Upper GI Tract

Key clinical point: The phenotypes of eosinophilic esophagitis (EoE) have evolved over the past two decades, with an increase in both age at diagnosis and age at onset of symptoms.

Major finding: The interval 2017-2021 vs 2002-2006 was associated with a significant increase in age at diagnosis (31.8 vs 22.0 years), frequency of dysphagia (92% vs 67%), proportion of patients with mixed presentation of inflammatory and fibrostenotic findings (68% vs 26%), and proportion of patients (age groups ≥18 years and ≥12 years) having later EoE symptom onset (all P < .001). The increase in the mixed phenotype rate persisted for the intervals after multivariate adjustment (adjusted odds ratio 1.51/interval; 95% CI 1.31-1.73).

Study details: This retrospective cohort study included 1187 adults or children (age < 18 years) with newly diagnosed EoE.

Disclosures: This study was supported by grants from the US National Institutes of Health. The authors declared no conflicts of interest.

Source: Kiran A et al. Increasing age at the time of diagnosis and evolving phenotypes of eosinophilic esophagitis over 20 years. Dig Dis Sci. 2023 (Nov 15). doi: 10.1007/s10620-023-08165-z

Key clinical point: The phenotypes of eosinophilic esophagitis (EoE) have evolved over the past two decades, with an increase in both age at diagnosis and age at onset of symptoms.

Major finding: The interval 2017-2021 vs 2002-2006 was associated with a significant increase in age at diagnosis (31.8 vs 22.0 years), frequency of dysphagia (92% vs 67%), proportion of patients with mixed presentation of inflammatory and fibrostenotic findings (68% vs 26%), and proportion of patients (age groups ≥18 years and ≥12 years) having later EoE symptom onset (all P < .001). The increase in the mixed phenotype rate persisted for the intervals after multivariate adjustment (adjusted odds ratio 1.51/interval; 95% CI 1.31-1.73).

Study details: This retrospective cohort study included 1187 adults or children (age < 18 years) with newly diagnosed EoE.

Disclosures: This study was supported by grants from the US National Institutes of Health. The authors declared no conflicts of interest.

Source: Kiran A et al. Increasing age at the time of diagnosis and evolving phenotypes of eosinophilic esophagitis over 20 years. Dig Dis Sci. 2023 (Nov 15). doi: 10.1007/s10620-023-08165-z

Key clinical point: The phenotypes of eosinophilic esophagitis (EoE) have evolved over the past two decades, with an increase in both age at diagnosis and age at onset of symptoms.

Major finding: The interval 2017-2021 vs 2002-2006 was associated with a significant increase in age at diagnosis (31.8 vs 22.0 years), frequency of dysphagia (92% vs 67%), proportion of patients with mixed presentation of inflammatory and fibrostenotic findings (68% vs 26%), and proportion of patients (age groups ≥18 years and ≥12 years) having later EoE symptom onset (all P < .001). The increase in the mixed phenotype rate persisted for the intervals after multivariate adjustment (adjusted odds ratio 1.51/interval; 95% CI 1.31-1.73).

Study details: This retrospective cohort study included 1187 adults or children (age < 18 years) with newly diagnosed EoE.

Disclosures: This study was supported by grants from the US National Institutes of Health. The authors declared no conflicts of interest.

Source: Kiran A et al. Increasing age at the time of diagnosis and evolving phenotypes of eosinophilic esophagitis over 20 years. Dig Dis Sci. 2023 (Nov 15). doi: 10.1007/s10620-023-08165-z

Key clinical point: Whole-blood IL5RA expression could serve as a noninvasive biomarker for the diagnosis of eosinophilic esophagitis (EoE).

Major finding: The expression of IL5RA was 2.36-fold higher in patients with EoE vs control individuals (P = .001). The value of area under the concentration-time curve for differentiating between the two groups was 0.85. IL5RA expression levels correlated significantly with the baseline tissue esophageal eosinophil counts on biopsy specimens (Pearson R = 0.62; P < .0001) and were associated with the total baseline endoscopy reference score (Pearson R = 0.52; P < .001).

Study details: This prospective study analyzed the whole blood samples of 20 patients with EoE who were treated with topical corticosteroids for 8 weeks before undergoing endoscopy and 20 control individuals without EoE.

Disclosures: This study was supported by grants from the US National Institutes of Health. The authors declared no conflicts of interest.

Source: Sninsky JA et al. Peripheral blood IL5RA gene expression as a diagnostic biomarker for eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2023 (Nov 7). doi: 10.1016/j.cgh.2023.10.028

Key clinical point: Whole-blood IL5RA expression could serve as a noninvasive biomarker for the diagnosis of eosinophilic esophagitis (EoE).

Major finding: The expression of IL5RA was 2.36-fold higher in patients with EoE vs control individuals (P = .001). The value of area under the concentration-time curve for differentiating between the two groups was 0.85. IL5RA expression levels correlated significantly with the baseline tissue esophageal eosinophil counts on biopsy specimens (Pearson R = 0.62; P < .0001) and were associated with the total baseline endoscopy reference score (Pearson R = 0.52; P < .001).

Study details: This prospective study analyzed the whole blood samples of 20 patients with EoE who were treated with topical corticosteroids for 8 weeks before undergoing endoscopy and 20 control individuals without EoE.

Disclosures: This study was supported by grants from the US National Institutes of Health. The authors declared no conflicts of interest.

Source: Sninsky JA et al. Peripheral blood IL5RA gene expression as a diagnostic biomarker for eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2023 (Nov 7). doi: 10.1016/j.cgh.2023.10.028

Key clinical point: Whole-blood IL5RA expression could serve as a noninvasive biomarker for the diagnosis of eosinophilic esophagitis (EoE).

Major finding: The expression of IL5RA was 2.36-fold higher in patients with EoE vs control individuals (P = .001). The value of area under the concentration-time curve for differentiating between the two groups was 0.85. IL5RA expression levels correlated significantly with the baseline tissue esophageal eosinophil counts on biopsy specimens (Pearson R = 0.62; P < .0001) and were associated with the total baseline endoscopy reference score (Pearson R = 0.52; P < .001).

