AbbVie Reports Top-line Results From Phase 3 SEQUENCE Clinical Trial Of Risankizumab
(RTTNews) - Biopharmaceutical company AbbVie, Inc. (ABBV) announced Tuesday top-line results from the Phase 3 SEQUENCE clinical trial evaluating risankizumab (SKYRIZI, 600 mg intravenous [IV] induction at week 0, 4 and 8 and 360 mg subcutaneous injection [SC] starting at week 12 and every 8 weeks thereafter) versus ustekinumab (STELARA, IV dose at week 0 and 90 mg SC every 8 weeks thereafter) through week 48 in patients with moderately to severely active Crohn's disease who have failed one or more anti-TNFs.
The results of the first primary endpoint, clinical remission (per Crohn's Disease Activity Index [CDAI], defined as CDAI <150) at week 24, met non-inferiority of risankizumab versus ustekinumab, with remission rates of 59% in risankizumab group and 40% in ustekinumab group.
The results of the second primary endpoint, endoscopic remission at week 48 met superiority of risankizumab versus ustekinumab, with remission rates of 32% in risankizumab group and 16% in ustekinumab group.
The safety profile of risankizumab in the SEQUENCE study was consistent with the known safety profile of risankizumab.
Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
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