Subcutaneous risankizumab (Skyrizi) as induction therapy significantly improved outcomes in patients with moderately to severely active Crohn's disease, according to phase III data from the AFFIRM trial presented at the American College of Gastroenterology annual meeting. At 12 weeks, 55% of treated patients reached clinical remission by CDAI, compared with 29.6% on placebo; endoscopic response was 44% versus 14.3%.
The trial enrolled 289 adults with refractory disease: roughly a third were anti-TNF naive, while others had failed ustekinumab or JAK inhibitors. Endoscopic remission and ulcer-free endoscopy rates were also higher with risankizumab. Among induction responders who continued subcutaneous maintenance through week 24, 67.2% maintained clinical remission versus 29.6% of placebo responders.
Risankizumab is currently approved as intravenous induction followed by subcutaneous maintenance, but AbbVie has submitted an application to the FDA for subcutaneous induction. Presenter Millie D. Long of UNC said she plans to "move predominantly to subcutaneous" once available, citing the flexibility it would offer patients.