EoE Module 10 References-Hirano et al Gastroenterology 2019 RPC4046 a monoclonal antibody against IL13 reduces histologic and endoscopic activity in patients with EoE

Hirano et al Gastroenterology 2019 RPC4046 a monoclonal antibody against IL13 reduces histologic and endoscopic activity in patients with EoE

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In a study aimed at evaluating RPC4046, a monoclonal antibody targeting IL13, for eosinophilic esophagitis (EoE), results showed significant reductions in both histologic and endoscopic features of the disease. Conducted as a double-blind, placebo-controlled, phase 2 clinical trial, 99 adults with active EoE were randomized to receive either 180 mg or 360 mg of RPC4046, or placebo, weekly for 16 weeks. The primary outcome was the change in mean esophageal eosinophil count, while secondary outcomes involved dysphagia symptom frequency and severity.<br /><br />At the end of the trial, both doses of RPC4046 significantly reduced mean esophageal eosinophil counts compared to placebo. Specifically, reductions were from 94.8 for the 180 mg group and 99.9 for the 360 mg group, in contrast to only 4.4 for the placebo group. Additionally, significant endoscopic and histologic improvements were observed in the 360 mg dose group, including improvements in the clinician's global assessment of disease severity.<br /><br />Despite these promising outcomes on esophageal inflammation, the improvement in dysphagia symptoms was not statistically significant, although a trend was noted in the 360 mg group. Safety assessments revealed adverse events were mostly mild and similar across all groups, with headache and upper respiratory tract infections being the most common.<br /><br />These findings underscore IL13’s role in EoE pathogenesis and highlight RPC4046’s potential as a targeted treatment option. The data suggest further investigation into RPC4046’s efficacy, particularly for patients who are steroid-refractory or those adverse to long-term corticosteroid use. Future studies may aim to better elucidate its impact on clinical symptoms of dysphagia over a broader and longer-term treatment period.<br /><br />Conclusively, RPC4046 shows promise in reducing key pathologic features of EoE while being well tolerated, warranting further research into its long-term benefits and optimization of dosage in symptom management.

Keywords

RPC4046

monoclonal antibody

IL13

eosinophilic esophagitis

phase 2 clinical trial

esophageal eosinophil count

dysphagia symptoms

endoscopic improvements

histologic improvements

safety assessments