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Approval rests on the phase 3 AFFIRM trial, in which 56% of patients reached clinical remission at week 12 vs 30% with placebo.
The US Food and Drug Administration (FDA) approved a subcutaneous induction regimen of risankizumab-rzaa (Skyrizi) for adults with moderately to severely active Crohn’s disease, based on phase 3 AFFIRM data, according to AbbVie.¹
In 2022, risankizumab became the first interleukin-23 (IL-23)-specific inhibitor approved for adults with moderately to severely active Crohn’s disease, with induction delivered by intravenous (IV) infusion.² AbbVie submitted its application for subcutaneous (SC) induction in April 2026, offering patients a fully self-administered regimen from treatment initiation.3
“As a physician who has used the SKYRIZI OBI, I’ve seen firsthand the convenience it can offer patients,” said Millie D. Long, MD, MPH, chief of the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill and lead investigator of AFFIRM. “Now with this approval, patients can start treatment at home and continue the same way through maintenance.”
AFFIRM was a global, randomized, double-blind, placebo-controlled phase 3 trial evaluating SC risankizumab as induction therapy in adults with moderately to severely active Crohn’s disease.1 Investigators randomized 274 patients 2:1 to risankizumab 720 mg SC at weeks 0, 2, 4, and 8 or placebo. Approximately 65% of participants had previously failed advanced therapy.¹
Risankizumab met both co-primary endpoints at week 12. Clinical remission, defined as a Crohn’s Disease Activity Index (CDAI) score < 150, occurred in 56% of patients receiving risankizumab (n = 180) vs 30% receiving placebo (n = 94; P <.001).¹ Endoscopic response, defined as a > 50% reduction from baseline in the Simplified Endoscopic Activity Score for Crohn’s Disease (SES-CD), occurred in 43% vs 15%, respectively (P <.001).¹
According to AbbVie, results were strongest among patients without prior advanced therapy failure. In this advanced therapy-naive subgroup, 74% of patients receiving risankizumab (n = 65) achieved clinical remission vs 27% receiving placebo (n = 33), and endoscopic response rates were 60% vs 15%.¹
Among patients with prior advanced therapy failure, clinical remission rates were 45% with risankizumab (n = 115) vs 31% with placebo (n = 61). Endoscopic response rates in this subgroup were 33% vs 15%.¹
SC risankizumab also met secondary endpoints at week 12, including endoscopic remission and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scores vs placebo.¹ Endoscopic remission, defined as an SES-CD ≤4 with ