Patients With Crohn’s Disease Show Response to Extended Treatment With Risankizumab

Most patients with Crohn’s disease who initially did not respond to IV induction with risankizumab, who then received 12 weeks of extended treatment, demonstrated improved clinical and endoscopic outcomes at Week 24, investigators reported recently in Clinical Gastroenterology and Hepatology.

Initial nonresponders to intravenous risankizumab induction at either 600mg or 1200mg at Weeks 0, 4, and 8 were rerandomized 1:1:1 to receive extended blinded treatment—either 1200mg IV at Weeks 12, 16, and 20, or subcutaneous (SC) risankizumab at 180mg or 360mg at Weeks 12 and 20. Patients who evidenced clinical response to subcutaneous risankizumab at Wee 24—classified as delayed responders—continued at the same dose in the FORTIFY trial.

The majority of initial nonresponders achieved stool frequency/abdominal pain score (SF/APS) clinical response by Week 24: 76.2% of those who received 180mg SC; 63.7% who were dosed at 360mg SC; and 62.3% of those treated with 1200mg IV. In addition, some also achieved Week 24 SF/APS clinical remission (43.0%, 45.1%, 22.1%, respectively), endoscopic response (32.4%, 32.5%, 40.5%, respectively), and endoscopic remission (25.1%, 18.0%, 23.5%, respectively).

Most delayed responders to SC risankizumab continued to demonstrate clinical response at FORTIFY Week 52 (56.7% at 180mg SC, 69.7% at 360mg SC), along with SF/APS clinical remission (43.3%, 54.5%), endoscopic response (36.7%, 45.5%), and endoscopic remission (40.0%, 42.4%).

“Numerically greater efficacy was generally observed with 360mg SC vs 180mg SC,” the investigators reported. “The safety profile of extended treatment was consistent with previously reported trials.

Reference:

Panaccione R, Ferrante M, Dotan I, et al.  Extended risankizumab treatment in patients with Crohn’s disease who did not achieve clinical response to induction treatment. Clin Gastroenterol Hepatol. Published online February 3, 2025