User login
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
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
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