Dupixent improved esophageal function, reduced structural damage, and achieved high histologic remission rates in adults with eosinophilic esophagitis in the Phase 4 REMODEL trial.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
Regeneron Pharmaceuticals and Sanofi reported results from the Phase 4 REMODEL trial showing that Dupixent (dupilumab) significantly improved esophageal function and reduced structural damage in adults with eosinophilic esophagitis (EoE) at Week 24 compared with placebo, with findings presented at Digestive Disease Week 2026.
Eosinophilic esophagitis is a chronic, progressive disease driven by type 2 inflammation that leads to fibrosis, esophageal narrowing, and food impaction, often requiring mechanical dilation in advanced cases. The randomized, placebo-controlled Phase 4 study (NCT06101095) evaluated weekly 300 mg dupilumab in 69 adults with active disease, demonstrating consistent improvements across functional, structural, and histologic endpoints.
At Week 24, dupilumab improved esophageal distensibility by 1.28 mm, representing a 9% increase from baseline, while the placebo group showed a 0.01 mm decrease. Structural changes assessed by EREFS showed a 4.89-point reduction with dupilumab compared to a 0.07-point increase with placebo.
Histologic analysis using the Eosinophilic Esophagitis Histology Scoring System (EoE-HSS) demonstrated reductions in disease severity (−0.89 vs −0.18) and disease extent (−0.80 vs −0.14). These changes translated into meaningful clinical outcomes, with 59% of patients achieving histologic remission (≤6 eos/hpf) and 78% falling below the diagnostic threshold for EoE (<15 eos/hpf), compared with 4% in the placebo group.
Dupilumab, a monoclonal antibody that inhibits IL-4 and IL-13 signaling, targets the underlying inflammatory pathway and may modify disease progression by improving both esophageal function and tissue structure within six months.
According to Evan S. Dellon, M.D., M.P.H., Professor of Gastroenterology and Hepatology at the University of North Carolina School of Medicine and lead author, “Untreated disease often leads to esophageal narrowing and recurrent food impaction requiring dilation, and these findings suggest that targeting inflammation can provide functional improvements comparable to mechanical intervention.”
Safety findings were consistent with the established profile of dupilumab. Adverse events were reported in 62% of patients receiving dupilumab and 48% of those receiving placebo, with the most common events being injection site pain and headache (9% each vs 4% with placebo). No serious adverse events were reported in either group.
Dupilumab is approved in multiple regions for eosinophilic esophagitis and other type 2 inflammatory diseases, including Chronic Spontaneous Urticaria, atopic dermatitis, asthma, bullous pemphigoid and chronic rhinosinusitis with nasal polyps, and continues to be evaluated in additional indications as part of the ongoing Regeneron–Sanofi collaboration involving more than 60 clinical trials and over 12,000 patients.
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About the Writer
Fariha Sameen, PharmD, is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.