Conference Coverage

Long-term Subcutaneous Risankizumab is Well-Tolerated in Patients With Moderate-to-Severe Crohn Disease, Delayed Response to IV Risankizumab

According to the results of a study presented at The American College of Gastroenterology 2022 Annual Scientific Meeting in Charlotte, NC, subcutaneous maintenance dosing of risankizumab, an anti-p19 interleukin-23 inhibitor, is effective and well-tolerated at 52 weeks in patients with moderate-to-severe Crohn disease (CD) who had a delayed response to 12-week intravenous (IV) risankizumab induction during the ADVANCE and MOTIVATE studies.

The ADVANCE and MOTIVATE phase 3 studies evaluated the efficacy and safety of risankizumab vs placebo during 12-weeks of induction therapy for patients with moderately to severely active CD. The study results showed that IV risankizumab was superior to the placebo for achieving clinical and endoscopic endpoints at 12 weeks.

In the current FORTIFY maintenance study, researchers examined patients who did not achieve clinical response (defined as ≥ 30% decrease in average daily stool frequency [SF] and/or ≥ 30% decrease in average daily abdominal pain score [APS]) following 12-weeks of IV risankizumab induction dosing (600 mg or 1200 mg), but who did achieve clinical response following an additional 12 weeks of subcutaneous maintenance dosing of risankizumab. These patients (n = 63) were considered “delayed responders.”

The researchers found that at week 52, most delayed responders achieved clinical remission and response with 180 mg (n = 30) or 360 mg (n = 33) of risankizumab. In addition, patients who received subcutaneous maintenance dosing of risankizumab (180 mg or 360 mg) also achieved endoscopic response (36.7%, 45.5%, respectively), endoscopic remission (40.0%, 42.4%), deep remission (40.0%, 39.4%), ulcer-free endoscopy (27.6%, 24.2%), and the combined endpoint of SF/APS clinical remission plus endoscopic response (23.3%, 36.4%). Subcutaneous maintenance dosing of risankizumab was also well-tolerated by the delayed responders.

“These findings underscore the additional clinical benefit of subcutaneous risankizumab treatment, even in patients who were initial non-responders to 12 weeks of IV risankizumab induction,” the researchers concluded.


—Anthony Calabro


D’Haens G, Panaccione R, Panés J, et al. 52-week risankizumab subcutaneous maintenance dosing is efficacious and well tolerated in patients with moderate to severe Crohn’s disease who had delayed response to 12-weeks IV risankizumab induction. Talk presented at: ACG 2022; October 21-26, 2022; Charlotte, NC. Accessed October 19, 2022.