Study details: This prospective study analyzed the whole blood samples of 20 patients with EoE who were treated with topical corticosteroids for 8 weeks before undergoing endoscopy and 20 control individuals without EoE.

Disclosures: This study was supported by grants from the US National Institutes of Health. The authors declared no conflicts of interest.

Source: Sninsky JA et al. Peripheral blood IL5RA gene expression as a diagnostic biomarker for eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2023 (Nov 7). doi: 10.1016/j.cgh.2023.10.028

Key clinical point: A family history of eczema and a diet lacking allergenic foods, such as milk, increased the risk for incident eosinophilic esophagitis (EoE) in children with aerodigestive dysfunction who underwent triple endoscopy.

Major finding: A family history of eczema increased the odds of a future diagnosis EoE by ~4 times (odds ratio [OR] 4.02; P = .006) whereas a diet containing dairy significantly lowered the risk for incident EoE (OR 0.26, P = .02).

Study details: Findings are from a study including 119 patients with aerodigestive dysfunction who were age 0-21 years and underwent triple endoscopy (flexible bronchoscopy, rigid direct laryngoscopy + bronchoscopy, and esophagoscopy with biopsy), of whom 19 had EoE.

Disclosures: This study was supported by the US National Institutes of Health/National Center for Advancing Translational Science. AM Loizides declared serving as the Medical Director of Clinical Development at Albireo Pharma.

Source: Moran S et al. Factors associated with eosinophilic esophagitis in an urban, tertiary care pediatric aerodigestive population undergoing triple endoscopy. Am J Otolaryngol. 2023;45(1):104096 (Nov 5). doi: 10.1016/j.amjoto.2023.104096

Key clinical point: A family history of eczema and a diet lacking allergenic foods, such as milk, increased the risk for incident eosinophilic esophagitis (EoE) in children with aerodigestive dysfunction who underwent triple endoscopy.

Major finding: A family history of eczema increased the odds of a future diagnosis EoE by ~4 times (odds ratio [OR] 4.02; P = .006) whereas a diet containing dairy significantly lowered the risk for incident EoE (OR 0.26, P = .02).

Study details: Findings are from a study including 119 patients with aerodigestive dysfunction who were age 0-21 years and underwent triple endoscopy (flexible bronchoscopy, rigid direct laryngoscopy + bronchoscopy, and esophagoscopy with biopsy), of whom 19 had EoE.

Disclosures: This study was supported by the US National Institutes of Health/National Center for Advancing Translational Science. AM Loizides declared serving as the Medical Director of Clinical Development at Albireo Pharma.

Source: Moran S et al. Factors associated with eosinophilic esophagitis in an urban, tertiary care pediatric aerodigestive population undergoing triple endoscopy. Am J Otolaryngol. 2023;45(1):104096 (Nov 5). doi: 10.1016/j.amjoto.2023.104096

Key clinical point: A family history of eczema and a diet lacking allergenic foods, such as milk, increased the risk for incident eosinophilic esophagitis (EoE) in children with aerodigestive dysfunction who underwent triple endoscopy.

Major finding: A family history of eczema increased the odds of a future diagnosis EoE by ~4 times (odds ratio [OR] 4.02; P = .006) whereas a diet containing dairy significantly lowered the risk for incident EoE (OR 0.26, P = .02).

Study details: Findings are from a study including 119 patients with aerodigestive dysfunction who were age 0-21 years and underwent triple endoscopy (flexible bronchoscopy, rigid direct laryngoscopy + bronchoscopy, and esophagoscopy with biopsy), of whom 19 had EoE.

Disclosures: This study was supported by the US National Institutes of Health/National Center for Advancing Translational Science. AM Loizides declared serving as the Medical Director of Clinical Development at Albireo Pharma.

Source: Moran S et al. Factors associated with eosinophilic esophagitis in an urban, tertiary care pediatric aerodigestive population undergoing triple endoscopy. Am J Otolaryngol. 2023;45(1):104096 (Nov 5). doi: 10.1016/j.amjoto.2023.104096

Key clinical point: The risk for inflammatory bowel diseases (IBD), particularly Crohn’s disease, was 3.5 times higher in patients with eosinophilic esophagitis (EoE).

Major finding: Compared with control individuals without EoE, patients with EoE were at a ~3.5-fold increased risk for IBD (adjusted hazard ratio [aHR] 3.56; 95% CI 1.79-7.11), particularly Crohn’s disease (aHR 3.39; 95% CI 1.2-9.60). When compared with siblings of patients with EoE, 12 patients with EoE were diagnosed with IBD later in life compared with 11 siblings, which corresponded to an aHR of 2.48 (95% CI 0.92-6.70).

Study details: Findings are from a nationwide cohort study including 1587 patients with histologically verified EoE and 7808 age- and sex-matched control individuals without EoE.

Disclosures: This study was funded by the Consortium of Eosinophilic Gastrointestinal Disease Researcher Training Program and Karolinska Institutet, Sweden. Some authors declared serving as consultants, advisors, or speakers for or receiving financial support, grants, or fees for lectures from Karolinska Institutet and other sources.

Source: Uchida AM et al. Eosinophilic esophagitis is associated with increased risk of later inflammatory bowel disease in a nationwide Swedish population cohort. United European Gastroenterol J. 2023 (Dec 7). doi: 10.1002/ueg2.12493

Key clinical point: The risk for inflammatory bowel diseases (IBD), particularly Crohn’s disease, was 3.5 times higher in patients with eosinophilic esophagitis (EoE).

Major finding: Compared with control individuals without EoE, patients with EoE were at a ~3.5-fold increased risk for IBD (adjusted hazard ratio [aHR] 3.56; 95% CI 1.79-7.11), particularly Crohn’s disease (aHR 3.39; 95% CI 1.2-9.60). When compared with siblings of patients with EoE, 12 patients with EoE were diagnosed with IBD later in life compared with 11 siblings, which corresponded to an aHR of 2.48 (95% CI 0.92-6.70).

Study details: Findings are from a nationwide cohort study including 1587 patients with histologically verified EoE and 7808 age- and sex-matched control individuals without EoE.

Disclosures: This study was funded by the Consortium of Eosinophilic Gastrointestinal Disease Researcher Training Program and Karolinska Institutet, Sweden. Some authors declared serving as consultants, advisors, or speakers for or receiving financial support, grants, or fees for lectures from Karolinska Institutet and other sources.

Source: Uchida AM et al. Eosinophilic esophagitis is associated with increased risk of later inflammatory bowel disease in a nationwide Swedish population cohort. United European Gastroenterol J. 2023 (Dec 7). doi: 10.1002/ueg2.12493

Key clinical point: The risk for inflammatory bowel diseases (IBD), particularly Crohn’s disease, was 3.5 times higher in patients with eosinophilic esophagitis (EoE).

Major finding: Compared with control individuals without EoE, patients with EoE were at a ~3.5-fold increased risk for IBD (adjusted hazard ratio [aHR] 3.56; 95% CI 1.79-7.11), particularly Crohn’s disease (aHR 3.39; 95% CI 1.2-9.60). When compared with siblings of patients with EoE, 12 patients with EoE were diagnosed with IBD later in life compared with 11 siblings, which corresponded to an aHR of 2.48 (95% CI 0.92-6.70).

Study details: Findings are from a nationwide cohort study including 1587 patients with histologically verified EoE and 7808 age- and sex-matched control individuals without EoE.

Disclosures: This study was funded by the Consortium of Eosinophilic Gastrointestinal Disease Researcher Training Program and Karolinska Institutet, Sweden. Some authors declared serving as consultants, advisors, or speakers for or receiving financial support, grants, or fees for lectures from Karolinska Institutet and other sources.

Source: Uchida AM et al. Eosinophilic esophagitis is associated with increased risk of later inflammatory bowel disease in a nationwide Swedish population cohort. United European Gastroenterol J. 2023 (Dec 7). doi: 10.1002/ueg2.12493

Key clinical point: Budesonide oral suspension (BOS) significantly improved most of the efficacy outcomes in adolescents with eosinophilic esophagitis (EoE) over 12 weeks.

Major finding: At week 12, a significantly higher number of adolescents receiving BOS vs placebo achieved histologic (≤6, ≤1, and <15 eosinophils/high-power field; all P < .001) and clinicopathologic (P = .003) responses. BOS vs placebo led to greater reductions in the EoE histology scoring system grade (P < .001) and total EoE endoscopic reference scores (P = .021). Treatment-emergent adverse events were mild or moderate in severity.

Study details: This post hoc analysis of pooled data from a phase 2 and a phase 3 study included 76 adolescents with EoE (age 11-17 years) who were randomly assigned to receive 2 mg BOS twice daily or placebo.

Disclosures: These studies were funded by Shire ViroPharma, Inc., a Takeda company, and Meritage Pharma, Inc. (now part of Shire). Some authors declared serving as consultants for or receiving research funding, etc., from Meritage, Shire, and others. Four authors declared being employees and stockholders of Takeda.

Source: Mukkada VA et al. Pooled phase 2 and 3 efficacy and safety data on budesonide oral suspension in adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2023;77(6):760-768 (Sep 18). doi: 10.1097/MPG.0000000000003948

Key clinical point: Budesonide oral suspension (BOS) significantly improved most of the efficacy outcomes in adolescents with eosinophilic esophagitis (EoE) over 12 weeks.

Major finding: At week 12, a significantly higher number of adolescents receiving BOS vs placebo achieved histologic (≤6, ≤1, and <15 eosinophils/high-power field; all P < .001) and clinicopathologic (P = .003) responses. BOS vs placebo led to greater reductions in the EoE histology scoring system grade (P < .001) and total EoE endoscopic reference scores (P = .021). Treatment-emergent adverse events were mild or moderate in severity.

Study details: This post hoc analysis of pooled data from a phase 2 and a phase 3 study included 76 adolescents with EoE (age 11-17 years) who were randomly assigned to receive 2 mg BOS twice daily or placebo.

Disclosures: These studies were funded by Shire ViroPharma, Inc., a Takeda company, and Meritage Pharma, Inc. (now part of Shire). Some authors declared serving as consultants for or receiving research funding, etc., from Meritage, Shire, and others. Four authors declared being employees and stockholders of Takeda.

Source: Mukkada VA et al. Pooled phase 2 and 3 efficacy and safety data on budesonide oral suspension in adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2023;77(6):760-768 (Sep 18). doi: 10.1097/MPG.0000000000003948

Key clinical point: Budesonide oral suspension (BOS) significantly improved most of the efficacy outcomes in adolescents with eosinophilic esophagitis (EoE) over 12 weeks.

Major finding: At week 12, a significantly higher number of adolescents receiving BOS vs placebo achieved histologic (≤6, ≤1, and <15 eosinophils/high-power field; all P < .001) and clinicopathologic (P = .003) responses. BOS vs placebo led to greater reductions in the EoE histology scoring system grade (P < .001) and total EoE endoscopic reference scores (P = .021). Treatment-emergent adverse events were mild or moderate in severity.

Study details: This post hoc analysis of pooled data from a phase 2 and a phase 3 study included 76 adolescents with EoE (age 11-17 years) who were randomly assigned to receive 2 mg BOS twice daily or placebo.

Disclosures: These studies were funded by Shire ViroPharma, Inc., a Takeda company, and Meritage Pharma, Inc. (now part of Shire). Some authors declared serving as consultants for or receiving research funding, etc., from Meritage, Shire, and others. Four authors declared being employees and stockholders of Takeda.

Source: Mukkada VA et al. Pooled phase 2 and 3 efficacy and safety data on budesonide oral suspension in adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2023;77(6):760-768 (Sep 18). doi: 10.1097/MPG.0000000000003948

Key clinical point: In adolescents and adults with eosinophilic esophagitis (EoE), 300 mg dupilumab per week was effective and well-tolerated regardless of prior exposure to swallowed topical corticosteroids (STC).

Major finding: At week 24, a significantly higher proportion of patients receiving dupilumab vs placebo with (>50% vs ≤5%; P < .0001) or without (>45% vs ≤25%; P < .05) prior exposure to STC achieved a peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high-power field, with the improvements being maintained till week 52. No new adverse events were reported.

