Novel therapy improves disease features in EoE
Patients with eosinophilic esophagitis who received Dupixent experienced improvement in dysphagia, severity of histologic and endoscopic features, esophageal intraepithelial eosinophil count and esophageal distensibility, and started seeing improved symptoms and quality of life, according to study results.
Ikuo Hirano, MD, of the Northwestern University Feinberg School of Medicine, and colleagues wrote there is a need to add more options for the treatment of EoE, which is currently treated with elimination diets, proton pump inhibitors and esophageal dilation.
“These therapies can be limited by variable response rates, relapse after therapy cessation, and adverse effects on quality of life,” they wrote. “These potential limitations highlight the need for new treatments targeting key pathways driving EoE inflammation.”
Dupixent (dupilumab, Regeneron/Sanofi) is a monoclonal antibody against the interleukin 4 receptor that inhibits IL-4 and IL-13. Researchers sought to determine its efficacy and safety in patients with EoE as it is effective for the treatment of other allergic, atopic and type 2 diseases such as inflammation and immune response to food allergens.
Investigators performed a phase 2 study in 47 adults with active EoE, defined as two episodes of dysphagia per week with peak eosinophil density of 15 or more eosinophils per high-power field. They randomly assigned patients to receive a weekly subcutaneous injection of dupilumab (300 mg; n = 23) or placebo (n = 24) for 12 weeks. They assessed change in baseline to week 10 in Straumann dysphagia instrument patient-reported outcome (SDI-PRO), as well as histologic (peak eosinophil count, EoE histologic scores) and endoscopic features (endoscopic reference score), esophageal distensibility and safety.
At baseline, the mean SDI-SRO score was 6.4. Patients in the dupilumab group experienced a mean reduction of 3 points at week 10 compared with a mean reduction of 1.3 points in the placebo group (P = .0304).
At week 12 of the study, patients who received dupilumab experienced a reduction in eosinophil count by a mean of 86.8 eosinophils per HPF (107.1% reduction; P < .0001 vs. baseline), a 68.3% reduction in EoE histology scoring system score (P < .0001 vs. baseline) and reduction in endoscopic reference score of 1.6 (P = .0006 vs. baseline). Patients in the dupilumab group also experienced an increase in esophageal distensibility of 18% compared with baseline (P < .0001).
Researchers also found that dupilumab was generally well tolerated by patients. However, non-serious, injection-site erythema (35% vs. 8%) and nasopharyngitis (17% vs. 4%) occurred more commonly in the dupilumab group.
“Dupilumab is the first targeted biologic agent to improve dysphagia, histologic and endoscopic measures of disease, as well as esophageal function, and have an acceptable safety profile in adult patients with active EoE,” Hirano and colleagues wrote. “Further studies are required to determine the long-term efficacy and safety of dupilumab in the treatment of EoE.” – by Alex Young
Disclosure s: Hirano reports consulting for Adare, Allakos, Receptos/Celgene and Regeneron and receiving research funding from Adare, Allakos, Meritage, Receptos/Celgene and Regeneron. Please see the full study for all other authors’ relevant financial disclosures.