Index (PASI) 75, 90, and 100 response rates of 87%, 78%, and 57%, respectively, based on study results presented by Dr. Andrew Blauvelt at the annual meeting of the American Academy of Dermatology.

Additionally, the rate of complete clearance or mild severity of plaque psoriasis based on the Physician Global Assessment measure was 79% in the study patients. Dr. Blauvelt said “these were tremendous results over time.”

Dr. Andrew Blauvelt
Dr. Andrew Blauvelt

The findings come from the open-label continuation study of ixekizumab in UNCOVER-3. At week 12 of that study, 722 ixekizumab-treated patients were continued on or converted to a regimen of 80 mg ixekizumab every 4 weeks.

In UNCOVER-3, all study participants initially received induction therapy with ixekizumab and then were randomized to placebo (193 patients), etanercept 50 mg twice weekly (382 patients), 80 mg ixekizumab every 4 weeks (386 patients) after a 160 mg starting dose, or 80 mg ixekizumab every 2 weeks (385 patients) after an initial 160 mg starting dose. After 12 weeks, patients entered open-label treatment with the study drug once every 4 weeks.

The long-term safety and tolerability profile was similar to the one seen during the induction period and cited in previously published data. Dr. Blauvelt, President of the Oregon Medical Research Center, said the finding was “good news, in that there were no unexpected safety signals [not already] seen with initial therapy.”

Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokines, inhibiting interaction with the IL-17 receptor.

According to a spokesperson from Eli Lilly, sponsor of the UNCOVER trial and maker of ixekizumab, a decision from the U.S. Food and Drug Administration on whether to approve ixekizumab for use in psoriasis is expected during the first quarter of 2016.

Dr. Blauvelt is an advisor or consultant for and has received research grants from a wide variety of drug companies including Eli Lilly.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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Key clinical point: Continuous therapy with the investigational drug ixekizumab appears to be safe and effective for long-term use.

Major finding: At Week 60, the PASI 75, 90, and 100 response rates were 87%, 78%, and 57%, respectively.

Data source: Phase 3 UNCOVER-3 trial of 1,346 patients randomized to placebo, active control, or ixekizumab at every 4 weeks or every 2 weeks after induction.

Disclosures: This trial was sponsored by Eli Lilly, maker of ixekizumab. Dr. Blauvelt is an advisor or consultant for and has received research grants from a wide variety of drug companies including Eli Lilly.

AAD: Transgender patients: Isotretinoin regs can be a challenge

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WASHINGTON – Enrolling a transgender man in the iPLEDGE pregnancy prevention program is among the issues dermatologists can face when caring for transgender patients, Dr. Brian Ginsberg said at the annual meeting of the American Academy of Dermatology.*

iPLEDGE requirements are based on an individual’s gender, not only on their potential childbearing potential, “making it a challenge to appropriately classify our transgender patients,” said Dr. Ginsberg, a dermatologist in private practice in New York. Enrolling a transgender man who is experiencing severe acne vulgaris as a result of hormone therapy is one of the hurdles in caring for this patient population, he added.

Dr. Ginsberg provided advice on how to manage adverse effects of hormone therapy on skin and hair, and other dermatologic issues that transgender individuals may experience. Because there is not much information on this topic in the medical literature, he pointed out that his recommendations are based largely on personal and anecdotal experiences.

Transgender men taking testosterone experience significant increases in sebum production, and there are many reports of transgender men with severe acne vulgaris, he noted.

Transgender men may still be of childbearing potential, even if they are on testosterone, and he typically keeps his transgender male patients classified as females of childbearing potential, for the sake of iPLEDGE, and has “a very important and honest conversation with them” about having to register as females.

“It’s unfortunate that for now, we have to have that conversation,” but it must be done, he added.

A member of the audience said he has a transgender male patient who is preparing for reduction mammoplasty, is on testosterone, has severe acne, and was previously registered in the iPLEDGE program as a female. “So what’s my next step?” he asked.

Dr. Ginsberg said he has had patients in the same situation, and after having an honest conversation with the patient, “we realized the priority was getting the patient on isotretinoin and the patient was comfortable in maintaining the registration as a female of childbearing potential.”

This is not an issue for female transgender patients, who do not have a uterus and are not of childbearing potential. These patients are, however, at an increased risk of hormone-associated dermatoses.

“Transgender women taking estrogens experience rapid and prolonged low sebum production, resulting in xerosis and asteatotic eczema,” he said.

Another issue is when to prescribe finasteride for transgender men on testosterone who experience male pattern hair loss. He advised avoiding finasteride until body hair and other desired secondary sex characteristics are fully developed, which could be up to 2 years, Dr. Ginsberg said.

To make transgender patients more comfortable in the office, Dr. Ginsberg recommended the following:

• Modify intake forms. Allow for patients to write in their gender, instead of offering the option of male or female.

• Respect the use of correct pronouns. “If you have a transgender woman sitting in front of you, don’t refer to her as him,” he commented. Consider asking the patient which pronoun is preferred.

• Make no assumptions. “Gender identity has nothing to do with sexual orientation,” he said. “A person’s gender is however they self-identify, period.” It has nothing to do with clothing, hormones, surgery “or any other aspect of transitioning,” he explained. “If a patient sitting in front of you says that they are a man, it doesn’t matter what they look like or what they’ve had done, that person is a man.”

• Be comfortable about being uncomfortable. “The community is coming to understand that we don’t know everything. … and we may have questions, we may not understand the details of the surgery or medications that they’re on. So rather than ignore the issue altogether, ask them about it,” Dr. Ginsberg said. “They will be more excited that you care … and want to help, rather than ignore the issue altogether.” Dr. Ginsberg reported no relevant disclosures.

emechcatie@frontlinemedcom.com

This article was updated March 8, 2016.

*Correction, 03/15/2016: An earlier version of this article misstated Dr. Brian Ginsberg's name. 

