Adults with moderately to severely active Crohn disease can now start risankizumab with an on-body injector at home and keep using the same device for maintenance. They no longer need intravenous infusions to begin.
The FDA on Friday approved a subcutaneous (SC) induction regimen for risankizumab-rzaa (Skyrizi; AbbVie) in adults with moderately to severely active
Under the new regimen, patients receive 720 mg of risankizumab via an OBI induction pack at weeks 0, 2, 4, and 8, then continue maintenance dosing with the OBI every 8 weeks starting at week 12.2 The intravenous (IV) induction option, 600 mg at weeks 0, 4, and 8, remains available.2 With the SC route, the interleukin-23 inhibitor becomes a fully self-administered therapy from the first dose, according to manufacturer AbbVie.1
“When patients and I discuss treatment, they want to know 2 things: will it work? And how will it fit into their lives?” Millie D. Long, MD, MPH, chief of the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill and lead investigator of the AFFIRM trial, said in a statement.
“AFFIRM answered the first question, with superior rates of clinical remission and endoscopic response versus placebo during induction with subcutaneous [risankizumab] particularly in patients new to advanced therapy. This approval answers the second. As a physician who has used the Skyrizi OBI, I’ve seen firsthand the convenience it can offer patients. Now with this approval, patients can start treatment at home and continue the same way through maintenance.”1
The OBI was introduced in 2022 for maintenance treatment in Crohn disease, so many patients and clinicians already know the device.1 In the real-world ASPIRE-CD survey of 186 adults with Crohn disease, 88% said the OBI was easy to use.3 In a separate patient-reported survey of 352 adults with inflammatory bowel disease, 87% said they were satisfied or highly satisfied with the OBI, compared with 71% for an autoinjector.4
Removing IV infusions from the start of treatment addresses a practical barrier in a chronic, progressive disease whose unpredictable symptoms already carry physical, emotional, and economic burdens.5IV induction typically requires scheduled visits to an infusion site, along with travel and time away from work or family.
The approval is based on the phase 3 AFFIRM trial (
At week 12, SC risankizumab met both coprimary end points: Clinical remission, defined as a Crohn’s Disease Activity Index score below 150, was achieved by 56% of patients vs 30% with placebo, and endoscopic response by 43% vs 15% (P < .001 for both).2 Results were strongest in patients without prior advanced therapy failure: 74% reached clinical remission vs 27% with placebo, and 60% achieved endoscopic response vs 15%.2 Among patients who had failed advanced therapy, clinical remission rates were 45% vs 31%.2
Longer-term data presented this month at the American College of Gastroenterology 2026 Annual Scientific Meeting showed that 35.8% of patients receiving SC risankizumab achieved endoscopic remission at week 24 vs 9.1% with placebo, and 36.6% of those with ulcers at baseline achieved ulcer-free endoscopy vs 9.1%.7 Among advanced therapy–naive patients, those rates rose to 45.1% and 49.0%, respectively.7
The safety profile of SC induction was consistent with the known profile of risankizumab in Crohn disease, with no new safety signals identified through week 24.2,7
Alongside the new regimen, the FDA approved a change to the warnings and precautions section of the risankizumab label across all indications, allowing clinicians to use their judgment in deciding whether to test for tuberculosis before starting treatment. Testing is no longer mandatory.1,2
Risankizumab is also approved for ulcerative colitis, plaque psoriasis, and psoriatic arthritis.2
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