FDA Approves At-Home Subcutaneous Skyrizi Induction for Crohn’s Disease
With the FDA approval announced October 23, 2026, adults with moderately to severely active Crohn’s disease can now start Skyrizi with injections at home rather than sitting through infusion visits, using 720 mg subcutaneous doses delivered by an on-body injector at weeks 0, 2, 4 and 8, followed by maintenance every eight weeks. The move makes Skyrizi a fully self-administered biologic from day one if patients and their doctors choose the at-home path. Here is what changed, what the trial showed, and what to discuss at your next appointment.
Key Takeaways:
- – The FDA approved subcutaneous (SC) induction for Skyrizi in adults with moderately to severely active Crohn’s disease on October 23, 2026.
- – SC induction dosing is 720 mg via on-body injector at weeks 0, 2, 4 and 8, then maintenance via an OBI every eight weeks from week 12.
- – In the Phase 3 AFFIRM trial, SC Skyrizi beat placebo on both co-primary endpoints: clinical remission and endoscopic response at week 12.
- – Advanced therapy-naive patients did best: 74% reached clinical remission by week 12 versus 27% on placebo, and endoscopic response ran 60% versus 15%.
- – An on-body injector at-home delivery option was already the maintenance standard, so treatment patterns now start from day one.
What exactly changed today
Before Friday, newly diagnosed or newly advanced-therapy patients starting Skyrizi faced one certain option: 600 mg intravenous infusions delivered at weeks 0, 4 and 8 in an infusion suite, followed by at-home self-injections for maintenance. Induction was also available subcutaneously only after approval in 2022 for maintenance, so a patient had to first sit through an IV cycle before starting the injections they would live with for years.
The approval removes that split. Patients and their gastroenterologists can choose SC induction from day one, with the same OBI device used throughout, according to AbbVie’s own announcement. That is one less access pattern to coordinate: a patient starting medication during a flare no longer needs weekly clinic visits before starting effective biologic therapy. For rural patients an hour or more from an infusion center, that difference can decide when treatment actually starts.
What the AFFIRM trial showed
The submission rested on the Phase 3 AFFIRM study, which tested SC Skyrizi against placebo in adults with moderately to severely active Crohn’s disease. Across the overall population, Skyrizi hit both co-primary endpoints, logging 56% clinical remission at week 12 against 30% placebo, and 43% endoscopic response against 15% placebo.
The results were strongest in patients new to advanced therapy, the group that includes most newly treated Crohn’s patients. In that subgroup, 74% reached clinical remission versus 27% on placebo, a steep gap, and endoscopic response ran roughly four times placebo rates, 60% versus 15% per AbbVie’s reporting. The safety profile was called generally consistent with Skyrizi’s known profile in Crohn’s disease, with no new safety risks found in the trial.
Secondary endpoints also showed benefit, including endoscopic remission and fatigue improvements scored on FACIT instruments at week 12, which matters because fatigue is one of the most disabling day-to-day symptoms patients report.
Who qualifies and how treatment is delivered
The approval covers adults with moderately to severely active Crohn’s disease, and the induction pack delivers 720 mg per dose, three weeks apart in a OBI induction kit schedule. Patients who prefer it can still choose the existing IV option of 600 mg at weeks 0, 4 and 8. From week 12 onward, maintenance runs every eight weeks via OBI for either pathway. Patients should treat the OBI as a single-use cap that stays on the body during each controlled dose.
Real-world experience with the OBI device is largely reassuring: among 186 people with Crohn’s using it, 88% reported the device was easy to use, and a separate patient survey found 87% satisfied or highly satisfied with the OBI versus 71% with a standard autoinjector. The practical point for patients is that the OBI algorithm automates an entire infusion-capable workflow without vials or any preparation steps.
What this means for cost and coverage
Biologic drugs in the Crohn’s class often list from several thousand dollars up to five figures per year before insurance and copay programs, and Skyrizi is among the priciest. AbbVie’s announcement does not name a US list price for the SC induction kit, so the net cost question ultimately depends on your insurer’s tier, prior authorization rules and whether you qualify for AbbVie’s copay savings program. Employers plans, Medicare Part D plans and state Medicaid plans all manage Skyrizi differently, so the practical advice is to ask your gastroenterologist’s office to initiate a benefits check before your first fill rather than treating it as routine.
For clinics, the approval shifts scheduling rather than ends it. Gastroenterology groups that built infusion suites around induction IVs will describe the option to patients and route them back for maintenance bloodwork or disease monitoring visits. Expect prior authorization templates for Crohn’s Skyrizi to be updated over the coming weeks to cover the new induction pathway.
What happens next
Three watchpoints stand out. First, look for an updated Prescribing Information and label PDF reflecting the SC induction language; the FDA label update is the authoritative version for prescribers. Second, watch insurance formularies: if AbbVie prices the SC induction pack aggressively, some plans will prefer it over IV site fees, another market dynamic that could reshape where infusions actually happen. Third, AbbVie presented fresh AFFIRM endoscopic outcome data at a major gastroenterology meeting on October 13, and those results plus the approval set up broader trial programs to test subcutaneous induction across inflammatory bowel disease indications beyond Crohn’s.
For patients, the practical takeaway today is straightforward: if you are starting Skyrizi and squeezing it around work or school is the barrier, ask whether the new at-home SC induction route is an option for you. It is a real shift in how Crohn’s treatment can begin, with the strongest results showing up in the patients who start earliest.
Frequently Asked Questions
Can I start Skyrizi at home for Crohn’s disease?
Yes. As of the October 23, 2026 FDA approval, adults with moderately to severely active Crohn’s disease can begin with a subcutaneous induction regimen at home, delivered by an on-body injector at weeks 0, 2, 4 and 8, if their doctor prescribes that route.
How is subcutaneous Skyrizi induction dosed?
The approved SC induction schedule is 720 mg at weeks 0, 2, 4 and 8, with maintenance injections every eight weeks starting at week 12, all self-administered with the OBI device.
What did the AFFIRM trial show for subcutaneous Skyrizi?
Subcutaneous Skyrizi beat placebo on both co-primary endpoints at week 12: 56% versus 30% clinical remission overall, and 74% versus 27% remission among patients who had not failed advanced therapy before, with no new safety risks identified.
Sources:
- https://news.abbvie.com/2026-10-23-U-S-FDA-Approves-Subcutaneous-Induction-Regimen-for-AbbVies-SKYRIZI-R-risankizumab-rzaa-for-Adults-With-Moderately-to-Severely-Active-Crohns-Disease
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761105s045lbl.pdf
- https://news.abbvie.com/2026-04-27-AbbVie-Submits-Regulatory-Application-to-FDA-for-SKYRIZI-R-risankizumab-rzaa-Subcutaneous-Induction-for-Adults-with-Moderately-to-Severely-Active-Crohns-Disease
