Phase 3 Maintenance Results Show Patients with Crohn s Disease Receiving Risankizumab (SKYRIZI®) Achieved Endoscopic Response and Clinical Remission at One Year
- In Crohn s disease patients with clinical response to risankizumab IV induction treatment, a significantly greater proportion of patients treated with risankizumab 360 mg SC achieved endoscopic response and clinical remission at one year (52 weeks) versus those who were withdrawn from risankizumab (control group)[1]
- The overall safety results in this study were generally consistent with the known safety profile of risankizumab, with no new safety risks observed[1-7]
- Risankizumab (SKYRIZI), an interleukin-23 (IL-23) inhibitor, is being evaluated as a treatment for adults with moderate to severe Crohn s disease and several other immune-mediated conditions[1,8-10]
ABBVie today announced positive top-line results from the Phase 3 maintenance study, FORTIFY, showing risankizumab 360 mg achieved the co-primary endpoints of endoscopic response and clinical remission at one year in adult patients with moderate to severe Crohn's disease. 1 In this study, patients who responded to 12 weeks of risankizumab intravenous induction treatment were re-randomized to receive risankizumab 180 .
ABBVie today announced that it has submitted applications seeking approval for SKYRIZI ® to the U.S. Food and Drug Administration and for SKYRIZI ® to the European Medicines Agency for the treatment of adults with active psoriatic arthritis. 1 The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including …
ABBVie (NYSE: ABBV) today announced that it has submitted applications seeking approval for SKYRIZI ® (risankizumab-rzaa, 150 mg) to the U.S. Food and Drug Administration (FDA) and for SKYRIZI ® (risankizumab, 150 mg) to the European Medicines Agency (EMA) for the treatment of adults with active psoriatic arthritis. 1 The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy andor non-b