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WASHINGTON – Enrolling a transgender man in the iPLEDGE pregnancy prevention program is among the issues dermatologists can face when caring for transgender patients, Dr. Brian Ginsberg said at the annual meeting of the American Academy of Dermatology.*

iPLEDGE requirements are based on an individual’s gender, not only on their potential childbearing potential, “making it a challenge to appropriately classify our transgender patients,” said Dr. Ginsberg, a dermatologist in private practice in New York. Enrolling a transgender man who is experiencing severe acne vulgaris as a result of hormone therapy is one of the hurdles in caring for this patient population, he added.

Dr. Ginsberg provided advice on how to manage adverse effects of hormone therapy on skin and hair, and other dermatologic issues that transgender individuals may experience. Because there is not much information on this topic in the medical literature, he pointed out that his recommendations are based largely on personal and anecdotal experiences.

Transgender men taking testosterone experience significant increases in sebum production, and there are many reports of transgender men with severe acne vulgaris, he noted.

Transgender men may still be of childbearing potential, even if they are on testosterone, and he typically keeps his transgender male patients classified as females of childbearing potential, for the sake of iPLEDGE, and has “a very important and honest conversation with them” about having to register as females.

“It’s unfortunate that for now, we have to have that conversation,” but it must be done, he added.

A member of the audience said he has a transgender male patient who is preparing for reduction mammoplasty, is on testosterone, has severe acne, and was previously registered in the iPLEDGE program as a female. “So what’s my next step?” he asked.

Dr. Ginsberg said he has had patients in the same situation, and after having an honest conversation with the patient, “we realized the priority was getting the patient on isotretinoin and the patient was comfortable in maintaining the registration as a female of childbearing potential.”

This is not an issue for female transgender patients, who do not have a uterus and are not of childbearing potential. These patients are, however, at an increased risk of hormone-associated dermatoses.

“Transgender women taking estrogens experience rapid and prolonged low sebum production, resulting in xerosis and asteatotic eczema,” he said.

Another issue is when to prescribe finasteride for transgender men on testosterone who experience male pattern hair loss. He advised avoiding finasteride until body hair and other desired secondary sex characteristics are fully developed, which could be up to 2 years, Dr. Ginsberg said.

To make transgender patients more comfortable in the office, Dr. Ginsberg recommended the following:

• Modify intake forms. Allow for patients to write in their gender, instead of offering the option of male or female.

• Respect the use of correct pronouns. “If you have a transgender woman sitting in front of you, don’t refer to her as him,” he commented. Consider asking the patient which pronoun is preferred.

• Make no assumptions. “Gender identity has nothing to do with sexual orientation,” he said. “A person’s gender is however they self-identify, period.” It has nothing to do with clothing, hormones, surgery “or any other aspect of transitioning,” he explained. “If a patient sitting in front of you says that they are a man, it doesn’t matter what they look like or what they’ve had done, that person is a man.”

• Be comfortable about being uncomfortable. “The community is coming to understand that we don’t know everything. … and we may have questions, we may not understand the details of the surgery or medications that they’re on. So rather than ignore the issue altogether, ask them about it,” Dr. Ginsberg said. “They will be more excited that you care … and want to help, rather than ignore the issue altogether.” Dr. Ginsberg reported no relevant disclosures.

emechcatie@frontlinemedcom.com

This article was updated March 8, 2016.

*Correction, 03/15/2016: An earlier version of this article misstated Dr. Brian Ginsberg's name. 

WASHINGTON – Enrolling a transgender man in the iPLEDGE pregnancy prevention program is among the issues dermatologists can face when caring for transgender patients, Dr. Brian Ginsberg said at the annual meeting of the American Academy of Dermatology.*

iPLEDGE requirements are based on an individual’s gender, not only on their potential childbearing potential, “making it a challenge to appropriately classify our transgender patients,” said Dr. Ginsberg, a dermatologist in private practice in New York. Enrolling a transgender man who is experiencing severe acne vulgaris as a result of hormone therapy is one of the hurdles in caring for this patient population, he added.

Dr. Ginsberg provided advice on how to manage adverse effects of hormone therapy on skin and hair, and other dermatologic issues that transgender individuals may experience. Because there is not much information on this topic in the medical literature, he pointed out that his recommendations are based largely on personal and anecdotal experiences.

Transgender men taking testosterone experience significant increases in sebum production, and there are many reports of transgender men with severe acne vulgaris, he noted.

Transgender men may still be of childbearing potential, even if they are on testosterone, and he typically keeps his transgender male patients classified as females of childbearing potential, for the sake of iPLEDGE, and has “a very important and honest conversation with them” about having to register as females.

“It’s unfortunate that for now, we have to have that conversation,” but it must be done, he added.

A member of the audience said he has a transgender male patient who is preparing for reduction mammoplasty, is on testosterone, has severe acne, and was previously registered in the iPLEDGE program as a female. “So what’s my next step?” he asked.

Dr. Ginsberg said he has had patients in the same situation, and after having an honest conversation with the patient, “we realized the priority was getting the patient on isotretinoin and the patient was comfortable in maintaining the registration as a female of childbearing potential.”

This is not an issue for female transgender patients, who do not have a uterus and are not of childbearing potential. These patients are, however, at an increased risk of hormone-associated dermatoses.

“Transgender women taking estrogens experience rapid and prolonged low sebum production, resulting in xerosis and asteatotic eczema,” he said.

Another issue is when to prescribe finasteride for transgender men on testosterone who experience male pattern hair loss. He advised avoiding finasteride until body hair and other desired secondary sex characteristics are fully developed, which could be up to 2 years, Dr. Ginsberg said.

To make transgender patients more comfortable in the office, Dr. Ginsberg recommended the following:

• Modify intake forms. Allow for patients to write in their gender, instead of offering the option of male or female.

• Respect the use of correct pronouns. “If you have a transgender woman sitting in front of you, don’t refer to her as him,” he commented. Consider asking the patient which pronoun is preferred.

• Make no assumptions. “Gender identity has nothing to do with sexual orientation,” he said. “A person’s gender is however they self-identify, period.” It has nothing to do with clothing, hormones, surgery “or any other aspect of transitioning,” he explained. “If a patient sitting in front of you says that they are a man, it doesn’t matter what they look like or what they’ve had done, that person is a man.”

