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  • Phase III FORTIFY study of Skyrizi meets endpoints...
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Phase III FORTIFY study of Skyrizi meets endpoints in Crohn's disease.- AbbVie

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Published:3rd Jun 2021
AbbVie announced positive top-line results from the Phase III maintenance study, FORTIFY, showing Skyrizi (risankizumab) 360 mg subcutaneous [SC]; administered every eight weeks, achieved the co-primary endpoints of endoscopic response and clinical remission at one year in adult patients with moderate to severe Crohn's disease.

 In this study, patients who responded to 12 weeks of risankizumab intravenous (IV) induction treatment (in a prior study) were re-randomized to receive risankizumab 180 mg, risankizumab 360 mg or withdrawal from risankizumab treatment (risankizumab IV induction-only control group). This study included different sets of primary and secondary endpoints for the U.S. analysis plan and the outside of the U.S. (OUS) analysis plan due to regulatory requirements in the different regions. The co-primary endpoints were endoscopic response and clinical remission at week 52. Clinical remission was defined by Crohn's Disease Activity Index (CDAI) in the U.S. analysis plan and by stool frequency and abdominal pain (SF/AP) in the OUS analysis plan. After one year, 47 percent of patients receiving risankizumab 360 mg achieved endoscopic response compared with 22 percent of patients in the induction-only control group (p<0.001). significantly more patients receiving risankizumab 360 mg achieved clinical remission (cdai; u.s. analysis plan), with 52 percent on risankizumab 360 mg achieving clinical remission versus 41 percent in the induction-only control group (p><0.01). results also showed that 52 percent of patients receiving risankizumab 360 mg achieved clinical remission (sf ap; per ous analysis plan) compared to 40 percent in the induction-only control group (p="0.004)." in addition, 39 percent of patients receiving risankizumab 360 mg achieved endoscopic remission compared to 13 percent of patients in the induction-only control group (nominal p><0.001). furthermore, 29 percent of risankizumab 360 mg-treated patients achieved deep remission compared to 10 percent in the induction-only control group (nominal p><0.001).></0.001).></0.001).></0.01).></0.001).>

Condition: Crohns
Type: drug

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