Study details: This sub-group analysis of the phase 3 LIBERTY EoE TREET study included 321 patients with EoE who were randomly assigned to receive dupilumab or placebo for 24 weeks, after which 304 patients received dupilumab for 28 weeks additionally.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Seven authors declared being employees or stockholders of Regeneron Pharmaceuticals or Sanofi. The other authors declared ties with various sources, including Sanofi and Regeneron.

Source: Bredenoord AJ et al. Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis: A subgroup analysis of the phase 3 LIBERTY EoE TREET study. Gut. 2023 (Nov 27). doi: 10.1136/gutjnl-2023-330220

Key clinical point: In adolescents and adults with eosinophilic esophagitis (EoE), 300 mg dupilumab per week was effective and well-tolerated regardless of prior exposure to swallowed topical corticosteroids (STC).

Major finding: At week 24, a significantly higher proportion of patients receiving dupilumab vs placebo with (>50% vs ≤5%; P < .0001) or without (>45% vs ≤25%; P < .05) prior exposure to STC achieved a peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high-power field, with the improvements being maintained till week 52. No new adverse events were reported.

Study details: This sub-group analysis of the phase 3 LIBERTY EoE TREET study included 321 patients with EoE who were randomly assigned to receive dupilumab or placebo for 24 weeks, after which 304 patients received dupilumab for 28 weeks additionally.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Seven authors declared being employees or stockholders of Regeneron Pharmaceuticals or Sanofi. The other authors declared ties with various sources, including Sanofi and Regeneron.

Source: Bredenoord AJ et al. Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis: A subgroup analysis of the phase 3 LIBERTY EoE TREET study. Gut. 2023 (Nov 27). doi: 10.1136/gutjnl-2023-330220

Key clinical point: In adolescents and adults with eosinophilic esophagitis (EoE), 300 mg dupilumab per week was effective and well-tolerated regardless of prior exposure to swallowed topical corticosteroids (STC).

Major finding: At week 24, a significantly higher proportion of patients receiving dupilumab vs placebo with (>50% vs ≤5%; P < .0001) or without (>45% vs ≤25%; P < .05) prior exposure to STC achieved a peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high-power field, with the improvements being maintained till week 52. No new adverse events were reported.

Study details: This sub-group analysis of the phase 3 LIBERTY EoE TREET study included 321 patients with EoE who were randomly assigned to receive dupilumab or placebo for 24 weeks, after which 304 patients received dupilumab for 28 weeks additionally.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Seven authors declared being employees or stockholders of Regeneron Pharmaceuticals or Sanofi. The other authors declared ties with various sources, including Sanofi and Regeneron.

Source: Bredenoord AJ et al. Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis: A subgroup analysis of the phase 3 LIBERTY EoE TREET study. Gut. 2023 (Nov 27). doi: 10.1136/gutjnl-2023-330220

Key clinical point: The use of antibiotics and acid-suppressants during the prenatal period and infancy increased the risk of developing eosinophilic esophagitis (EoE) later in life.

Major finding: The risk for EoE increased by 50% in offsprings who were administered antibiotics during the prenatal period (adjusted odds ratio [aOR] 1.5; 95% CI 1.2-1.9); moreover, the administration of antibiotics (aOR 1.4; 95% CI 1.1-1.7) and acid-suppressants (aOR 15.9; 95% CI 9.1-27.7) in infancy was significantly associated with an increased risk for EoE.

Study details: Findings are from a case-control study including 392 children with EoE and 3637 age- and sex-matched control individuals without EoE.

Disclosures: This study was supported by a grant from the US National Institutes of Allergy and Infectious Diseases. Some authors declared receiving grants, consulting fees, or funding from various sources.

Source: Jensen ET et al. Maternal and infant antibiotic and acid suppressant use and risk of eosinophilic esophagitis. JAMA Pediatr. 2023;177(12):1285-1293 (Oct 30). doi: 10.1001/jamapediatrics.2023.4609

Key clinical point: The use of antibiotics and acid-suppressants during the prenatal period and infancy increased the risk of developing eosinophilic esophagitis (EoE) later in life.

Major finding: The risk for EoE increased by 50% in offsprings who were administered antibiotics during the prenatal period (adjusted odds ratio [aOR] 1.5; 95% CI 1.2-1.9); moreover, the administration of antibiotics (aOR 1.4; 95% CI 1.1-1.7) and acid-suppressants (aOR 15.9; 95% CI 9.1-27.7) in infancy was significantly associated with an increased risk for EoE.

Study details: Findings are from a case-control study including 392 children with EoE and 3637 age- and sex-matched control individuals without EoE.

Disclosures: This study was supported by a grant from the US National Institutes of Allergy and Infectious Diseases. Some authors declared receiving grants, consulting fees, or funding from various sources.

Source: Jensen ET et al. Maternal and infant antibiotic and acid suppressant use and risk of eosinophilic esophagitis. JAMA Pediatr. 2023;177(12):1285-1293 (Oct 30). doi: 10.1001/jamapediatrics.2023.4609

Key clinical point: The use of antibiotics and acid-suppressants during the prenatal period and infancy increased the risk of developing eosinophilic esophagitis (EoE) later in life.

Major finding: The risk for EoE increased by 50% in offsprings who were administered antibiotics during the prenatal period (adjusted odds ratio [aOR] 1.5; 95% CI 1.2-1.9); moreover, the administration of antibiotics (aOR 1.4; 95% CI 1.1-1.7) and acid-suppressants (aOR 15.9; 95% CI 9.1-27.7) in infancy was significantly associated with an increased risk for EoE.

Study details: Findings are from a case-control study including 392 children with EoE and 3637 age- and sex-matched control individuals without EoE.

Disclosures: This study was supported by a grant from the US National Institutes of Allergy and Infectious Diseases. Some authors declared receiving grants, consulting fees, or funding from various sources.

Source: Jensen ET et al. Maternal and infant antibiotic and acid suppressant use and risk of eosinophilic esophagitis. JAMA Pediatr. 2023;177(12):1285-1293 (Oct 30). doi: 10.1001/jamapediatrics.2023.4609

Antireflux surgery may be no more effective than antireflux medication for reducing risk of esophageal adenocarcinoma (EAC) among patients with Barrett’s esophagus, according to a Nordic retrospective study.

