This article is part of Pulmonology Advisor‘s coverage of the ACAAI 2018 meeting, taking place in Seattle, Washington. Our staff will report on medical research related to allergy, asthma, and more conducted by experts in the field. Check back regularly for more news from ACAAI 2018.
SEATTLE — RPC4046, a humanized anti-interleukin 13 (IL-13) antibody, reduced eosinophilic esophagitis (EoE) symptoms and resulted in improvements in endoscopic features, according the results of a phase 2 study presented at the American College of Allergy, Asthma & Immunology 2018 Annual Scientific Meeting, held November 15-19, 2018, in Seattle.
“[IL-13] has been implicated in the pathogenesis of [EoE],” the researchers explained. “RPC4046 prevents binding of IL-13 to IL-13Rα1 and IL-13Rα2 receptors. This study evaluated efficacy and safety of 2 dose levels of RPC4046 compared to placebo.”
Patients with EoE were randomly assigned 1:1:1 in a double-blind fashion to 180 mg RPC4046 (n=31), 360 mg RPC4046 (n=34), or placebo (n=34). On day 1 of treatment, an intravenous dose was administered, followed by subcutaneous doses each week. Investigators obtained baseline and 16-week follow-up centrally read esophageal biopsies to determine changes in mean eosinophil count. Secondary end points included the changes from baseline in the Daily Symptom Diary and EoE Endoscopic Reference Score. In addition, the researchers evaluated the safety of treatment at follow-up.
Compared with placebo, there were significantly greater reductions in the mean esophageal eosinophil counts from baseline to 16-week follow-up in both RPC4046 dose groups (mean change, −4.4 [placebo] vs −94.8 [180 mg RPC4046] and −99.9 [360 mg RPC4046]). Common adverse events reported in >5% of participants were headache (14.7% [placebo], 16.1% [180 mg RPC4046], and 20.6% [360 mg RPC4046], respectively), upper respiratory tract infections (8.8% [placebo], 16.1% [180 mg RPC4046], 14.7% [360 mg RPC4046]), and arthralgia (0% [placebo], 12.9% [180 mg RPC4046], 5.9% [360 mg RPC4046]).
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Hirano I, Collins M, Assouline-Dayan Y, et al. A randomized, double-blind, placebo-controlled trial of anti-interleukin-13 monoclonal antibody RPC4046 in patients with eosinophilic esophagitis. Presented at: the Annual Scientific Meeting of the American College of Allergy, Asthma, and Immunology; November 15-19, 2018; Seattle, WA. Abstract A400.