Guselkumab Demonstrates Efficacy and Safety in Moderate-to-Severe Crohn’s Disease

Results from the Phase 3 GRAVITI study show that subcutaneous (SC) guselkumab is effective and well-tolerated for both induction and maintenance therapy in adults with moderately to severely active Crohn’s disease. The study met all primary and multiplicity-controlled secondary endpoints, including clinical and endoscopic outcomes through 48 weeks.

A total of 347 participants were randomized to receive guselkumab 400 mg SC every 4 weeks followed by either 100 mg every 8 weeks or 200 mg every 4 weeks, or placebo. Placebo patients meeting rescue criteria received active treatment after week 16.

At week 12, clinical remission rates were significantly higher in the guselkumab 400 mg group compared to placebo (56.1% vs 21.4%; P < .001). Guselkumab also produced greater endoscopic response at week 12 (41.3% vs 21.4%; P < .001). By week 48, sustained efficacy was observed, with clinical remission achieved in 60.0% (100 mg group) and 66.1% (200 mg group) compared to 17.1% in the placebo group (P < .001 for each). Endoscopic responses at week 48 were similarly robust: 44.3% and 51.3% in guselkumab groups vs 6.8% in placebo.

Notably, efficacy was seen in both biologic-naive participants and those with inadequate response or intolerance to prior biologics. Safety findings through week 48 were comparable to placebo and consistent with previous data in other approved indications, such as ulcerative colitis.

These findings support subcutaneous guselkumab as a promising treatment option for both induction and maintenance in Crohn’s disease, offering a durable and safe approach for patients across treatment histories.

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. 2025;169(2):308-325. doi:10.1053/j.gastro.2025.02.033