Efficacy and safety of risankizumab by baseline corticosteroid use and achievement of corticosteroid‐free clinical and endoscopic outcomes in patients with moderately to severely active Crohn's disease

Summary Background Risankizumab is efficacious and well tolerated in adults with moderately to severely active Crohn's disease (CD). Aim To evaluate the corticosteroid‐sparing effect of risankizumab in CD. Methods During the 12‐week induction period, patients maintained stable baseline corticosteroid doses, up to 20 mg/day prednisone or equivalent. At week 0 of maintenance, a mandatory corticosteroid taper was started. This post hoc analysis evaluated corticosteroid‐free clinical and endoscopic outcomes at week 52 of maintenance; safety was also assessed. Results Of 889 patients randomised to induction with risankizumab 600 mg or placebo, 285 (32.1%) were taking baseline concomitant corticosteroids. Week 12 clinical remission and endoscopic response rates were greater for risankizumab 600 mg versus placebo, regardless of concomitant corticosteroid use. At week 52, 66.7%, 50.0% and 41.2% of patients taking risankizumab 180 mg, risankizumab 360 mg and (withdrawal) placebo, respectively, discontinued corticosteroids. Week 52 corticosteroid‐free clinical remission per stool frequency/abdominal pain score (risankizumab 180 mg 42.7% or 360 mg 49.8%; withdrawal placebo 39.0%), corticosteroid‐free clinical remission per Crohn's Disease Activity Index (risankizumab 180 mg 51.0% or 360 mg 49.5%; withdrawal placebo 40.2%), and corticosteroid‐free endoscopic response (risankizumab 180 mg 44.6% or 360 mg 44.7%; withdrawal placebo 20.7%) rates were greater for risankizumab than placebo. Adverse event rates were generally similar, regardless of baseline corticosteroid use. Conclusions Efficacy of risankizumab 600 mg induction therapy was independent of concomitant corticosteroid use. Risankizumab 180 and 360 mg maintenance therapy yielded high rates of corticosteroid‐free clinical and endoscopic outcomes at week 52.