Yoshikazu Kinoshita, Shiro Oka, Kayoko Matsushima, Mikinori Kataoka, Tsuyoshi Sanuki, Yasuhiro Fujiwara, Katsuhiro Arai, Shuichi Midorikawa, Hirotsugu Hatai, Christina M Charriez, Sandra Zhang, Jie Li, Keigo Asano, Ichiro Nomura
At week 16, cendakimab significantly reduced mean peak gastrointestinal eosinophil counts versus placebo (least squares mean difference -223.2 eosinophils/high-power field; P=0.003), with numerical improvements across symptom domains. Histologic effects were maintained at week 48 and a favorable safety profile was observed.
INTRODUCTION: Eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD; EG/EoD) are rare, chronic inflammatory disorders lacking approved treatments.
METHODS: We report a randomized, double-blind, placebo-controlled phase 3 trial evaluating cendakimab, an anti-IL-13 monoclonal antibody, in 48 Japanese patients with EG/EoD.
RESULTS: At week 16, cendakimab significantly reduced mean peak gastrointestinal eosinophil counts versus placebo (least squares mean difference -223.2 eosinophils/high-power field; P=0.003), with numerical improvements across symptom domains. Histologic effects were maintained at week 48 and a favorable safety profile was observed.
DISCUSSION: These findings highlight IL-13 inhibition as a potential treatment strategy for EG/EoD.