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Войти в исследования The American journal of gastroenterology · 2026
Dupilumab Improves Esophageal Distensibility in EoE: 24-Week Results From the REMODEL Randomized Trial.
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Dellon Evan S, Carlson Dustin A, Greuter Thomas, Collins Margaret H, Lankarani Ali, Talreja Neetu, Ravi Karthik, Simões Neto Joaquim, Afif Waqqas, Gonsalves Nirmala P, Lynch Kristle L, Zaghloul Sherif, Cunoosamy Danen, Durrani Sandy R, Zhang Mei, Raphael Bram P, Angello James T, Radwan Amr, Almansa Cristina, Biedermann Luc
Аннотация
OBJECTIVES: Eosinophilic esophagitis (EoE) is a chronic, often progressive, type 2 inflammatory disease characterized by eosinophilic infiltration, and esophageal narrowing and dysfunction. This analysis presents 24-week outcomes from the phase 4 REMODEL trial, evaluating long-term esophageal distensibility in adults with EoE.
METHODS: Adult EoE patients were randomized 2:1 to dupilumab 300 mg once weekly or placebo. Patients were assessed overall and by low (<17 mm) and normal (≥17 mm) baseline distensibility plateau (DP) subgroups. Endpoints at week (W) 24 included: absolute change from baseline in esophageal DP diameter on endoluminal functional lumen imaging probe (primary), and changes from baseline in Endoscopic Reference Scores (EREFS) and EoE histology scoring system (EoEHSS) grade/stage scores. Safety was assessed.
RESULTS: Sixty-nine patients (46 dupilumab, 23 placebo) were randomized. Evaluable patients in the DP subgroups were: 30 low (19 dupilumab, 11 placebo) and 33 normal (22 dupilumab, 11 placebo) baseline DP. At W24 overall, dupilumab improved esophageal DP diameter vs placebo; least squares mean (LSM) (±SE) absolute change from baseline: +1.28 mm (0.29) and -0.01 mm (0.42); LSM difference: +1.30 mm (95% CI: 0.31, 2.29; P < 0.05). LSM difference vs placebo in the low DP subgroup was +2.21 mm (95% CI: 0.78, 3.63; nominal P = 0.0024). Overall LSM difference for dupilumab vs placebo was -4.96 (-6.06, -3.85) in EREFS, and -0.71 (-0.86, -0.57) and -0.65 (-0.80, -0.51) in EoEHSS grade and stage scores, respectively (all P < 0.0001). No new safety signals were identified.
CONCLUSION: Dupilumab significantly improved W24 esophageal distensibility outcomes, with greater improvements in the low baseline DP subgroup compared to the overall population. (ClinicalTrials.gov, number NCT06101095).
METHODS: Adult EoE patients were randomized 2:1 to dupilumab 300 mg once weekly or placebo. Patients were assessed overall and by low (<17 mm) and normal (≥17 mm) baseline distensibility plateau (DP) subgroups. Endpoints at week (W) 24 included: absolute change from baseline in esophageal DP diameter on endoluminal functional lumen imaging probe (primary), and changes from baseline in Endoscopic Reference Scores (EREFS) and EoE histology scoring system (EoEHSS) grade/stage scores. Safety was assessed.
RESULTS: Sixty-nine patients (46 dupilumab, 23 placebo) were randomized. Evaluable patients in the DP subgroups were: 30 low (19 dupilumab, 11 placebo) and 33 normal (22 dupilumab, 11 placebo) baseline DP. At W24 overall, dupilumab improved esophageal DP diameter vs placebo; least squares mean (LSM) (±SE) absolute change from baseline: +1.28 mm (0.29) and -0.01 mm (0.42); LSM difference: +1.30 mm (95% CI: 0.31, 2.29; P < 0.05). LSM difference vs placebo in the low DP subgroup was +2.21 mm (95% CI: 0.78, 3.63; nominal P = 0.0024). Overall LSM difference for dupilumab vs placebo was -4.96 (-6.06, -3.85) in EREFS, and -0.71 (-0.86, -0.57) and -0.65 (-0.80, -0.51) in EoEHSS grade and stage scores, respectively (all P < 0.0001). No new safety signals were identified.
CONCLUSION: Dupilumab significantly improved W24 esophageal distensibility outcomes, with greater improvements in the low baseline DP subgroup compared to the overall population. (ClinicalTrials.gov, number NCT06101095).