Efficacy and safety of subcutaneous guselkumab in East Asian participants with moderately to severely active Crohn's disease: subgroup analysis of the Phase 3 GRAVITI study.

内容摘要

The GRAVITI (NCT05197049) study demonstrated efficacy and safety of guselkumab, a dual-acting interleukin- 23p19 subunit inhibitor, as subcutaneous (SC) induction and maintenance therapy in participants with moderate to severely active Crohn's disease (CD). We report post hoc subgroup analyses in East Asian participants. Seventy-one East Asian participants were randomized 1:1:1 to guselkumab 400 mg SC every 4 weeks (q4w) (x3) followed by 100 mg SC every 8 weeks (q8w) starting at Week 16 (n = 23), guselkumab 400 mg SC q4w (x3) followed by 200 mg SC q4w starting at Week 12 (n = 20), or placebo (n = 28) in the Phase 3 double-blind, placebo-controlled, treat-through GRAVITI study. From Week 16, placebo participants meeting rescue criteria were eligible for rescue treatment with guselkumab. Clinical remission at Week 12 and endoscopic response at Week 12 were co-primary endpoints, additional endpoints included Patient-Reported Outcome-2 remission (Week 12), clinical response (Week 12), clinical remission (Week 24 and Week 48), and endoscopic response (Week 48), and safety through Week 48. Greater proportions of East Asian participants receiving guselkumab 400 mg SC achieved clinical remission versus placebo (41.9% vs. 14.3%) and endoscopic response versus placebo (39.5% vs. 21.4%) at Week 12. At Week 48, greater proportions of participants in both guselkumab groups (100 mg SC q8w, 69.6%; 200 mg SC q4w, 60.0%) achieved clinical remission versus placebo (10.7%) and endoscopic response versus placebo (43.5%, 60.0%; vs. placebo 0.0%). The adverse event profile was generally consistent with the global population. Efficacy and safety results of SC guselkumab in East Asian participants with moderately to severely active CD reflect findings from the global study.