• Be comfortable about being uncomfortable. “The community is coming to understand that we don’t know everything. … and we may have questions, we may not understand the details of the surgery or medications that they’re on. So rather than ignore the issue altogether, ask them about it,” Dr. Ginsberg said. “They will be more excited that you care … and want to help, rather than ignore the issue altogether.” Dr. Ginsberg reported no relevant disclosures.

emechcatie@frontlinemedcom.com

This article was updated March 8, 2016.

*Correction, 03/15/2016: An earlier version of this article misstated Dr. Brian Ginsberg's name. 

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AAD: Derms need to be active in the alternative payment model development process

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WASHINGTON – Now is the time to work toward defining alternative payment models that are effective for dermatology in terms of both outcomes and payment, Dr. Marta J. VanBeek said at the annual meeting of the American Academy of Dermatology.

Alternative payment models (APMs) will steadily displace fee-for-service models in the shift to paying for value over volume. Regulations formally defining APMs, which were created to replace the sustainable growth rate formula in the Medicare Access and CHIP Reauthorization Act, are expected in the coming months.

Dr. Marta J. VanBeek
Dr. Marta J. VanBeek

The key is to make sure that APMs accommodate the complexities of treating a variety of patients, Dr. VanBeek, a professor at the University of Iowa, Iowa City, said. A one-size-fits-all patients approach can disincentivize caring for complex patients and severe disease.

The start of designing and supporting a proposed APM is good data, she said. The AAD’s recently launched DataDerm tool is an important piece for measuring the quality aspects of care, and its use could be an active part of designing high-quality APMs.

If approached the right way, and led by physicians rather than payers, APMs could result in “a sea change in the way we deliver medicine and may bring the joy back,” rather than have the focus on worrying about what was put in the EMR and what was billed.

The key to designing and properly applying an APM is to understand and manage risk. If not accurately accounted for as it is under the current fee-for-service system, risk could put doctors out of business.

“In an alternative payment model, you’d be paid a fixed amount and ... you would still be paid the same amount regardless of whether more care was sought or required by the patients you serve ... so all the financial risk is on you,” Dr. VanBeek said.

Under this scenario, a single outlier patient could be a financial disaster for a solo practitioner seeing only a few thousand patients a year. Consider the wide difference in the costs of treating a patient with severe psoriasis versus one with mild psoriasis. The disparity is risk adjusted for today’s fee-for-service environment, but those differences could get lost in a bundled payment that regards all psoriasis patients as having identical needs.

Part of the challenge ahead is “to correct misconceptions that people may have and ... to design [the APMs] to prevent a potential disaster,” Dr. VanBeek said.

To illustrate her point, she referenced a payment bundle, a form of alternative payment model, that was developed for joint replacement surgery by orthopedic surgeons at her university hospital. The surgeons designed the bundle and negotiated the price. They found a win-win solution for surgeons, patients, and payers; and the “orthopedics department is further in the black than it’s ever been in decades.”

At certain hospitals around the country, though, CMS is now mandating Medicare-developed joint replacement payment bundles. “Those hospitals are panicking because they know that [the CMS payment bundle] is not financially viable,” Dr. VanBeek said.

The lesson to be learned: Do your homework and define your APM or a model that is unlikely to work may be forced upon you. “One hospital has an APM for joint replacement that was developed by doctors. The other has a model that was developed by CMS. One works really, really well. One does not,” she said. “And that’s my caveat in saying that [dermatologists] really need to get involved” in creating specialty-appropriate APMs.

Dr. VanBeek said she had no financial disclosures.

gtwachtman@frontlinemedcom.com

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WASHINGTON – Now is the time to work toward defining alternative payment models that are effective for dermatology in terms of both outcomes and payment, Dr. Marta J. VanBeek said at the annual meeting of the American Academy of Dermatology.

Alternative payment models (APMs) will steadily displace fee-for-service models in the shift to paying for value over volume. Regulations formally defining APMs, which were created to replace the sustainable growth rate formula in the Medicare Access and CHIP Reauthorization Act, are expected in the coming months.

Dr. Marta J. VanBeek
Dr. Marta J. VanBeek

The key is to make sure that APMs accommodate the complexities of treating a variety of patients, Dr. VanBeek, a professor at the University of Iowa, Iowa City, said. A one-size-fits-all patients approach can disincentivize caring for complex patients and severe disease.

The start of designing and supporting a proposed APM is good data, she said. The AAD’s recently launched DataDerm tool is an important piece for measuring the quality aspects of care, and its use could be an active part of designing high-quality APMs.

If approached the right way, and led by physicians rather than payers, APMs could result in “a sea change in the way we deliver medicine and may bring the joy back,” rather than have the focus on worrying about what was put in the EMR and what was billed.

The key to designing and properly applying an APM is to understand and manage risk. If not accurately accounted for as it is under the current fee-for-service system, risk could put doctors out of business.

“In an alternative payment model, you’d be paid a fixed amount and ... you would still be paid the same amount regardless of whether more care was sought or required by the patients you serve ... so all the financial risk is on you,” Dr. VanBeek said.

Under this scenario, a single outlier patient could be a financial disaster for a solo practitioner seeing only a few thousand patients a year. Consider the wide difference in the costs of treating a patient with severe psoriasis versus one with mild psoriasis. The disparity is risk adjusted for today’s fee-for-service environment, but those differences could get lost in a bundled payment that regards all psoriasis patients as having identical needs.

Part of the challenge ahead is “to correct misconceptions that people may have and ... to design [the APMs] to prevent a potential disaster,” Dr. VanBeek said.

To illustrate her point, she referenced a payment bundle, a form of alternative payment model, that was developed for joint replacement surgery by orthopedic surgeons at her university hospital. The surgeons designed the bundle and negotiated the price. They found a win-win solution for surgeons, patients, and payers; and the “orthopedics department is further in the black than it’s ever been in decades.”

At certain hospitals around the country, though, CMS is now mandating Medicare-developed joint replacement payment bundles. “Those hospitals are panicking because they know that [the CMS payment bundle] is not financially viable,” Dr. VanBeek said.

The lesson to be learned: Do your homework and define your APM or a model that is unlikely to work may be forced upon you. “One hospital has an APM for joint replacement that was developed by doctors. The other has a model that was developed by CMS. One works really, really well. One does not,” she said. “And that’s my caveat in saying that [dermatologists] really need to get involved” in creating specialty-appropriate APMs.

