Guselkumab Demonstrates Efficacy and Safety in Phase 3 Study for Moderate to Severe Crohn’s Disease
Subcutaneous guselkumab showed significant clinical and endoscopic efficacy in patients with moderately to severely active Crohn’s disease, according to results from the Phase 3 GRAVITI study published in Gastroenterology. The randomized, double-blind, placebo-controlled trial evaluated both induction and maintenance regimens over 48 weeks.
A total of 347 adults were randomized 1:1:1 to receive either guselkumab 400 mg subcutaneously (SC) every 4 weeks followed by 100 mg SC every 8 weeks, guselkumab 400 mg SC every 4 weeks followed by 200 mg SC every 4 weeks, or placebo. Participants in the placebo group who met rescue criteria began guselkumab treatment at week 16.
The study met all multiplicity-controlled endpoints. At week 12, clinical remission was achieved by 56.1% of participants in the guselkumab group compared to 21.4% in the placebo group (Δ = 34.9; P < .001). Endoscopic response at week 12 was also significantly greater in the guselkumab arm (41.3%) versus placebo (21.4%; Δ = 19.9; P < .001).
Sustained efficacy was observed through week 48. Clinical remission rates at week 48 were 60.0% in the 100 mg every 8 weeks group and 66.1% in the 200 mg every 4 weeks group, compared with 17.1% in the placebo group (P < .001 for both comparisons). Endoscopic responses followed a similar pattern, with 44.3% and 51.3% achieving response in the guselkumab groups versus 6.8% in the placebo group (P < .001 each).
Notably, benefits were observed in both biologic-naive participants and those with prior inadequate response or intolerance to biologics. “Efficacy was observed in both bionaive participants and those with inadequate response/intolerance to biologics,” the study reported.
Safety outcomes were favorable, with adverse event rates comparable across all groups. “Safety findings were consistent with those of guselkumab in approved indications, including ulcerative colitis,” the authors stated.
These findings support subcutaneous guselkumab as an effective and well-tolerated treatment option for patients with moderate to severe Crohn’s disease.
Reference
Hart A, Panaccione R, Steinwurz F, et al. Efficacy and safety of guselkumab subcutaneous induction and maintenance in participants with moderately to severely active crohn's disease: results from the phase 3 graviti study. Gastroenterology. Published online March 18, 2025. doi:10.1053/j.gastro.2025.02.033
