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Tuesday, September 12, 2023

AbbVie SKYRIZI Met All Primary, Secondary Endpoints V. Stelara in Head-to-Head Study in Crohn's

 

  • 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

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