October 23, 2026
2 min read
Key takeaways:
- The FDA approved a subcutaneous induction regimen of risankizumab for adults with moderate to severe Crohn’s disease.
- Patients can now start induction therapy at home.
The FDA has expanded its approval of Skyrizi to include subcutaneous induction for adults with moderately to severely active Crohn’s disease.
Risankizumab (Skyrizi, AbbVie) was approved in 2022 for this patient population as an IV induction regimen followed by subcutaneous maintenance.
The FDA has expanded its approval of Skyrizi to include subcutaneous induction for adults with moderately to severely active Crohn’s disease.
The latest approval allows patients to start treatment from home with an on-body injector induction pack, according to a manufacturer release.
Data from the phase 3 AFFIRM trial supported the approval, the release noted. Results showed nearly twice as many patients who received the subcutaneous induction regimen achieved clinical remission at week 12 when compared with placebo.
“One of the things that we as gastroenterologists want to do is use the safest, most effective therapy to hopefully treat [inflammatory bowel disease] early, achieve mucosal healing and prevent need for surgery or other complications in our patients,” Millie D. Long, MD, MPH, FACG, professor of medicine at University of North Carolina School of Medicine and lead investigator of the AFFIRM trial, previously told Healio. “One of the things we have learned with this class of medicines — the [interleukin]-23 p19 agents — is they seem to be incredibly safe for advanced therapies and highly effective.”
As Healio has reported, the AFFIRM trial investigated efficacy and safety of subcutaneous risankizumab induction in 289 adults with moderate to severe CD.
All study participants had a confirmed diagnosis for at least 3 months prior to enrollment and Crohn’s Disease Activity Index scores ranging from 220 to 450 at baseline.
Researchers randomly assigned patients 2:1 to receive a 720 mg subcutaneous risankizumab dose at baseline followed by either 720 mg doses at weeks 2, 5 and 8 (n = 191) or placebo (n = 98).
At week 12, risankizumab outperformed placebo in clinical remission (55% vs. 29.6%; delta = 26.6; 95% CI, 15.6-37.6) and endoscopic response (44% vs. 14.3%; delta = 29.4; 95% CI, 19.9-38.9).
Similar results were reported among patients who had not received prior advanced therapy (clinical remission, 73.1% vs. 27.3%; endoscopic response, 61.2% vs. 15.2%) and those who were intolerant or had inadequate response to other biologic therapies (clinical remission, 45.2% vs. 30.8%; endoscopic response, 34.7% vs. 13.8%).
According to the release, the most common adverse events related to risankizumab are upper respiratory infections, headache, joint and abdominal pain, injection-site reactions, anemia, fever, back pain, urinary tract infection and rash.
“People living with Crohn’s disease need treatments that can deliver meaningful disease control from the start,” Roopal Thakkar, MD, AbbVie’s chief scientific officer and executive vice president of research and development, said in the release. “With the approval of subcutaneous induction, we are building on the strong efficacy of Skyrizi while giving patients and physicians greater flexibility in how treatment is initiated.”
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