FDA Approves Subcutaneous Induction for AbbVie's SKYRIZI in Crohn's Disease, Letting Patients Start Treatment at Home
AbbVie (NYSE: ABBV) announced in North Chicago, Illinois, on October 23 that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) induction regimen for SKYRIZI (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease. Patients can now choose to start treatment at home, with induction doses delivered by an on-body injector (OBI), and then continue with the same device once every eight weeks for maintenance.
The SC induction regimen is 720 mg given by OBI at weeks 0, 2, 4 and 8; patients can also choose the existing intravenous option of 600 mg at weeks 0, 4 and 8. Maintenance dosing begins at week 12, once every eight weeks. SKYRIZI is an interleukin-23 (IL-23) inhibitor already approved for moderately to severely active ulcerative colitis, plaque psoriasis, psoriatic arthritis and Crohn's disease.
The approval rests on the Phase 3 AFFIRM study, which randomized 274 patients with moderately to severely active Crohn's disease 2-to-1. At week 12, clinical remission was 56% on SC SKYRIZI versus 30% on placebo, and endoscopic response was 43% versus 15%, meeting both co-primary endpoints. Results were strongest in patients without prior advanced therapy failure, with clinical remission of 74% versus 27% and endoscopic response of 60% versus 15%. AbbVie said the safety profile of SC induction was generally consistent with the known profile in Crohn's disease, with no new safety risks identified.
Roopal Thakkar, AbbVie's executive vice president for research and development and chief scientific officer, said people living with Crohn's disease need treatments that deliver meaningful disease control from the start, and that subcutaneous induction gives patients and physicians greater flexibility in how treatment is initiated. Millie D. Long of the University of North Carolina at Chapel Hill, the lead investigator of AFFIRM, said the approval answers the second question patients ask — how treatment fits into their lives — since patients can now start at home and continue the same way through maintenance.
The FDA also approved an update to the SKYRIZI U.S. prescribing information across all indications, revising the tuberculosis (TB) language so healthcare providers use clinical judgment when determining whether TB testing is needed; there is no mandatory TB test before starting SKYRIZI. Crohn's disease is a chronic inflammatory disease of the gastrointestinal tract, most commonly affecting the area between the small intestine and the colon, causing persistent diarrhea and abdominal pain and worsening over time.
Source: GSM · USA (original Chinese edition)
Photo: 艾伯维位于伊利诺伊州 North Chicago 的园区入口（资料图，右侧可见 AbbVie 标识）。照片：LittleT889 摄，CC BY 4.0，经维基共享资源／Entrance to AbbVie's North Chicago, Illinois campus (file photo). Photo: LittleT889, CC BY 4.0, via Wikimedia Commons