Risk of EAC was higher among patients who underwent surgery, and risk appeared to increase over time, suggesting that postoperative patients should continue to participate in surveillance programs, reported lead author Jesper Lagergren, MD, PhD, of the Karolinska Institutet, Stockholm, and colleagues.

Karolinska Institutet

“Antireflux surgery with fundoplication increases the ability of the gastroesophageal anatomic and physiological barrier to prevent reflux, and can thus prevent any carcinogenic gastric content from reaching the esophagus, including both acid and bile,” the investigators wrote in Gastroenterology, noting that surgery reduces esophageal acid exposure to a greater degree than medication. “Antireflux surgery may thus prevent esophageal adenocarcinoma better than antireflux medication.”

Three meta-analyses to date, however, have failed to provide consistent support for this hypothesis.

“Most of the studies included in these meta-analyses came from single centers, were of small sample size, examined only one treatment arm, and had a short or incomplete follow-up, and ... were hampered by heterogeneity among the included studies,” they noted.

For the present study, Dr. Lagergren and colleagues analyzed national registry data from 33,939 patients with Barrett’s esophagus in Denmark, Finland, Norway, and Sweden. Out of this group, 542 patients (1.6%) had undergone antireflux surgery, while the remainder were managed with antireflux medication.

In both groups, approximately two-thirds of the patients were men. The median age at enrollment was about a decade higher in the medication group (66 vs. 54 years), and this group also tended to have more comorbidities.

After a follow-up period as long as 32 years, the absolute rates of EAC were 1.3% and 2.6% in the medication and surgery groups, respectively. Multivariate analysis, with adjustments for sex, age, year, comorbidities, and age, revealed that postsurgical patients had a 90% increased risk of EAC (hazard ratio [HR], 1.9; 95% CI, 1.1-3.5), versus patients treated with antireflux medication alone.

The relatively higher risk of EAC appeared to increase over time, based on a nonsignificant hazard ratio of 1.8 during the 1- to 4-year follow-up period (HR, 1.8; 95% CI, 0.6-5.0), versus a significant, fourfold risk elevation during the 10- to 32-year follow-up period (HR, 4.4; 95% CI, 1.4-13.5).

“In this cohort of patients with Barrett’s esophagus, the risk of esophageal adenocarcinoma did not decrease after antireflux surgery compared with antireflux medication,” the investigators wrote. “Instead, the risk was increased throughout the follow-up among patients having undergone antireflux surgery.”

Dr. Lagergren and colleagues suggested that the reason for relatively higher cancer risk in the group that underwent surgery likely stems from early and prolonged acid exposure.

“[P]erforming antireflux surgery after years of GERD may be too late to enable a cancer-preventative effect, and most of the patients first diagnosed with Barrett’s esophagus reported a history of many years of GERD symptoms,” they wrote, suggesting that carcinogenic processes had already been set in motion by the time surgery was performed.

“[P]atients with Barrett’s esophagus who undergo antireflux surgery remain at an increased risk of esophageal adenocarcinoma and should continue taking part in surveillance programs,” the investigators concluded.

The study was funded by the Swedish Cancer Society, Swedish Research Council, and Stockholm County Council. The investigators disclosed no conflicts of interest.

Antireflux surgery may be no more effective than antireflux medication for reducing risk of esophageal adenocarcinoma (EAC) among patients with Barrett’s esophagus, according to a Nordic retrospective study.

Risk of EAC was higher among patients who underwent surgery, and risk appeared to increase over time, suggesting that postoperative patients should continue to participate in surveillance programs, reported lead author Jesper Lagergren, MD, PhD, of the Karolinska Institutet, Stockholm, and colleagues.

Karolinska Institutet

“Antireflux surgery with fundoplication increases the ability of the gastroesophageal anatomic and physiological barrier to prevent reflux, and can thus prevent any carcinogenic gastric content from reaching the esophagus, including both acid and bile,” the investigators wrote in Gastroenterology, noting that surgery reduces esophageal acid exposure to a greater degree than medication. “Antireflux surgery may thus prevent esophageal adenocarcinoma better than antireflux medication.”

Three meta-analyses to date, however, have failed to provide consistent support for this hypothesis.

“Most of the studies included in these meta-analyses came from single centers, were of small sample size, examined only one treatment arm, and had a short or incomplete follow-up, and ... were hampered by heterogeneity among the included studies,” they noted.

For the present study, Dr. Lagergren and colleagues analyzed national registry data from 33,939 patients with Barrett’s esophagus in Denmark, Finland, Norway, and Sweden. Out of this group, 542 patients (1.6%) had undergone antireflux surgery, while the remainder were managed with antireflux medication.

In both groups, approximately two-thirds of the patients were men. The median age at enrollment was about a decade higher in the medication group (66 vs. 54 years), and this group also tended to have more comorbidities.

After a follow-up period as long as 32 years, the absolute rates of EAC were 1.3% and 2.6% in the medication and surgery groups, respectively. Multivariate analysis, with adjustments for sex, age, year, comorbidities, and age, revealed that postsurgical patients had a 90% increased risk of EAC (hazard ratio [HR], 1.9; 95% CI, 1.1-3.5), versus patients treated with antireflux medication alone.

The relatively higher risk of EAC appeared to increase over time, based on a nonsignificant hazard ratio of 1.8 during the 1- to 4-year follow-up period (HR, 1.8; 95% CI, 0.6-5.0), versus a significant, fourfold risk elevation during the 10- to 32-year follow-up period (HR, 4.4; 95% CI, 1.4-13.5).

“In this cohort of patients with Barrett’s esophagus, the risk of esophageal adenocarcinoma did not decrease after antireflux surgery compared with antireflux medication,” the investigators wrote. “Instead, the risk was increased throughout the follow-up among patients having undergone antireflux surgery.”

Dr. Lagergren and colleagues suggested that the reason for relatively higher cancer risk in the group that underwent surgery likely stems from early and prolonged acid exposure.

“[P]erforming antireflux surgery after years of GERD may be too late to enable a cancer-preventative effect, and most of the patients first diagnosed with Barrett’s esophagus reported a history of many years of GERD symptoms,” they wrote, suggesting that carcinogenic processes had already been set in motion by the time surgery was performed.

