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AbbVie's SKYRIZI® (risankizumab) Met All Primary and Secondary Endpoints Versus Stelara® (ustekinumab) in Head-to-Head Study in Crohn's Disease

Published: 2023-09-12 12:30:00 ET

SEQUENCE, a Phase 3 head-to-head study (study drug open-label and efficacy assessment blinded) compared risankizumab to ustekinumab for the treatment of adult patients with moderately to severely active Crohn's disease who have failed one or more anti-TNFs1
Risankizumab met both primary endpoints of non-inferiority for clinical remission (Crohn's Disease Activity Index [CDAI]) at week 24 and superiority of endoscopic remission at week 48 versus ustekinumab
All secondary endpoints achieved statistical significance for superiority versus ustekinumab
Safety results were consistent with the overall safety profile of risankizumab, with no new safety risks identified

NORTH CHICAGO, Ill., Sept. 12, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced 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

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