Phase 3 maintenance data from FORTIFY study show patient with moderate to severe Crohn's disease receiving risankizumab achieved endoscopic response and clinical remission at one year
RCT (n=462) of this IL-23 inhibitor administered at dose of 360 mg subcut every 8 weeks achieved co-primary endpoints compared with induction-only control group of endoscopic response (47 vs. 22%; p<0.001) and clinical remission (52 vs 41%; p<0.01) at one year
Source:
Biospace Inc.
SPS commentary:
These results are from the 52-week pivotal portion of the FORTIFY Phase 3 study, which was designed to evaluate the efficacy and safety of risankizumab as maintenance therapy versus risankizumab IV induction-only in patients with moderate to severe Crohn's disease who responded to risankizumab induction treatment in the ADVANCE or MOTIVATE induction studies.