“[P]atients with Barrett’s esophagus who undergo antireflux surgery remain at an increased risk of esophageal adenocarcinoma and should continue taking part in surveillance programs,” the investigators concluded.

The study was funded by the Swedish Cancer Society, Swedish Research Council, and Stockholm County Council. The investigators disclosed no conflicts of interest.

Antireflux surgery may be no more effective than antireflux medication for reducing risk of esophageal adenocarcinoma (EAC) among patients with Barrett’s esophagus, according to a Nordic retrospective study.

Risk of EAC was higher among patients who underwent surgery, and risk appeared to increase over time, suggesting that postoperative patients should continue to participate in surveillance programs, reported lead author Jesper Lagergren, MD, PhD, of the Karolinska Institutet, Stockholm, and colleagues.

Karolinska Institutet

“Antireflux surgery with fundoplication increases the ability of the gastroesophageal anatomic and physiological barrier to prevent reflux, and can thus prevent any carcinogenic gastric content from reaching the esophagus, including both acid and bile,” the investigators wrote in Gastroenterology, noting that surgery reduces esophageal acid exposure to a greater degree than medication. “Antireflux surgery may thus prevent esophageal adenocarcinoma better than antireflux medication.”

Three meta-analyses to date, however, have failed to provide consistent support for this hypothesis.

“Most of the studies included in these meta-analyses came from single centers, were of small sample size, examined only one treatment arm, and had a short or incomplete follow-up, and ... were hampered by heterogeneity among the included studies,” they noted.

For the present study, Dr. Lagergren and colleagues analyzed national registry data from 33,939 patients with Barrett’s esophagus in Denmark, Finland, Norway, and Sweden. Out of this group, 542 patients (1.6%) had undergone antireflux surgery, while the remainder were managed with antireflux medication.

In both groups, approximately two-thirds of the patients were men. The median age at enrollment was about a decade higher in the medication group (66 vs. 54 years), and this group also tended to have more comorbidities.

After a follow-up period as long as 32 years, the absolute rates of EAC were 1.3% and 2.6% in the medication and surgery groups, respectively. Multivariate analysis, with adjustments for sex, age, year, comorbidities, and age, revealed that postsurgical patients had a 90% increased risk of EAC (hazard ratio [HR], 1.9; 95% CI, 1.1-3.5), versus patients treated with antireflux medication alone.

The relatively higher risk of EAC appeared to increase over time, based on a nonsignificant hazard ratio of 1.8 during the 1- to 4-year follow-up period (HR, 1.8; 95% CI, 0.6-5.0), versus a significant, fourfold risk elevation during the 10- to 32-year follow-up period (HR, 4.4; 95% CI, 1.4-13.5).

“In this cohort of patients with Barrett’s esophagus, the risk of esophageal adenocarcinoma did not decrease after antireflux surgery compared with antireflux medication,” the investigators wrote. “Instead, the risk was increased throughout the follow-up among patients having undergone antireflux surgery.”

Dr. Lagergren and colleagues suggested that the reason for relatively higher cancer risk in the group that underwent surgery likely stems from early and prolonged acid exposure.

“[P]erforming antireflux surgery after years of GERD may be too late to enable a cancer-preventative effect, and most of the patients first diagnosed with Barrett’s esophagus reported a history of many years of GERD symptoms,” they wrote, suggesting that carcinogenic processes had already been set in motion by the time surgery was performed.

“[P]atients with Barrett’s esophagus who undergo antireflux surgery remain at an increased risk of esophageal adenocarcinoma and should continue taking part in surveillance programs,” the investigators concluded.

The study was funded by the Swedish Cancer Society, Swedish Research Council, and Stockholm County Council. The investigators disclosed no conflicts of interest.

Use of fluticasone and budesonide for eosinophilic esophagitis during pregnancy had no significant adverse effect on maternal or fetal outcomes, according to new research presented at the annual meeting of the American College of Gastroenterology.

“Currently, there are no specific recommendations about the safe use of steroids in pregnant women with eosinophilic esophagitis (EoE), Julton Tomanguillo Chumbe, MD, said in an interview. “Our recommendations about the use of steroids among this population are based on the safety data extrapolated mainly from pregnant women with asthma.”

West Virginia University

In the study, Dr. Chumbe, an internal medicine resident at Charleston Area Medical Center, West Virginia University, Charleston, and colleagues identified pregnant patients aged 18 years and older with a diagnosis of EoE between January 2011 and December 2022 through the TriNetx Global Collaborative Network, which includes 101 health care organizations in 14 countries. The study population consisted of 1,263 individuals.

The researchers used propensity score matching (PSM) to compare the rates of spontaneous abortion, placenta previa, preeclampsia, premature delivery, HELLP syndrome, eclampsia, hyperemesis gravidarum, and major congenital abnormalities between women with EoE who did and did not use steroids during pregnancy. The PSM cohorts included 268 women in each group.

Overall, pregnant women who used steroids were not significantly more likely than were those who did not use steroids to experience spontaneous abortion (3.73% vs. 4.85%, P = .52). Rates of placenta previa, preeclampsia, premature delivery, HELLP syndrome, and hyperemesis gravidarum were equal between the groups (3.73% vs. 3.73%, P = 1.00 for all). No cases of eclampsia occurred in the steroid group, compared with a 3.73% rate in women who did not use steroids.

Incidence of major congenital abnormalities including but not limited to malformations of the eye, ear, face, neck, skull and face bones, and of the circulatory, respiratory, and digestive systems, were similar between the steroid and no steroid groups (7.09% vs. 8.20%, P = .62)

Dr. Chumbe said he was not surprised by the findings, given the robust data about the safe use of steroids in pregnant women with asthma, in terms of pregnancy outcomes and fetal outcomes.

“The findings of this study provide reassurance that the use of steroids in pregnant patients with eosinophilic esophagitis is not significantly associated with an increased risk of worse maternal or fetal outcomes,” he said. “During pregnancy, some patients may discontinue treatment due to safety concerns. However, this study suggests that this may not be necessary.” Consequently, patients can maintain EoE management while reducing the risk of complications.