Dr. VanBeek said she had no financial disclosures.

gtwachtman@frontlinemedcom.com

WASHINGTON – Now is the time to work toward defining alternative payment models that are effective for dermatology in terms of both outcomes and payment, Dr. Marta J. VanBeek said at the annual meeting of the American Academy of Dermatology.

Alternative payment models (APMs) will steadily displace fee-for-service models in the shift to paying for value over volume. Regulations formally defining APMs, which were created to replace the sustainable growth rate formula in the Medicare Access and CHIP Reauthorization Act, are expected in the coming months.

Dr. Marta J. VanBeek
Dr. Marta J. VanBeek

The key is to make sure that APMs accommodate the complexities of treating a variety of patients, Dr. VanBeek, a professor at the University of Iowa, Iowa City, said. A one-size-fits-all patients approach can disincentivize caring for complex patients and severe disease.

The start of designing and supporting a proposed APM is good data, she said. The AAD’s recently launched DataDerm tool is an important piece for measuring the quality aspects of care, and its use could be an active part of designing high-quality APMs.

If approached the right way, and led by physicians rather than payers, APMs could result in “a sea change in the way we deliver medicine and may bring the joy back,” rather than have the focus on worrying about what was put in the EMR and what was billed.

The key to designing and properly applying an APM is to understand and manage risk. If not accurately accounted for as it is under the current fee-for-service system, risk could put doctors out of business.

“In an alternative payment model, you’d be paid a fixed amount and ... you would still be paid the same amount regardless of whether more care was sought or required by the patients you serve ... so all the financial risk is on you,” Dr. VanBeek said.

Under this scenario, a single outlier patient could be a financial disaster for a solo practitioner seeing only a few thousand patients a year. Consider the wide difference in the costs of treating a patient with severe psoriasis versus one with mild psoriasis. The disparity is risk adjusted for today’s fee-for-service environment, but those differences could get lost in a bundled payment that regards all psoriasis patients as having identical needs.

Part of the challenge ahead is “to correct misconceptions that people may have and ... to design [the APMs] to prevent a potential disaster,” Dr. VanBeek said.

To illustrate her point, she referenced a payment bundle, a form of alternative payment model, that was developed for joint replacement surgery by orthopedic surgeons at her university hospital. The surgeons designed the bundle and negotiated the price. They found a win-win solution for surgeons, patients, and payers; and the “orthopedics department is further in the black than it’s ever been in decades.”

At certain hospitals around the country, though, CMS is now mandating Medicare-developed joint replacement payment bundles. “Those hospitals are panicking because they know that [the CMS payment bundle] is not financially viable,” Dr. VanBeek said.

The lesson to be learned: Do your homework and define your APM or a model that is unlikely to work may be forced upon you. “One hospital has an APM for joint replacement that was developed by doctors. The other has a model that was developed by CMS. One works really, really well. One does not,” she said. “And that’s my caveat in saying that [dermatologists] really need to get involved” in creating specialty-appropriate APMs.

Dr. VanBeek said she had no financial disclosures.

gtwachtman@frontlinemedcom.com

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Children who have stem cell transplants need skin exams, sun protection

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WASHINGTON – Children who have had a hematopoietic stem cell transplant (HSCT) have an increased risk of benign and atypical nevi, Dr. Johanna Sheu reported at the annual meeting of the American Academy of Dermatology.

These patients need to have routine skin exams and be educated about sun protection needs, she said. Based on her study, these needs are not routinely met.

At least 1 year after undergoing HSCT at Boston Children’s Hospital, 85 posttransplant patients had significantly more nevi and more atypical nevi than did 85 healthy controls who were matched by age, gender, and Fitzpatrick skin type. In addition, 41% of the transplant recipients had at least one actinic keratosis, a basal or squamous cell carcinoma, or a solar lentigo; 11% had at least one nevus spilus.

Moreover, “sun protection … and dermatology follow-up was poor” among the transplant recipients, said Dr. Sheu, of MassGeneral Hospital for Children, Boston. About 40% of the transplant recipients reported having a sunburn since their transplant, only 15% reported daily use of sunscreen, and 53% said they did not recall being told that sunburn could trigger graft-versus-host disease (GVHD).

About one-third of the patients had never seen a dermatologist; of those who had, two-thirds had only seen the dermatologist once, Dr. Sheu reported.

Late skin effects of HSCT are not as well described in children as they are in adults, she said. In adults, late skin effects include vitiligo, psoriasis, nonmelanoma skin cancers, and an increased nevi count.

The children in the study had undergone an HSCT between 1998 and 2013, at a median age of about 7 years (range was 1 month to 19 years). At the time of their skin exams, their mean age was 14 years, and they had been followed for a median of almost 4 years. Nevi were counted on the forearms, backs, legs, palms, and soles.

The median nevi count was 44 nevi, significantly more than the level seen in control subjects. Transplant recipients also had significantly more nevi in sun-exposed areas of the body, as well as on the palms and soles. Transplant recipients were more likely to have atypical nevi and to have nevi greater than 5 mm in diameter.

In addition to fair skin, factors associated with an increase in the overall nevi count included being older than age 10 at the time of the transplant and having total body irradiation, pretransplant chemotherapy, and myeloablative conditioning. Having had a sunburn since the transplant, reported by 40%, was also a risk factor.

Chronic GVHD and chronic GVHD of the skin were associated with the presence of atypical nevi; acute GVHD, the duration of immune suppression, and the use of topical steroids or calcineurin inhibitors were not associated with increased risk of atypical nevi.

She and her coinvestigators are currently analyzing the pathogenesis of these late effects in this population, and autoimmune skin conditions – vitiligo and alopecia – in 25% of the transplant recipients in the study.

In 2013, 1,100 children under aged 16 years in the United States underwent a bone marrow transplant, she noted.

Dr. Sheu had no disclosures.

emechcatie@frontlinemedcom.com

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WASHINGTON – Children who have had a hematopoietic stem cell transplant (HSCT) have an increased risk of benign and atypical nevi, Dr. Johanna Sheu reported at the annual meeting of the American Academy of Dermatology.

