Guselkumab efficacy and safety in East Asian participants with moderately to severely active Crohn’s disease: subgroup analysis of the phase 3 GALAXI 2 and GALAXI 3 trials

Background/Aims: Guselkumab, a dual-acting interleukin-23p19 subunit inhibitor, demonstrated efficacy and safety in participants with moderately to severely active Crohn' s disease in the global phase 3 GALAXI 2 and 3 trials.We report a subgroup analysis in East Asian participants.Methods: GALAXI 2 and 3 (NCT03466411) are identical, 48-week treat-through trials.Participants were randomized 2:2:2:1 to guselkumab 200 mg IV every 4 weeks (q4w; 3), followed by 100 mg SC every 8 weeks (q8w) or 200 mg SC q4w; ustekinumab; or placebo.Placebo participants not in clinical response at week (W)12 received ustekinumab.Co-primary endpoints were the composite of clinical response at W12 and clinical remission at W48, and the composite of clinical response at W12 and endoscopic response at W48.This subgroup analysis included participants from China, Japan, South Korea, and Taiwan.Results: The East Asian subgroup included 192 participants.Rates of clinical response at W12 and clinical remission at W48 with guselkumab were 55.6% (100 mg SC q8w) and 51.0% (200 mg SC q4w) versus 3.1% with placebo.Rates of clinical response at W12 and endoscopic response at W48 with guselkumab were 44.4% (100 mg SC q8w) and 39.2% (200 mg SC q4w), versus 0% for placebo.Numerically higher proportions of guselkumab participants achieved clinical and endoscopic outcomes at W48 relative to ustekinumab.Adverse event rates were consistent with the global population.Conclusions: Efficacy of guselkumab in East Asian participants was consistent with that observed in the global GALAXI 2 and 3 population.The safety profile was favorable and consistent with previous reports.(Intest Res,