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We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: The FDA approved a subcutaneous induction regimen of risankizumab for adults with moderate to severe Crohn\u2019s 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\u2019s 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\u2019s 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. \u201cOne 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,\u201d 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. \u201cOne of the things we have learned with this class of medicines \u2014 the [interleukin]-23 p19 agents \u2014 is they seem to be incredibly safe for advanced therapies and highly effective.\u201d 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\u2019s 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. \u201cPeople living with Crohn\u2019s disease need treatments that can deliver meaningful disease control from the start,\u201d Roopal Thakkar, MD, AbbVie\u2019s chief scientific officer and executive vice president of research and development, said in the release. \u201cWith 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.\u201d Published by: Ask a clinical question and tap into Healio AI’s knowledge base.
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