These patients need to have routine skin exams and be educated about sun protection needs, she said. Based on her study, these needs are not routinely met.

At least 1 year after undergoing HSCT at Boston Children’s Hospital, 85 posttransplant patients had significantly more nevi and more atypical nevi than did 85 healthy controls who were matched by age, gender, and Fitzpatrick skin type. In addition, 41% of the transplant recipients had at least one actinic keratosis, a basal or squamous cell carcinoma, or a solar lentigo; 11% had at least one nevus spilus.

Moreover, “sun protection … and dermatology follow-up was poor” among the transplant recipients, said Dr. Sheu, of MassGeneral Hospital for Children, Boston. About 40% of the transplant recipients reported having a sunburn since their transplant, only 15% reported daily use of sunscreen, and 53% said they did not recall being told that sunburn could trigger graft-versus-host disease (GVHD).

About one-third of the patients had never seen a dermatologist; of those who had, two-thirds had only seen the dermatologist once, Dr. Sheu reported.

Late skin effects of HSCT are not as well described in children as they are in adults, she said. In adults, late skin effects include vitiligo, psoriasis, nonmelanoma skin cancers, and an increased nevi count.

The children in the study had undergone an HSCT between 1998 and 2013, at a median age of about 7 years (range was 1 month to 19 years). At the time of their skin exams, their mean age was 14 years, and they had been followed for a median of almost 4 years. Nevi were counted on the forearms, backs, legs, palms, and soles.

The median nevi count was 44 nevi, significantly more than the level seen in control subjects. Transplant recipients also had significantly more nevi in sun-exposed areas of the body, as well as on the palms and soles. Transplant recipients were more likely to have atypical nevi and to have nevi greater than 5 mm in diameter.

In addition to fair skin, factors associated with an increase in the overall nevi count included being older than age 10 at the time of the transplant and having total body irradiation, pretransplant chemotherapy, and myeloablative conditioning. Having had a sunburn since the transplant, reported by 40%, was also a risk factor.

Chronic GVHD and chronic GVHD of the skin were associated with the presence of atypical nevi; acute GVHD, the duration of immune suppression, and the use of topical steroids or calcineurin inhibitors were not associated with increased risk of atypical nevi.

She and her coinvestigators are currently analyzing the pathogenesis of these late effects in this population, and autoimmune skin conditions – vitiligo and alopecia – in 25% of the transplant recipients in the study.

In 2013, 1,100 children under aged 16 years in the United States underwent a bone marrow transplant, she noted.

Dr. Sheu had no disclosures.

emechcatie@frontlinemedcom.com

WASHINGTON – Children who have had a hematopoietic stem cell transplant (HSCT) have an increased risk of benign and atypical nevi, Dr. Johanna Sheu reported at the annual meeting of the American Academy of Dermatology.

These patients need to have routine skin exams and be educated about sun protection needs, she said. Based on her study, these needs are not routinely met.

At least 1 year after undergoing HSCT at Boston Children’s Hospital, 85 posttransplant patients had significantly more nevi and more atypical nevi than did 85 healthy controls who were matched by age, gender, and Fitzpatrick skin type. In addition, 41% of the transplant recipients had at least one actinic keratosis, a basal or squamous cell carcinoma, or a solar lentigo; 11% had at least one nevus spilus.

Moreover, “sun protection … and dermatology follow-up was poor” among the transplant recipients, said Dr. Sheu, of MassGeneral Hospital for Children, Boston. About 40% of the transplant recipients reported having a sunburn since their transplant, only 15% reported daily use of sunscreen, and 53% said they did not recall being told that sunburn could trigger graft-versus-host disease (GVHD).

About one-third of the patients had never seen a dermatologist; of those who had, two-thirds had only seen the dermatologist once, Dr. Sheu reported.

Late skin effects of HSCT are not as well described in children as they are in adults, she said. In adults, late skin effects include vitiligo, psoriasis, nonmelanoma skin cancers, and an increased nevi count.

The children in the study had undergone an HSCT between 1998 and 2013, at a median age of about 7 years (range was 1 month to 19 years). At the time of their skin exams, their mean age was 14 years, and they had been followed for a median of almost 4 years. Nevi were counted on the forearms, backs, legs, palms, and soles.

The median nevi count was 44 nevi, significantly more than the level seen in control subjects. Transplant recipients also had significantly more nevi in sun-exposed areas of the body, as well as on the palms and soles. Transplant recipients were more likely to have atypical nevi and to have nevi greater than 5 mm in diameter.

In addition to fair skin, factors associated with an increase in the overall nevi count included being older than age 10 at the time of the transplant and having total body irradiation, pretransplant chemotherapy, and myeloablative conditioning. Having had a sunburn since the transplant, reported by 40%, was also a risk factor.

Chronic GVHD and chronic GVHD of the skin were associated with the presence of atypical nevi; acute GVHD, the duration of immune suppression, and the use of topical steroids or calcineurin inhibitors were not associated with increased risk of atypical nevi.

She and her coinvestigators are currently analyzing the pathogenesis of these late effects in this population, and autoimmune skin conditions – vitiligo and alopecia – in 25% of the transplant recipients in the study.

In 2013, 1,100 children under aged 16 years in the United States underwent a bone marrow transplant, she noted.

Dr. Sheu had no disclosures.

emechcatie@frontlinemedcom.com

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Key clinical point: Children who have had a hematopoietic stem cell transplant need to have routine skin exams and be educated about sun protection needs.

Major finding: 41% of the transplant recipients had at least one actinic keratosis, a basal or squamous cell carcinoma, or a solar lentigo; 11% had at least one nevus spilus.

Data source: A single-center study of 85 posttransplant patients and 85 healthy controls who were matched by age, gender, and Fitzpatrick skin type.

Disclosures: The study was not sponsored and Dr. Sheu had no disclosures.

VIDEO: Study links hair loss in black women with genetics

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WASHINGTON – Almost 41% of black women surveyed described hair loss that was consistent with central centrifugal cicatricial alopecia (CCCA), but only about 9% said they had been diagnosed with the condition, Dr. Yolanda Lenzy reported at the annual meeting of the American Academy of Dermatology.

