FDA Approves Subcutaneous Induction for AbbVie's Skyrizi in Crohn's Disease
The U.S. Food and Drug Administration has approved a subcutaneous induction regimen for AbbVie's Skyrizi (risankizumab-rzaa) in adults with moderately to severely active Crohn's disease. According to AbbVie, patients can now start treatment at home using an on-body injector and stay on the same device through maintenance.
- The FDA approved a subcutaneous induction regimen for Skyrizi in adults with moderately to severely active Crohn's disease.
- Induction is 720 mg by on-body injector at weeks 0, 2, 4 and 8, with maintenance by OBI every eight weeks from week 12.
- In AFFIRM, 56% of patients on subcutaneous Skyrizi reached clinical remission at week 12 versus 30% on placebo.
- Among advanced therapy-naïve patients, clinical remission was 74% versus 27% on placebo.
- The FDA also updated TB language so providers can use clinical judgment on testing before treatment.
Home-based start with an on-body injector
AbbVie said the approval gives patients the option to begin Skyrizi at home, with induction doses delivered by an on-body injector (OBI) induction pack. Patients then continue with an OBI once every eight weeks during maintenance treatment.
The subcutaneous induction dose is 720 mg, given at weeks 0, 2, 4 and 8. Maintenance dosing by OBI starts at week 12. Patients can still choose to begin treatment intravenously, with 600 mg delivered at weeks 0, 4 and 8.
The Skyrizi OBI was first introduced in 2022 for Crohn's disease maintenance treatment. AbbVie cited a real-world survey of 186 people with Crohn's disease in which 88% found the device easy to use. In a separate patient-reported survey of 352 adults with inflammatory bowel disease, 87% were satisfied or highly satisfied with the OBI, compared with 71% for an autoinjector.
Results from the Phase 3 AFFIRM study
The approval rests on the Phase 3 AFFIRM trial, a global, randomized, placebo-controlled, double-blind study. A total of 274 patients were randomized 2:1 to subcutaneous risankizumab or placebo, and 65% had previously failed advanced therapies. The co-primary endpoints were clinical remission, defined as a Crohn's disease activity index below 150, and endoscopic response at week 12. According to AbbVie, Skyrizi achieved superiority on both.
In the total population, clinical remission at week 12 was reached by 56% of patients on Skyrizi versus 30% on placebo. Endoscopic response was 43% versus 15%, and endoscopic remission was 26% versus 11%. AbbVie reported p<0.001 against placebo in the total population.
Results were strongest in patients without prior advanced therapy failure. In this group, 74% reached clinical remission versus 27% on placebo, and 60% achieved endoscopic response versus 15%. Endoscopic remission was 43% versus 9%. Among patients who had previously failed advanced therapy, clinical remission was 45% versus 31% and endoscopic response 33% versus 15%.
Skyrizi also met secondary endpoints, including endoscopic remission and FACIT fatigue scores at week 12. AbbVie said the safety profile was generally consistent with the known profile in Crohn's disease, with no new safety risks observed.
Change to tuberculosis language in the label
The FDA also approved an update to the warnings and precautions in the U.S. Prescribing Information across all Skyrizi indications. The revised label advises healthcare providers to consider TB evaluation before starting treatment, based on clinical judgment. AbbVie stated that there is no mandatory TB test prior to initiating Skyrizi.
What it means for patients and physicians
For people with Crohn's disease, the approval removes the need to begin treatment with an intravenous infusion, though that option remains available. Roopal Thakkar, AbbVie's chief scientific officer, said the approval gives "patients and physicians greater flexibility in how treatment is initiated."
Millie D. Long of the University of North Carolina at Chapel Hill, lead investigator of AFFIRM, said patients "can start treatment at home and continue the same way through maintenance." The AFFIRM study continues with an extended period through week 24 and a 52-week open-label extension, as described by AbbVie.
