- In Crohn’s disease patients with clinical response to risankizumab IV induction treatment, a significantly greater proportion of patients treated with risankizumab 360 mg SC achieved endoscopic response and clinical remission at one year (52 weeks) versus those who were withdrawn from risankizumab (control group)
- The overall safety results in this study were generally consistent with the known safety profile of risankizumab, with no new safety risks observed
- Risankizumab (SKYRIZI), an interleukin-23 (IL-23) inhibitor, is being evaluated as a treatment for adults with moderate to severe Crohn’s disease and several other immune-mediated conditions
AbbVie announced positive top-line results from the Phase 3 maintenance study, FORTIFY, showing risankizumab 360 mg (subcutaneous [SC]; administered every eight weeks) achieved the co-primary endpoints of endoscopic response and clinical remission at one year in adult patients with moderate to severe Crohn’s disease.
In this study, patients who responded to 12 weeks of risankizumab intravenous (IV) induction treatment (in a prior study) were re-randomized to receive risankizumab 180 mg, risankizumab 360 mg or withdrawal from risankizumab treatment (risankizumab IV induction-only control group). This study included different sets of primary and secondary endpoints for the U.S. analysis plan and the outside of the U.S. (OUS) analysis plan due to regulatory requirements in the different regions.1 The co-primary endpoints were endoscopic response and clinical remission at week 52.1 Clinical remission was defined by Crohn’s Disease Activity Index (CDAI) in the U.S. analysis plan and by stool frequency and abdominal pain (SF/AP) in the OUS analysis plan.
After one year, 47 percent of patients receiving risankizumab 360 mg achieved endoscopic response compared with 22 percent of patients in the induction-only control group (p<0.001).1 Significantly more patients receiving risankizumab 360 mg achieved clinical remission (CDAI; U.S. analysis plan), with 52 percent on risankizumab 360 mg achieving clinical remission versus 41 percent in the induction-only control group (p<0.01).1 Results also showed that 52 percent of patients receiving risankizumab 360 mg achieved clinical remission (SF/AP; per OUS analysis plan) compared to 40 percent in the induction-only control group (p=0.004).1 In addition, 39 percent of patients receiving risankizumab 360 mg achieved endoscopic remission compared to 13 percent of patients in the induction-only control group (nominal p<0.001).1 Furthermore, 29 percent of risankizumab 360 mg-treated patients achieved deep remission compared to 10 percent in the induction-only control group (nominal p<0.001).1 Deep remission is a stringent endpoint defined by clinical remission (CDAI) and endoscopic remission, both measured in the same patient.
“In our global clinical trial program to-date, risankizumab has shown clinically meaningful rates of endoscopic response and clinical remission among patients living with moderate to severe Crohn’s disease,” said Michael Severino, M.D., vice chairman and president, AbbVie. “These results represent another step towards the development of risankizumab for these patients, many of whom do not find sufficient disease control with current treatments.”