Looking ahead, “it will be important to have some data about the safe use of dupilumab during pregnancy in patients with eosinophilic esophagitis,” he said.
 

Pregnant patients can maintain EoE management

“This study is able to address an important concern that many patients have regarding the safety of steroid therapy for EoE, particularly during pregnancy,” said Anita Afzali, MD, MPH, AGAF, a gastroenterologist specializing in inflammatory bowel disease and executive vice chair of internal medicine at the University of Cincinnati. “As EoE impacts over 40% of women, most who are in childbearing age, it is important to review the safety of treatment and management of EoE so a mother does not have to choose between EoE management and pregnancy.”

The results from this study were certainly reassuring, though not surprising, Dr. Afzali said. “Previously, the safety profile of steroids during pregnancy was mostly extrapolated from asthma, and other diseases such as inflammatory bowel disease. The results from this study confirm that there are no significant associations with adverse maternal or birth outcomes among women with EoE treated with steroids during pregnancy,” she said.

The study has some limitations, including the retrospective design and potential for selection bias, Dr. Afzali noted. “Further research is needed for the evaluation of newer therapies in the pipeline for treatment of EoE and its safety profile with pregnancy,” she said.

However, “sharing this information in clinical practice “will allow our patients to feel comfortable with continuation of appropriate steroid therapy for treatment and management of their EoE, without having to choose between family planning or pregnancy and EoE care management,” Dr. Afzali said.

The study received no outside funding. Dr. Chumbe an Dr. Afzali indicated having no relevant financial conflicts to disclose.

Use of fluticasone and budesonide for eosinophilic esophagitis during pregnancy had no significant adverse effect on maternal or fetal outcomes, according to new research presented at the annual meeting of the American College of Gastroenterology.

“Currently, there are no specific recommendations about the safe use of steroids in pregnant women with eosinophilic esophagitis (EoE), Julton Tomanguillo Chumbe, MD, said in an interview. “Our recommendations about the use of steroids among this population are based on the safety data extrapolated mainly from pregnant women with asthma.”

West Virginia University

In the study, Dr. Chumbe, an internal medicine resident at Charleston Area Medical Center, West Virginia University, Charleston, and colleagues identified pregnant patients aged 18 years and older with a diagnosis of EoE between January 2011 and December 2022 through the TriNetx Global Collaborative Network, which includes 101 health care organizations in 14 countries. The study population consisted of 1,263 individuals.

The researchers used propensity score matching (PSM) to compare the rates of spontaneous abortion, placenta previa, preeclampsia, premature delivery, HELLP syndrome, eclampsia, hyperemesis gravidarum, and major congenital abnormalities between women with EoE who did and did not use steroids during pregnancy. The PSM cohorts included 268 women in each group.

Overall, pregnant women who used steroids were not significantly more likely than were those who did not use steroids to experience spontaneous abortion (3.73% vs. 4.85%, P = .52). Rates of placenta previa, preeclampsia, premature delivery, HELLP syndrome, and hyperemesis gravidarum were equal between the groups (3.73% vs. 3.73%, P = 1.00 for all). No cases of eclampsia occurred in the steroid group, compared with a 3.73% rate in women who did not use steroids.

Incidence of major congenital abnormalities including but not limited to malformations of the eye, ear, face, neck, skull and face bones, and of the circulatory, respiratory, and digestive systems, were similar between the steroid and no steroid groups (7.09% vs. 8.20%, P = .62)

Dr. Chumbe said he was not surprised by the findings, given the robust data about the safe use of steroids in pregnant women with asthma, in terms of pregnancy outcomes and fetal outcomes.

“The findings of this study provide reassurance that the use of steroids in pregnant patients with eosinophilic esophagitis is not significantly associated with an increased risk of worse maternal or fetal outcomes,” he said. “During pregnancy, some patients may discontinue treatment due to safety concerns. However, this study suggests that this may not be necessary.” Consequently, patients can maintain EoE management while reducing the risk of complications.

Looking ahead, “it will be important to have some data about the safe use of dupilumab during pregnancy in patients with eosinophilic esophagitis,” he said.
 

Pregnant patients can maintain EoE management

“This study is able to address an important concern that many patients have regarding the safety of steroid therapy for EoE, particularly during pregnancy,” said Anita Afzali, MD, MPH, AGAF, a gastroenterologist specializing in inflammatory bowel disease and executive vice chair of internal medicine at the University of Cincinnati. “As EoE impacts over 40% of women, most who are in childbearing age, it is important to review the safety of treatment and management of EoE so a mother does not have to choose between EoE management and pregnancy.”

The results from this study were certainly reassuring, though not surprising, Dr. Afzali said. “Previously, the safety profile of steroids during pregnancy was mostly extrapolated from asthma, and other diseases such as inflammatory bowel disease. The results from this study confirm that there are no significant associations with adverse maternal or birth outcomes among women with EoE treated with steroids during pregnancy,” she said.

The study has some limitations, including the retrospective design and potential for selection bias, Dr. Afzali noted. “Further research is needed for the evaluation of newer therapies in the pipeline for treatment of EoE and its safety profile with pregnancy,” she said.

However, “sharing this information in clinical practice “will allow our patients to feel comfortable with continuation of appropriate steroid therapy for treatment and management of their EoE, without having to choose between family planning or pregnancy and EoE care management,” Dr. Afzali said.

The study received no outside funding. Dr. Chumbe an Dr. Afzali indicated having no relevant financial conflicts to disclose.

Use of fluticasone and budesonide for eosinophilic esophagitis during pregnancy had no significant adverse effect on maternal or fetal outcomes, according to new research presented at the annual meeting of the American College of Gastroenterology.

“Currently, there are no specific recommendations about the safe use of steroids in pregnant women with eosinophilic esophagitis (EoE), Julton Tomanguillo Chumbe, MD, said in an interview. “Our recommendations about the use of steroids among this population are based on the safety data extrapolated mainly from pregnant women with asthma.”

West Virginia University

In the study, Dr. Chumbe, an internal medicine resident at Charleston Area Medical Center, West Virginia University, Charleston, and colleagues identified pregnant patients aged 18 years and older with a diagnosis of EoE between January 2011 and December 2022 through the TriNetx Global Collaborative Network, which includes 101 health care organizations in 14 countries. The study population consisted of 1,263 individuals.

