TREMFYA® (guselkumab) induction therapy administered either intravenously (GALAXI 2 and 3) or subcutaneously (GRAVITI) achieved the co-primary endpoints of clinical remissiona and endoscopic responseb at Week 12 compared to placebo.1,2,3 Guselkumab demonstrated statistically significant and clinically meaningful improvements in clinical remissiona and endoscopic responseb at Week 48 compared to placebo in all three studies.1,2,3 Data from the pooled GALAXI 2 and 3 studies showed that guselkumab demonstrated greater efficacy compared to ustekinumab in endoscopic responseb and endoscopic remissionc both at Week 48, including the biologic naïve and prior biologic failure subgroups.1,2 Guselkumab European Commission approval in Crohn’s disease builds upon recent ulcerative colitis approval,4 marking the fourth indication for this dual-acting IL-23 inhibitor in the European Union.2