FDA Approves Subcutaneous Induction for Risankizumab in Crohn's Disease. The Label's TB Testing Language Also Changed.
Adults with moderately to severely active Crohn's disease can now start risankizumab (Skyrizi) with an at-home on-body injector instead of IV infusion, after AbbVie's Oct. 23 approval. The label now leaves pretreatment tuberculosis testing to clinical judgment across all indications.
The Food and Drug Administration has approved a subcutaneous induction regimen of risankizumab (Skyrizi, AbbVie) for adults with moderately to severely active Crohn's disease, letting patients begin treatment at home with an on-body injector, AbbVie announced on Oct. 23. Intravenous induction remains available.
The same action revised the label's tuberculosis warning across every Skyrizi indication, a change that touches dermatology and rheumatology as well as gastroenterology.
What is the new regimen?
Subcutaneous induction is 720 mg by on-body injector at weeks 0, 2, 4 and 8. The intravenous alternative is 600 mg at weeks 0, 4 and 8. Either is followed by on-body injector maintenance every eight weeks starting at week 12, according to the company.
The on-body injector was first introduced in 2022 for Crohn's maintenance, and AbbVie filed the induction application on April 27, Pharmaceutical Executive reported.
What did AFFIRM show?
The approval rests on AFFIRM (NCT06063967), a phase 3, randomized, double-blind, placebo-controlled trial that assigned 274 patients 2:1 to subcutaneous risankizumab (n = 180) or placebo (n = 94). About 65 percent had previously failed an advanced therapy. The co-primary endpoints at week 12 were clinical remission (Crohn's Disease Activity Index below 150) and endoscopic response, scored by a central reader.
Clinical remission was 56 percent versus 30 percent, endoscopic response 43 percent versus 15 percent and endoscopic remission 26 percent versus 11 percent, each P<.001 in the total population. In patients with prior advanced-therapy failure, remission was 45 percent versus 31 percent; in advanced-therapy-naive patients, 74 percent versus 27 percent. AbbVie reported no P values for the subgroups, and the naive group was small (65 versus 33 patients). Pharmaceutical Executive noted that the earlier intravenous induction trials, ADVANCE and MOTIVATE, enrolled different populations, so their remission rates are not directly comparable.
AbbVie said induction safety was consistent with the known Crohn's profile, with no new risks identified. The label retains warnings for hypersensitivity, infections and hepatotoxicity, with liver blood tests before, during and up to at least 12 weeks of treatment.
The efficacy numbers are placebo-controlled and look familiar. The practical change is where induction happens and what the label now asks before the first dose.
What changed on tuberculosis?
The revised warning, approved across all indications, advises considering tuberculosis evaluation before treatment based on clinical judgment; it does not require a test before starting, according to AbbVie and Pharmaceutical Executive; AbbVie's release says there is "no mandatory TB test prior to initiating SKYRIZI." Payer and institutional policies may still require screening regardless of the label.
Millie D. Long, M.D., M.P.H., chief of gastroenterology and hepatology at the University of North Carolina at Chapel Hill and AFFIRM's lead investigator, said in AbbVie's announcement: "Now with this approval, patients can start treatment at home and continue the same way through maintenance."
What practices should do now
For gastroenterology practices, home induction shifts work from the infusion chair to injector training, specialty pharmacy coordination and benefit verification, which may fall under the pharmacy rather than the medical benefit. Check how your main payers will cover the induction pack before the first patients ask. Practices that relied on infusion revenue for Skyrizi induction should expect that volume to change. Dermatology and rheumatology offices should update their pre-biologic checklists to reflect the new tuberculosis language, while keeping any screening their own policy or payers require. For another recent move to at-home biologic dosing, see the satralizumab approval.
Reported, fact-checked and edited by The Script Pad's editorial staff. See How we use AI.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
