In active ulcerative colitis, risankizumab induced and maintained remission
An industry-funded study provided evidence that risankizumab can be considered a first-line or rescue therapy for moderate to severe ulcerative colitis, but with many medication options, cost may be a consideration, an ACP Journal Club commentary said.
Risankizumab improved clinical remission rates in patients with moderately to severely active ulcerative colitis (UC), a manufacturer-funded study found. The study included an induction trial with 975 patients and a maintenance trial with 548 patients. Remission rates were 20.3% with the drug versus 6.2% with placebo in the induction trial at week 12. At week 52 of the maintenance trial, rates were 37.6% to 40.2% (depending on the dose of risankizumab) versus 25.1% with placebo.
The study was published July 22 by JAMA. The following commentary by Alessandro Pedicelli, MD, PharmD, and Waqqas Afif, MD, MSc, was published in the ACP Journal Club section of Annals of Internal Medicine on Nov. 5.
The trials reported by Louis and colleagues provide evidence for the efficacy and safety of risankizumab compared with placebo for the induction and maintenance of remission in patients with UC. Risankizumab is the second interleukin (IL)–23 inhibitor, after mirikizumab, to be approved for the treatment of moderate-to-severe UC. Although the efficacies of the 2 medications appear similar, the risankizumab trials included patients with more severe UC (modified Mayo scores of 5 to 9 vs. 4 to 9 in the mirikizumab trial), more bio-experienced patients (75% in COMMAND vs. 41%), and more patients for whom >2 advanced therapies had failed (22% in COMMAND vs. 3%). In general, IL-23 medications are well-tolerated and the risankizumab induction and maintenance trials identified no new safety signals.
These data add to the growing list of approved advanced UC therapies, which now includes drugs that target IL-23 (risankizumab and mirikizumab), IL-12/IL-23 (ustekinumab), Janus kinase (tofacitinib and upadacitinib), sphingosine-1-phosphate (ozanimod and etrasimod), integrins (vedolizumab), and tumor necrosis factor-α (infliximab, adalimumab, and golimumab). Aside from one trial showing superiority of vedolizumab over adalimumab, no head-to-head trials help position one biologic over another for UC. Some data suggest the superiority of the IL-23 pathway over IL-12/IL-23 in Crohn disease, but whether these differences translate to UC is unclear.
Available advanced therapies for UC vary in their safety profiles and route and frequency of administration. Therefore, clinical factors and patient preferences play a central role in choosing one biologic over another.
Deciding on where risankizumab fits in the UC treatment paradigm is challenging. Given its proven efficacy in both biologically naive and experienced patients, risankizumab can certainly be considered a first-line or rescue therapy for those with moderate-to-severe UC. Given the availability of biosimilar molecules with similar efficacy in UC (infliximab and ustekinumab), cost considerations may play a role in the positioning of this new class of medications for moderate-to-severe UC.