AbbVie received approval from the U.S. FDA for SKYRIZI (risankizumab-rzaa) as the first and only specific interleukin-23 (IL-23) inhibitor for the treatment of moderately to severely active Crohn’s disease (CD). In two induction and one maintenance clinical trials, SKYRIZI demonstrated significant improvements in endoscopic response (defined as a decrease of greater than 50% from the baseline Simple Endoscopic Score in CD for patients with isolated ileal disease and, at least a 2-point reduction from baseline) and clinical remission (defined as a Crohn’s Disease Activity Index [CDAI] of less than 150), compared to placebo, as both an induction and maintenance therapy.
 
The dosing regimen for SKYRIZI for the treatment of CD is 600 mg administered by intravenous infusion over at least one hour at week 0, week 4, and week 8, followed by 360 mg self-administered by subcutaneous injection (SC) with an on-body injector (OBI) at week 12, and every 8 weeks thereafter. A 180 mg self-administered SC maintenance dose option remains under review by the FDA.
 
This third approved indication for SKYRIZI is supported by safety and efficacy data from two induction and one maintenance clinical trials evaluating SKYRIZI in moderately to severely active Crohn’s disease, ADVANCE, MOTIVATE and FORTIFY.
 
As early as week 4 in the induction studies, clinical response and clinical remission were achieved by significantly more subjects treated with SKYRIZI versus placebo, as were co-primary endpoints of endoscopic response and clinical remission at week 12 and week 52.