In a video interview at the meeting, Dr. Lenzy of the University of Connecticut, Farmington, discussed the results of a hair survey she conducted with the Black Women’s Health Study at Boston University’s Slone Epidemiology Center. Nearly 6,000 women have completed the survey to date.

“For many years, it was thought to be due to hair styling practices,” but there are new data showing that genetics can be an important cause, she said, referring to research from South Africa indicating that CCCA can be inherited in an autosomal dominant fashion.

Dr. Lenzy, who practices dermatology in Chicopee, Mass., used a central hair loss photographic scale in the study, which also can be helpful in the office to monitor hair loss and “to quantify how much hair loss a person has … in terms of: Are they getting worse? Do they go from stage 3 to stage 5 or stage 1 to stage 3?”

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

emechcatie@frontlinemedcom.com

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WASHINGTON – Almost 41% of black women surveyed described hair loss that was consistent with central centrifugal cicatricial alopecia (CCCA), but only about 9% said they had been diagnosed with the condition, Dr. Yolanda Lenzy reported at the annual meeting of the American Academy of Dermatology.

In a video interview at the meeting, Dr. Lenzy of the University of Connecticut, Farmington, discussed the results of a hair survey she conducted with the Black Women’s Health Study at Boston University’s Slone Epidemiology Center. Nearly 6,000 women have completed the survey to date.

“For many years, it was thought to be due to hair styling practices,” but there are new data showing that genetics can be an important cause, she said, referring to research from South Africa indicating that CCCA can be inherited in an autosomal dominant fashion.

Dr. Lenzy, who practices dermatology in Chicopee, Mass., used a central hair loss photographic scale in the study, which also can be helpful in the office to monitor hair loss and “to quantify how much hair loss a person has … in terms of: Are they getting worse? Do they go from stage 3 to stage 5 or stage 1 to stage 3?”

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

emechcatie@frontlinemedcom.com

WASHINGTON – Almost 41% of black women surveyed described hair loss that was consistent with central centrifugal cicatricial alopecia (CCCA), but only about 9% said they had been diagnosed with the condition, Dr. Yolanda Lenzy reported at the annual meeting of the American Academy of Dermatology.

In a video interview at the meeting, Dr. Lenzy of the University of Connecticut, Farmington, discussed the results of a hair survey she conducted with the Black Women’s Health Study at Boston University’s Slone Epidemiology Center. Nearly 6,000 women have completed the survey to date.

“For many years, it was thought to be due to hair styling practices,” but there are new data showing that genetics can be an important cause, she said, referring to research from South Africa indicating that CCCA can be inherited in an autosomal dominant fashion.

Dr. Lenzy, who practices dermatology in Chicopee, Mass., used a central hair loss photographic scale in the study, which also can be helpful in the office to monitor hair loss and “to quantify how much hair loss a person has … in terms of: Are they getting worse? Do they go from stage 3 to stage 5 or stage 1 to stage 3?”

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

emechcatie@frontlinemedcom.com

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Minimally invasive system smooths cellulite for up to 3 years

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Minimally invasive system smooths cellulite for up to 3 years

WASHINGTON – The key to treating cellulite may be as simple as cutting a tiny tether.

Vertical bundles of fibrous septae that run through subdermal fat and anchor the skin seem to cause the dimples and bulges that annoy up to 95% of women. Releasing those fibers with a minimally invasive instrument causes an immediate smoothing of the skin – an improvement that appears to last for at least 3 years, according to data presented at the annual meeting of the American Academy of Dermatology.

“At 3 years, the data are remarkably consistent,” said Dr. Michael Kaminer of Yale University, New Haven, Conn. “No one was unsatisfied with the result, and in fact, 93% of the patients were still satisfied or very satisfied. So I would say this meets the criteria of something that is reasonable to offer to our patients.

The Cellfina system can treat up to 30 dimples in a single hour-long session, according to Dr. Kaminer, who discussed the procedure in a video interview. The procedure costs anywhere from $2,500-$6,000 per session, depending on how many dimples are treated.

The device consists of a circular area that provides enough suction to elevate the skin over each dimple. One disposable click-in module contains a 22-gauge multibore needle that delivers local anesthetic. After the anesthetic is delivered, a second module clicks into place. This contains an 18-gauge probe tipped with a very small triangular blade. Inserted 5-6 mm below the skin, the probe can be pivoted back and forth, cutting the septae under the dimple. This releases their constricting effect on the skin, which immediately rebounds and appears smooth. The system does not remove any fat.

Cellfina’s earlier data earned it a 2-year Food and Drug Administration clearance for cellulite treatment. The data presented at the meeting confirm its effect at 3 years, Dr. Kaminer said, and form the basis of an application for a 3-year clearance.

The follow-up study comprised 45 women who had undergone the procedure and were reevaluated by several means: a blinded physician rating of before and after pictures, and a 1- 5 point patient self-evaluation scale, with a change of at least 1 point rated as “satisfactory.”

These women represented all six Fitzpatrick skin types. They were a mean of 40 years old at baseline and had a mean body mass index of 25 kg/m2.

Independent, blinded physicians were given before-and-after photos of all patients and asked to identify which photo showed change. All of the physicians correctly identified all of the “after” photos.

“This was not a subtle change they were seeing in the pictures,” Dr. Kaminer said. “It’s a very, very noticeable improvement that a physician who doesn’t treat cellulite would recognize as something having been done.”

At the 1-year follow-up, patients reported an average improvement of 2 points on the severity scale. This was largely maintained at 3 years; 42 patients (93%) remained satisfied. Of the entire group, 19 patients said they were very satisfied, 23 were “satisfied,” and the rest were neutral. No one was unsatisfied, he noted.

“What this means is that about half of patients had an amazing result and the rest had a very good result,” Dr. Kaminer said. He added that none of the women had requested any retreatment. “Most felt like the improvement they experienced was good enough not to need more.”

In fact, he said, the 3-year follow-up photos seem to show that the contours of the treated areas continued to improve. “It certainly looks that way. We have no idea why this would be,” he said but suggested that once women feel better about the appearance of their legs and rear, they may be more motivated to make such beneficial lifestyle changes as improved diet and regular exercise.

