HealthDay News — Skyrizi (risankizumab-rzaa), an interleukin-23 inhibitor, has received US Food and Drug Administration approval to treat moderately to severely active Crohn disease (CD) in adults, according to AbbVie.
Approved dosing for Skyrizi for the treatment of CD is 600 mg by intravenous infusion over at least 1 hour at week 0, week 4, and week 8, followed by 360 mg self-administered by subcutaneous injection with an on-body injector at week 12 and every 8 weeks thereafter.
The company reported that in 2 induction trials and 1 maintenance clinical trial, Skyrizi demonstrated significant improvements in endoscopic response (defined as a decrease of >50% from the baseline Simple Endoscopic Score in Crohn disease [SES-CD] or for patients with isolated ileal disease and SES-CD of 4, at least a 2-point reduction from baseline) compared with placebo. Additionally, Skyrizi was associated with clinical remission (defined as a Crohn Disease Activity Index of less than 150) vs placebo, as both an induction and maintenance therapy. Clinical response and clinical remission were seen as early as week 4 in induction studies.
“In both the induction and maintenance clinical trials, a significantly greater number of adult patients saw few or no symptoms and a meaningful reduction of visible signs of intestinal inflammation, compared to placebo,” Marla Dubinsky, MD, a paid consultant and advisor for AbbVie, said in a statement. “This approval provides health care professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn’s disease.”