FDA Approves At-Home Start for Skyrizi in Crohn Disease
The FDA has approved a subcutaneous induction regimen for Skyrizi in adults with moderately to severely active Crohn disease, allowing treatment to start at home.
Adults with moderately to severely active Crohn disease can now start Skyrizi at home, under a new Skyrizi Crohn home induction regimen, after the Food and Drug Administration approved a subcutaneous induction regimen for the medicine on October 23. The new regimen uses risankizumab, sold as Skyrizi, delivered by an on-body injector induction pack at weeks 0, 2, 4, and 8, with maintenance dosing by the same device every eight weeks starting at week 12. Until now, patients began treatment with three intravenous infusions in a clinic, a routine that required travel, scheduling, and time in an infusion center.
Crohn disease is a chronic inflammatory condition of the digestive tract that can cause abdominal pain, diarrhea, fatigue, and weight loss, with flares that disrupt work, school, and daily life. Treatment aims to reduce inflammation, heal the gut lining, and keep symptoms in remission, but the way treatment starts can affect whether people begin and stay on therapy. An at-home start removes the infusion chair from the first weeks of care, while keeping the same medicine and the same maintenance schedule that patients already use.
Trial behind the Skyrizi Crohn home induction
The approval was based on the Phase 3 AFFIRM trial, a global, randomized, double-blind, placebo-controlled study in which 274 adults were randomized two to one to subcutaneous risankizumab or placebo. At week 12, 56 percent of treated patients reached clinical remission, compared with 30 percent on placebo, and 43 percent showed an endoscopic response, compared with 15 percent. No new safety signals were identified through week 24, and the safety profile was described as consistent with the known profile of risankizumab.
The intravenous induction option, 600 mg at weeks 0, 4, and 8, remains available for patients and clinicians who prefer it, so the new approval adds a choice rather than replacing an existing path. Patients will still need training on the on-body injector, monitoring for infection and other effects, and regular follow-up with a gastroenterology team. For many adults with Crohn disease, though, the ability to begin treatment at home, on a schedule that fits daily life, is a practical change that may make starting therapy easier.
Source: AJMC