The system has mostly been used for buttock cellulite, but that’s expanding. Dr. Kaminer said. “We are treating a lot of outer thighs now, and we’re starting to move into anterior thighs and seeing excellent results.”

He added that the procedure is very safe and quite easy for patients to tolerate. Postprocedural pain is minimal and managed with nonprescription acetaminophen. Aftercare consists only of wearing a light compression garment – like a body shaper – for a week after the procedure. Adverse events included slight ecchymosis that cleared rapidly; one patient experienced scratching for pruritus.

Some women, however, will experience a residual firmness in treated areas. It’s not clear what this is, Dr. Kaminer said, but it recedes spontaneously over 6-12 months. “If it’s really bothering them, you can inject a little steroid into it. It can sometimes go away with massage.”

 

 

Informing patients about the possibility is key, he added. “If you tell them they might experience it, it’s really not a big deal to them.”

Dr. Kaminer received financial benefits during the initial development and deployment of Cellfina, but said he has no financial ties to the company now.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

msullivan@frontlinemedcom.com

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WASHINGTON – The key to treating cellulite may be as simple as cutting a tiny tether.

Vertical bundles of fibrous septae that run through subdermal fat and anchor the skin seem to cause the dimples and bulges that annoy up to 95% of women. Releasing those fibers with a minimally invasive instrument causes an immediate smoothing of the skin – an improvement that appears to last for at least 3 years, according to data presented at the annual meeting of the American Academy of Dermatology.

“At 3 years, the data are remarkably consistent,” said Dr. Michael Kaminer of Yale University, New Haven, Conn. “No one was unsatisfied with the result, and in fact, 93% of the patients were still satisfied or very satisfied. So I would say this meets the criteria of something that is reasonable to offer to our patients.

The Cellfina system can treat up to 30 dimples in a single hour-long session, according to Dr. Kaminer, who discussed the procedure in a video interview. The procedure costs anywhere from $2,500-$6,000 per session, depending on how many dimples are treated.

The device consists of a circular area that provides enough suction to elevate the skin over each dimple. One disposable click-in module contains a 22-gauge multibore needle that delivers local anesthetic. After the anesthetic is delivered, a second module clicks into place. This contains an 18-gauge probe tipped with a very small triangular blade. Inserted 5-6 mm below the skin, the probe can be pivoted back and forth, cutting the septae under the dimple. This releases their constricting effect on the skin, which immediately rebounds and appears smooth. The system does not remove any fat.

Cellfina’s earlier data earned it a 2-year Food and Drug Administration clearance for cellulite treatment. The data presented at the meeting confirm its effect at 3 years, Dr. Kaminer said, and form the basis of an application for a 3-year clearance.

The follow-up study comprised 45 women who had undergone the procedure and were reevaluated by several means: a blinded physician rating of before and after pictures, and a 1- 5 point patient self-evaluation scale, with a change of at least 1 point rated as “satisfactory.”

These women represented all six Fitzpatrick skin types. They were a mean of 40 years old at baseline and had a mean body mass index of 25 kg/m2.

Independent, blinded physicians were given before-and-after photos of all patients and asked to identify which photo showed change. All of the physicians correctly identified all of the “after” photos.

“This was not a subtle change they were seeing in the pictures,” Dr. Kaminer said. “It’s a very, very noticeable improvement that a physician who doesn’t treat cellulite would recognize as something having been done.”

At the 1-year follow-up, patients reported an average improvement of 2 points on the severity scale. This was largely maintained at 3 years; 42 patients (93%) remained satisfied. Of the entire group, 19 patients said they were very satisfied, 23 were “satisfied,” and the rest were neutral. No one was unsatisfied, he noted.

“What this means is that about half of patients had an amazing result and the rest had a very good result,” Dr. Kaminer said. He added that none of the women had requested any retreatment. “Most felt like the improvement they experienced was good enough not to need more.”

In fact, he said, the 3-year follow-up photos seem to show that the contours of the treated areas continued to improve. “It certainly looks that way. We have no idea why this would be,” he said but suggested that once women feel better about the appearance of their legs and rear, they may be more motivated to make such beneficial lifestyle changes as improved diet and regular exercise.

The system has mostly been used for buttock cellulite, but that’s expanding. Dr. Kaminer said. “We are treating a lot of outer thighs now, and we’re starting to move into anterior thighs and seeing excellent results.”

He added that the procedure is very safe and quite easy for patients to tolerate. Postprocedural pain is minimal and managed with nonprescription acetaminophen. Aftercare consists only of wearing a light compression garment – like a body shaper – for a week after the procedure. Adverse events included slight ecchymosis that cleared rapidly; one patient experienced scratching for pruritus.

Some women, however, will experience a residual firmness in treated areas. It’s not clear what this is, Dr. Kaminer said, but it recedes spontaneously over 6-12 months. “If it’s really bothering them, you can inject a little steroid into it. It can sometimes go away with massage.”

 

 

Informing patients about the possibility is key, he added. “If you tell them they might experience it, it’s really not a big deal to them.”

Dr. Kaminer received financial benefits during the initial development and deployment of Cellfina, but said he has no financial ties to the company now.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

msullivan@frontlinemedcom.com

WASHINGTON – The key to treating cellulite may be as simple as cutting a tiny tether.

Vertical bundles of fibrous septae that run through subdermal fat and anchor the skin seem to cause the dimples and bulges that annoy up to 95% of women. Releasing those fibers with a minimally invasive instrument causes an immediate smoothing of the skin – an improvement that appears to last for at least 3 years, according to data presented at the annual meeting of the American Academy of Dermatology.

“At 3 years, the data are remarkably consistent,” said Dr. Michael Kaminer of Yale University, New Haven, Conn. “No one was unsatisfied with the result, and in fact, 93% of the patients were still satisfied or very satisfied. So I would say this meets the criteria of something that is reasonable to offer to our patients.

The Cellfina system can treat up to 30 dimples in a single hour-long session, according to Dr. Kaminer, who discussed the procedure in a video interview. The procedure costs anywhere from $2,500-$6,000 per session, depending on how many dimples are treated.

