AbbVie Reports P-III Study (INSPIRE) Results of Skyrizi (risankizumab) in P-III Induction Study (INSPIRE) for Ulcerative Colitis
- The P-III study (INSPIRE) evaluating risankizumab (1200mg, IV, q4w) as induction therapy vs PBO in 1554 patients with moderately to severely active UC
- The trial met its 1EPs & 2EPs i.e., patients treated with risankizumab (IL-23 inhibitor) achieved clinical remission (20.3% vs 6.2%); clinical response (64.3% vs 35.7%); endoscopic improvement (36.5% vs 12.1%) & histologic-endoscopic mucosal improvement (24.5% vs 7.7%). The safety profile was consistent with the prior studies across other indications with no new safety risks
- Serious AEs (2.3% vs 10.2%); rates of serious inf. (0.6% vs 1.2%), no adjudicated MACE with no adjudicated anaphylactic reaction events & no malignancy events were reported in the risankizumab group
Ref: AbbVie | Image: AbbVie
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