In the Phase 3 INSPIRE induction study, a higher percentage of patients with moderate to severe active ulcerative colitis who received risankizumab achieved clinical remission (measured by the Adapted Mayo Score) compared to those who received placebo at week 12. Moreover, all key secondary endpoints were met. The safety results of the study were consistent with the known safety profile of Skyrizi.
The INSPIRE study included patients who were either intolerant or had an inadequate response to conventional therapies such as JAK inhibitors, biologics, and S1P receptor modulators.
Compared to the placebo, a significantly higher percentage of patients treated with risankizumab achieved endoscopic improvement at week 12 (36.5% versus 12.1%). Additionally, a higher percentage of patients treated with risankizumab (24.5%) achieved histologic-endoscopic mucosal improvement at week 12 compared to those receiving a placebo (7.7%).
The safety profile of Skyrizi was consistent with the existing profile, and no new adverse events were reported.
AbbVie is conducting a trial to determine the efficacy of Skyrizi as a maintenance therapy.