The device consists of a circular area that provides enough suction to elevate the skin over each dimple. One disposable click-in module contains a 22-gauge multibore needle that delivers local anesthetic. After the anesthetic is delivered, a second module clicks into place. This contains an 18-gauge probe tipped with a very small triangular blade. Inserted 5-6 mm below the skin, the probe can be pivoted back and forth, cutting the septae under the dimple. This releases their constricting effect on the skin, which immediately rebounds and appears smooth. The system does not remove any fat.

Cellfina’s earlier data earned it a 2-year Food and Drug Administration clearance for cellulite treatment. The data presented at the meeting confirm its effect at 3 years, Dr. Kaminer said, and form the basis of an application for a 3-year clearance.

The follow-up study comprised 45 women who had undergone the procedure and were reevaluated by several means: a blinded physician rating of before and after pictures, and a 1- 5 point patient self-evaluation scale, with a change of at least 1 point rated as “satisfactory.”

These women represented all six Fitzpatrick skin types. They were a mean of 40 years old at baseline and had a mean body mass index of 25 kg/m2.

Independent, blinded physicians were given before-and-after photos of all patients and asked to identify which photo showed change. All of the physicians correctly identified all of the “after” photos.

“This was not a subtle change they were seeing in the pictures,” Dr. Kaminer said. “It’s a very, very noticeable improvement that a physician who doesn’t treat cellulite would recognize as something having been done.”

At the 1-year follow-up, patients reported an average improvement of 2 points on the severity scale. This was largely maintained at 3 years; 42 patients (93%) remained satisfied. Of the entire group, 19 patients said they were very satisfied, 23 were “satisfied,” and the rest were neutral. No one was unsatisfied, he noted.

“What this means is that about half of patients had an amazing result and the rest had a very good result,” Dr. Kaminer said. He added that none of the women had requested any retreatment. “Most felt like the improvement they experienced was good enough not to need more.”

In fact, he said, the 3-year follow-up photos seem to show that the contours of the treated areas continued to improve. “It certainly looks that way. We have no idea why this would be,” he said but suggested that once women feel better about the appearance of their legs and rear, they may be more motivated to make such beneficial lifestyle changes as improved diet and regular exercise.

The system has mostly been used for buttock cellulite, but that’s expanding. Dr. Kaminer said. “We are treating a lot of outer thighs now, and we’re starting to move into anterior thighs and seeing excellent results.”

He added that the procedure is very safe and quite easy for patients to tolerate. Postprocedural pain is minimal and managed with nonprescription acetaminophen. Aftercare consists only of wearing a light compression garment – like a body shaper – for a week after the procedure. Adverse events included slight ecchymosis that cleared rapidly; one patient experienced scratching for pruritus.

Some women, however, will experience a residual firmness in treated areas. It’s not clear what this is, Dr. Kaminer said, but it recedes spontaneously over 6-12 months. “If it’s really bothering them, you can inject a little steroid into it. It can sometimes go away with massage.”

 

 

Informing patients about the possibility is key, he added. “If you tell them they might experience it, it’s really not a big deal to them.”

Dr. Kaminer received financial benefits during the initial development and deployment of Cellfina, but said he has no financial ties to the company now.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

msullivan@frontlinemedcom.com

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Key clinical point: The Cellfina cellulite treatment system appears to confer a lasting benefit.

Major finding: Three years after the procedure, 93% of women were either “satisfied” or “very satisfied” with their results.

Data source: The follow-up study comprised 45 women.

Disclosures: Dr. Kaminer had financial ties with the company during the product’s development and early deployment. He is no longer associated with it.

VIDEO – Microneedling: Simple procedure offers good results for wrinkles, pores, and more

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VIDEO – Microneedling: Simple procedure offers good results for wrinkles, pores, and more

WASHINGTON – Microneedling is one of the hottest new trends in aesthetic dermatology and is easy to incorporate into any practice, according to Washington dermatologist Dr. Tina Alster.

Microneedling involves using an updated microneedle device to create small wounds on a patient’s area of concern. Perioral wrinkles, large pores on the nose, certain scars, and stretch marks all respond well to the procedure, Dr. Alster said at the annual meeting of the American Academy of Dermatology.

“I’ve been blown away by the fact that microneedling works as well as it does,” Dr. Alster added, noting that it’s not hard to do, it’s not hard to heal from, and it offers good results.

In this video interview, Dr. Alster explains how to do this microneedling procedures and how to incorporate the device into practice.

 

 

dfulton@frontlinemedcom.com

On Twitter @denisefulton

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WASHINGTON – Microneedling is one of the hottest new trends in aesthetic dermatology and is easy to incorporate into any practice, according to Washington dermatologist Dr. Tina Alster.

Microneedling involves using an updated microneedle device to create small wounds on a patient’s area of concern. Perioral wrinkles, large pores on the nose, certain scars, and stretch marks all respond well to the procedure, Dr. Alster said at the annual meeting of the American Academy of Dermatology.

“I’ve been blown away by the fact that microneedling works as well as it does,” Dr. Alster added, noting that it’s not hard to do, it’s not hard to heal from, and it offers good results.

In this video interview, Dr. Alster explains how to do this microneedling procedures and how to incorporate the device into practice.

 

 

dfulton@frontlinemedcom.com

On Twitter @denisefulton

WASHINGTON – Microneedling is one of the hottest new trends in aesthetic dermatology and is easy to incorporate into any practice, according to Washington dermatologist Dr. Tina Alster.

Microneedling involves using an updated microneedle device to create small wounds on a patient’s area of concern. Perioral wrinkles, large pores on the nose, certain scars, and stretch marks all respond well to the procedure, Dr. Alster said at the annual meeting of the American Academy of Dermatology.

“I’ve been blown away by the fact that microneedling works as well as it does,” Dr. Alster added, noting that it’s not hard to do, it’s not hard to heal from, and it offers good results.

In this video interview, Dr. Alster explains how to do this microneedling procedures and how to incorporate the device into practice.

 

 

dfulton@frontlinemedcom.com

On Twitter @denisefulton

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