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A phase 3 trial found that subcutaneous risankizumab (Skyrizi) significantly outperformed placebo in achieving clinical remission and endoscopic response in Crohn's disease patients at week 12, with gains holding through week 24. The under-the-skin delivery method could ease access barriers tied to IV infusions. Researchers say the results are especially promising for treatment-naive patients as a potential first-line option.
A new phase 3 study called AFFIRM is making waves in the gastroenterology world. Subcutaneous (under-the-skin) risankizumab — already FDA-approved for Crohn's disease via IV infusion — showed significantly higher clinical remission and endoscopic response rates compared to placebo at week 12, with those gains continuing through week 24. The drug's safety profile was consistent with its established track record across other indications.
The big deal here isn't just efficacy — it's access. IV infusions can be a logistical challenge for patients in rural or remote areas. A subcutaneous option could make this IL-23 inhibitor far more accessible, particularly for patients who struggle to reach infusion centers.
Why it matters: For gastroenterologists managing moderate-to-severe Crohn's disease, a subcutaneous induction option could simplify treatment pathways and expand patient access — especially in underserved regions. The particularly high efficacy in biologic-naive patients also raises the possibility of risankizumab becoming a go-to first-line biologic choice.
