FDA Approves At-Home Start for AbbVie's SKYRIZI in Crohn's Disease

FDA approved a subcutaneous induction option for AbbVie's SKYRIZI (risankizumab-rzaa) in adults with moderately to severely active Crohn's disease on 23 October 2026. Since its original 2022 approval, starting SKYRIZI for Crohn's has required three intravenous infusions, each lasting at least an hour, before patients could move to an at-home maintenance injection. The new regimen removes the infusion requirement entirely: patients can now induce and maintain treatment with the same on-body injector, start to finish.

What changes, and what does not

SKYRIZI's original 2022 approval made it the first interleukin-23 (IL-23) specific inhibitor cleared for Crohn's disease, but it carried an induction regimen built around the infusion chair: 600 mg delivered intravenously over at least an hour at weeks 0, 4 and 8, before patients transitioned to a 360 mg subcutaneous injection, self-administered with an on-body injector, at week 12 and every eight weeks after. The approval announced on 23 October 2026 adds a second induction path that skips the infusion center altogether — 720 mg delivered subcutaneously by on-body injector at weeks 0, 2, 4 and 8 — with patients and physicians free to choose either route. Maintenance dosing is unchanged, and the IV option remains on the label for patients or sites that prefer it.

The trial behind the new regimen

The subcutaneous induction regimen rests on the Phase 3 AFFIRM study, which randomized 289 adults with moderately to severely active Crohn's disease 2:1 to subcutaneous risankizumab or placebo. The population skewed toward patients who had already run out of options: 65% had failed at least one advanced therapy before enrolling, roughly half had failed two or more, 23% had failed ustekinumab and 12% had failed a Janus kinase inhibitor. At week 12, the co-primary endpoints both favored the subcutaneous arm by a wide margin — CDAI clinical remission in 55% of patients versus 30% on placebo, and endoscopic response in 44% versus 14% (both p<0.0001). AbbVie reported those topline results in March 2026, and FDA's October approval is the first regulatory action to rely on them.

Safety and labeling

AbbVie said the subcutaneous induction regimen produced no new safety signals relative to SKYRIZI's existing profile. As part of this approval, FDA updated the tuberculosis-related warnings and precautions language in the drug's prescribing information across all of its approved indications — Crohn's disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis and others — rather than limiting the change to the new regimen alone. The exact revised language belongs in the updated label once FDA posts it, not in secondary summaries.

What this changes operationally

• Site of care: gastroenterology practices that have built Crohn's onboarding around three infusion-chair visits can now offer an entirely at-home start, which changes scheduling, nursing time, and the first-dose observation period sites may still want to build in for safety monitoring.
• Prior authorization and formulary language: payer policies written around “IV induction followed by SC maintenance” will need updating to reflect two valid induction pathways; regulatory and managed-markets teams should expect a lag before benefit verification systems catch up.
• Labeling consistency: because the tuberculosis warning update applies across all SKYRIZI indications, not just Crohn's, medical affairs teams supporting other indications should confirm their patient materials and REMS-adjacent communications reflect the revised language too.
• Competitive context: an at-home induction option narrows one of the practical differences between SKYRIZI and IL-23 and anti-TNF competitors that already offer subcutaneous-only regimens in Crohn's disease.

What is not yet settled

FDA's approval letter and the updated SKYRIZI prescribing information, once published, will govern the precise tuberculosis-labeling language, any monitoring recommendations tied to the new induction regimen, and the full safety database supporting it. AbbVie's own disclosures to date cover topline AFFIRM efficacy and a general no-new-safety-signal statement; the complete adverse-event tables and any post-marketing commitments belong in that primary documentation, not in trade-press summaries.

Frequently asked questions

What did FDA approve, and when?

On 23 October 2026, FDA approved a subcutaneous induction regimen for SKYRIZI (risankizumab-rzaa) in adults with moderately to severely active Crohn's disease, letting patients start treatment entirely by subcutaneous injection rather than intravenous infusion.

How does the new regimen work?

720 mg by on-body injector at weeks 0, 2, 4 and 8, self-administered; the prior IV induction (600 mg at weeks 0, 4, 8) remains an option. Both lead into the same every-eight-week subcutaneous maintenance dose.

What evidence supports it?

Phase 3 AFFIRM (289 patients, 65% advanced-therapy-experienced): 55% CDAI clinical remission versus 30% on placebo, and 44% endoscopic response versus 14% on placebo at week 12 (both p<0.0001).

Did labeling change beyond the new regimen?

Yes — FDA updated the tuberculosis warnings and precautions language in SKYRIZI's prescribing information across all approved indications, not only Crohn's disease.