*EMBARGOED All research presented at the ACG Annual Scientific Meeting is strictly embargoed until Monday, October 17, 2016 at 8:00 am EDT.
Oral 19 A Randomized, Double-Blind, Placebo-Controlled Trial of a Novel Recombinant, Humanized, Anti-Interleukin-13 Monoclonal Antibody (RPC4046) in Patients with Active Eosinophilic Esophagitis: Results of the HEROES Study
Author Insight from Evan S. Dellon, MD, MPH, University of North Carolina at Chapel Hill
What’s new here and important for clinicians?
This phase 2 randomized clinical trial studied adult patients with active eosinophilic esophagitis (EoE) and dysphagia symptoms with the primary objective of assessing if treatment of these patients with a monoclonal antibody (RPC4046) targeting IL-13 would have an effect on reducing esophageal eosinophil count. The study demonstrated that there was a statistically significant and clinically meaningful reduction in esophageal eosinophil count so the study met its primary endpoint. Other disease-relevant parameters of EoE such as the endoscopic appearance of the esophageal mucosa, and clinicians’ and patients’ perception of disease severity also substantially improved. Patient symptoms of dysphagia also tended to improve. The safety profile of RPC4046 appeared to be favorable, although the study was of short duration and limited in size, so more patients will need to be exposed for a longer duration to fully understand the safety profile of RPC4046. A number of therapies have previously been studied in EoE, and this represents one of the first trials to have positive results in this disease and supports the role of IL-13 in EoE. The findings will need to be confirmed in a larger study.
What do patients need to know?
The phase 2 trial results are encouraging. However, additional studies will need to be conducted to better understand the effects of anti-IL-13 therapy before it could be considered as a treatment option for patients with EoE.
Author Contact
Evan S. Dellon, MD, MPH, University of North Carolina, Chapel Hill
edellon@med.unc.edu
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