The researchers used propensity score matching (PSM) to compare the rates of spontaneous abortion, placenta previa, preeclampsia, premature delivery, HELLP syndrome, eclampsia, hyperemesis gravidarum, and major congenital abnormalities between women with EoE who did and did not use steroids during pregnancy. The PSM cohorts included 268 women in each group.

Overall, pregnant women who used steroids were not significantly more likely than were those who did not use steroids to experience spontaneous abortion (3.73% vs. 4.85%, P = .52). Rates of placenta previa, preeclampsia, premature delivery, HELLP syndrome, and hyperemesis gravidarum were equal between the groups (3.73% vs. 3.73%, P = 1.00 for all). No cases of eclampsia occurred in the steroid group, compared with a 3.73% rate in women who did not use steroids.

Incidence of major congenital abnormalities including but not limited to malformations of the eye, ear, face, neck, skull and face bones, and of the circulatory, respiratory, and digestive systems, were similar between the steroid and no steroid groups (7.09% vs. 8.20%, P = .62)

Dr. Chumbe said he was not surprised by the findings, given the robust data about the safe use of steroids in pregnant women with asthma, in terms of pregnancy outcomes and fetal outcomes.

“The findings of this study provide reassurance that the use of steroids in pregnant patients with eosinophilic esophagitis is not significantly associated with an increased risk of worse maternal or fetal outcomes,” he said. “During pregnancy, some patients may discontinue treatment due to safety concerns. However, this study suggests that this may not be necessary.” Consequently, patients can maintain EoE management while reducing the risk of complications.

Looking ahead, “it will be important to have some data about the safe use of dupilumab during pregnancy in patients with eosinophilic esophagitis,” he said.
 

Pregnant patients can maintain EoE management

“This study is able to address an important concern that many patients have regarding the safety of steroid therapy for EoE, particularly during pregnancy,” said Anita Afzali, MD, MPH, AGAF, a gastroenterologist specializing in inflammatory bowel disease and executive vice chair of internal medicine at the University of Cincinnati. “As EoE impacts over 40% of women, most who are in childbearing age, it is important to review the safety of treatment and management of EoE so a mother does not have to choose between EoE management and pregnancy.”

The results from this study were certainly reassuring, though not surprising, Dr. Afzali said. “Previously, the safety profile of steroids during pregnancy was mostly extrapolated from asthma, and other diseases such as inflammatory bowel disease. The results from this study confirm that there are no significant associations with adverse maternal or birth outcomes among women with EoE treated with steroids during pregnancy,” she said.

The study has some limitations, including the retrospective design and potential for selection bias, Dr. Afzali noted. “Further research is needed for the evaluation of newer therapies in the pipeline for treatment of EoE and its safety profile with pregnancy,” she said.

However, “sharing this information in clinical practice “will allow our patients to feel comfortable with continuation of appropriate steroid therapy for treatment and management of their EoE, without having to choose between family planning or pregnancy and EoE care management,” Dr. Afzali said.

The study received no outside funding. Dr. Chumbe an Dr. Afzali indicated having no relevant financial conflicts to disclose.

The Food and Drug Administration has approved vonoprazan 10-mg and 20-mg tablets (Voquezna, Phathom Pharmaceuticals) for the healing and maintenance of all grades of erosive esophagitis, also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.

Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than do proton pump inhibitors (PPIs) and is seen as a potential alternative.

Olivier Le Moal/Getty Images

The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.

The randomized, double-blind, multicenter study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.

Vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs. 85% for lansoprazole.

In addition, vonoprazan showed superior rates of healing in patients with moderate to severe disease (LA Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.

In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs. 72%) and in the subset of patients with moderate to severe erosive GERD (75% vs. 61%).

Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥ 2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.

The most common AEs in the maintenance phase (≥ 3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.

“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” Colin W. Howden, MD, professor emeritus, University of Tennessee, Memphis, said in the news release.

Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis,” Dr. Howden added.

Vonoprazan is expected to be available in the United States in December.

The FDA also recently approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.

In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the postapproval supplement for H. pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.

Dr. Howden is a former editor-in-chief of GI&Hepatology News. A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved vonoprazan 10-mg and 20-mg tablets (Voquezna, Phathom Pharmaceuticals) for the healing and maintenance of all grades of erosive esophagitis, also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.

Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than do proton pump inhibitors (PPIs) and is seen as a potential alternative.

Olivier Le Moal/Getty Images

The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.

The randomized, double-blind, multicenter study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.

Vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs. 85% for lansoprazole.

In addition, vonoprazan showed superior rates of healing in patients with moderate to severe disease (LA Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.

In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs. 72%) and in the subset of patients with moderate to severe erosive GERD (75% vs. 61%).

Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥ 2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.

The most common AEs in the maintenance phase (≥ 3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.

“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” Colin W. Howden, MD, professor emeritus, University of Tennessee, Memphis, said in the news release.

Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis,” Dr. Howden added.

Vonoprazan is expected to be available in the United States in December.

The FDA also recently approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.

In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the postapproval supplement for H. pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.

Dr. Howden is a former editor-in-chief of GI&Hepatology News. A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved vonoprazan 10-mg and 20-mg tablets (Voquezna, Phathom Pharmaceuticals) for the healing and maintenance of all grades of erosive esophagitis, also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.

Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than do proton pump inhibitors (PPIs) and is seen as a potential alternative.

Olivier Le Moal/Getty Images

The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.

The randomized, double-blind, multicenter study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.

Vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs. 85% for lansoprazole.

In addition, vonoprazan showed superior rates of healing in patients with moderate to severe disease (LA Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.

In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs. 72%) and in the subset of patients with moderate to severe erosive GERD (75% vs. 61%).

Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥ 2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.

The most common AEs in the maintenance phase (≥ 3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.

“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” Colin W. Howden, MD, professor emeritus, University of Tennessee, Memphis, said in the news release.

Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis,” Dr. Howden added.

Vonoprazan is expected to be available in the United States in December.

The FDA also recently approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.

In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the postapproval supplement for H. pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.

Dr. Howden is a former editor-in-chief of GI&Hepatology News. A version of this article appeared on Medscape.com.