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;399:2031–36 doi: 10.1016/S0140-6736(22)00466-4
Maintenance treatment with risankizumab was associated with an improvement in coprimary endpoints of clinical remission and endoscopic response in patients with Crohn’s disease compared with placebo.
Ferrante et al described results from the FORTIFY substudy 1 on the efficacy of continuing risankizumab as maintenance therapy, using patients from the ADVANCE and MOTIVATE studies. Higher rates of efficacy were shown in both treatment groups compared with the withdrawal (placebo) group, and a greater treatment effect was generally observed in the higher 360mg dose versus 180mg. Both Risankizumab doses were well tolerated over the maintenance period, with no new safety risks identified.