Dupixent improves eosinophilic esophagitis symptoms

Dupixent improved disease-specific, health-related quality of life and reduced symptoms in adolescents and adults with eosinophilic esophagitis, according to data from the American Academy of Allergy, Asthma and Immunology Annual Meeting.

“There are currently no FDA-approved therapies for the treatment of eosinophilic esophagitis,” Evan Dellon, MD, PhD, professor of medicine and adjunct professor of epidemiology at the University of North Carolina School of Medicine in Chapel Hill, told Healio Primary Care. “Treatment options are limited and, in many cases, there is limited evidence to support their use.”

The current analysis is the first part of a randomized, placebo-controlled, three-part phase 3 study, during which Dellon and colleagues evaluated the effectiveness of treatment with 300 mg Dupixent (dupilumab, Regeneron) vs. placebo in patients with eosinophilic esophagitis (EoE).

The researchers assessed changes from baseline to week 24 in scores on the EoE Impact Questionnaire — which measures the social, emotional productivity and sleep-related impacts of EoE — with scores ranging from one to five. They also evaluated changes in scores on the EoE Symptom Frequency Questionnaire — which measures the frequency of EoE symptoms other than dysphagia, such as chest and stomach pain, heartburn, regurgitation and vomiting — with scores ranging from five to 25. In both questionnaires, higher scores demonstrated a greater EoE symptom burden.

A total of 81 patients with EoE aged 12 years or older were included in the study, with 42 patients randomly assigned to receive dupilumab and 39 patients assigned to receive placebo.

Dellon and colleagues determined that at week 24, the mean change in EoE Impact Questionnaire score from baseline in those who received dupilumab compared with placebo was -0.4 (95% CI, –0.6 to –0.1). For the EoE Symptom Frequency Questionnaire, the mean change in score from baseline to week 24 in those who received treatment compared with those who received placebo was –1.7 (95% CI, –2.9 to –0.5).

The researchers reported that, at week 24, 47.2% of patients who received dupilumab said their dysphagia was “very much better,” and just 5.6% said they did not experience a change in dysphagia. In patients treated with placebo, 42.9% reported that they did not experience a change in dysphagia.

Dupilumab was well tolerated, and the most comment adverse events were injection site reaction and nasopharyngitis, Dellon said during the presentation.

“Paired with the primary and secondary endpoints that were presented last year, these data show the potential impact that dupilumab treatment could have for patients with EoE aged 12 years and older,” Dellon said. “The results show that for these patients, [dupilumab] significantly reduced the burden of EoE symptoms — including those not related to swallowing trouble — and improved health-related quality of life, as reported by the patients themselves.”

References:

Dellon E, et al. Abstract 290. Presented at: AAAAI Annual Meeting; February 26-March 1, 2021. (Virtual)

PRNewswise. Dupixent® (dupilumab) Late-breaking Pivotal Data Showing Significant Improvement in Eosinophilic Esophagitis Signs and Symptoms Presented for the First Time at Scientific Meetings. https://www.prnewswire.com/news-releases/dupixent-dupilumab-late-breaking-pivotal-data-showing-significant-improvement-in-eosinophilic-esophagitis-signs-and-symptoms-presented-for-the-first-time-at-scientific-meetings-301159325.html. Accessed March 8, 2021.