Dupixent bests placebo in clinical, histological outcomes in patients with EoE
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CHARLOTTE, N.C. — Dupilumab improved clinical, symptomatic, histologic and endoscopic outcomes among patients treated for eosinophilic esophagitis, according to study results presented at the ACG Annual Scientific Meeting.
“EoE is a chronic, progressive, type 2 inflammatory disease of the esophagus, leading to symptoms of esophageal dysfunction that can substantially affect quality of life. Some current treatment options lack specificity, present adherence challenges or may offer suboptimal long-term disease control,” Evan S. Dellon, MD, MPH, FACG, professor of medicine and adjunct professor of epidemiology in the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine, said. “Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for IL4 and IL13, key and central drivers of type 2 inflammation in EoE, and the medication was recently approved by the FDA.”
Following positive results from a phase 2 proof-of-concept study in which Dupixent (dupilumab, Sanofi/Regeneron Pharmaceuticals) improved histological and clinical outcomes in EoE, Dellon and colleagues aimed to compare the safety and efficacy of weekly dupilumab with placebo.
In the phase 3, randomized, LIBERTY-EoE-TREET study, patients received dupilumab 300 mg (n =122) or placebo (n = 118) weekly for 24 weeks. Studied outcomes included the proportion of patients who achieved peak eosinophil count ( 6/high-power field [hpf]), absolute and percent change in Dysphagia Symptom Questionnaire (DSQ) score, percent change in peak eosinophil count, absolute change in Histologic Scoring System (HSS) grade/stage score, Endoscopic Reference Score (EREFS) and the proportion of patients who achieved peak eosinophil count less than 15/hpf.
According to study results, patients dosed with weekly dupilumab 300 mg achieved greater peak eosinophil count ( 6/hpf; 59% vs. 5.9%), absolute change in DSQ score (–23.2 vs. –12.7) as well as percent change in DSQ (–65.5% vs. –38.2%), percent change in peak eosinophil count (–80.1% vs. 1.5%), proportion of patients who achieved less than 15 eosinophils per hpf (77% vs. 7.6%), absolute change in HSS grade (–0.82 vs. –0.1) as well as HSS stage scores (–0.79 vs. –0.09), and change in EREFS score (–3.95 vs. –0.41).
Dupilumab was “generally well-tolerated,” with the most common treatment-emergent adverse event being injection site reaction (19.7% vs. 17.9%).
“The pooled data from part A and part B of the three-part, phase 3 LIBERTY-EoE-TREET study indicate that weekly dupilumab 300 mg vs. placebo demonstrated statistically significant and clinically meaningful improvements in histologic, endoscopic and symptom outcomes in adults and adolescents with EoE,” Dellon concluded. “Overall, the safety was consistent with the known dupilumab safety profile and again, based on these data, dupilumab was recently approved by the FDA for the treatment of adults and adolescents aged 12 years and older and weighing 40 kg or more for EoE.”
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Dellon ES, et al. Abstract S387: Dupilumab improves clinical, symptomatic, histologic and endoscopic aspects of EoE up to 24 weeks: Pooled results from parts A and B of phase 3 LIBERTY-EoE-TREET. Presented at: ACG Annual Scientific Meeting; Oct. 21-26, 2022; Charlotte, N.C. (hybrid meeting).
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