Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.
Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab . The incidence of adverse events was similar across treatment groups.
Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.
Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants , speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.
Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4