Johnson & Johnson announced positive topline results from the pivotal Phase 3 GRAVITI investigational study of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn's disease. The study met both co-primary endpoints, achieving statistically significant and clinically meaningful outcomes for clinical removal at Week 12 as well as endoscopic response at Week 12. All remaining multiplicity-controlled secondary endpoints at Week 12, Week 24 and Week 48 were statistically significant compared to placebo.

GRAVITI adds to the robust results demonstrated in GALAXI 2 and GALAXI 3, the first-ever double-blind registrational head-to-head clinical trials to demonstrate superiority versus STELARA® (ustekinumab) in key endoscopic endpoints in Crohn's disease, which together show the potential of TREMFYA? to become the only IL-23 inhibitor to offer both SC or IV induction options. Safety data from GRAVITI were consistent with the well-characterized safety profile of TREMFYA® in its approved indications.

Results from the GRAVITI study are being prepared for presentation at upcoming medical meetings and will be shared with health authorities in planned submissions. A separate Johnson & Johnson study evaluating the efficacy and safety of TREMFYA® SC induction therapy in ulcerative colitis is ongoing.