Evan S. Dellon
ORLANDO — Dupixent, a fully human monoclonal antibody approved for the treatment of atopic dermatitis, improved symptoms and objective measures of disease in patients with eosinophilic esophagitis, according to late-breaking research presented at the World Congress of Gastroenterology at ACG 2017.
Dupixent (dupilumab, Sanofi/Regeneron) “significantly improved dysphagia, esophageal eosinophil counts, endoscopic features, histology and esophageal distensibility in adults with active EoE compared with placebo,” Evan S. Dellon, MD, associate professor of medicine and epidemiology at the Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, Chapel Hill, said during his presentation.
Dupilumab inhibits signaling of IL-4 and IL-13, which are key drivers of type 2-mediated inflammation, and has demonstrated safety and efficacy in other type 2 immune diseases like uncontrolled persistent asthma and severe chronic sinusitis with nasal polyps, he noted.
Dellon and colleagues performed a double-blind phase 2 trial in which they randomly assigned 47 adults with moderate-to-severe active EoE to receive 300 mg dupilumab (600 mg day one loading dose) by subcutaneous injection once per week or placebo for 12 weeks.
The study achieved its primary endpoint as the study drug significantly improved dysphasia vs. placebo by week 10 as measured by Straumann Dysphagia Instrument scores (–3 vs. –1.3; P = .0304).
Eosinophilic Esophagitis Activity Index (EEsAI) scores also decreased at week 10 with dupilumab vs. placebo, but this did not reach statistical significance (34.6% vs. 11.3%).
Further, the study drug significantly reduced peak eosinophil count (eosinophils/high-power field) vs. placebo (91.8% vs. 15.1%; P < .0001) at week 12, and significantly reduced a modified EoE Endoscopic Reference Score vs. placebo (1.9 vs 0.3; P = .0006) at week 12.
Finally, the study drug significantly improved total EoE Histological Scoring System scores and distensibility plateau vs. placebo at week 12 (both P < .001).
The drug was generally well-tolerated, but injection-site erythema (34.8% vs. 8.3%) and nasopharyngitis (17.4% vs. 4.2%) occurred more frequently in the dupilumab group.
“These results confirm the critical role of IL-4 and IL-13 in EoE and support further evaluation of dupilumab,” Dellon concluded. – by Adam Leitenberger
Hirano I, et al. Abstract 20. Presented at: World Congress of Gastroenterology at American College of Gastroenterology Annual Scientific Meeting; Oct. 13-18, 2017; Orlando, FL.
Disclosures: Dellon reports financial relationships with Regeneron, Alivio, Adare, Banner, Enumeral, GlaxoSmithKline, Receptos/Celgene, Shire, Meritage, Miraca and Nutricia. Please see the full study for a list of all other authors’ relevant financial disclosures.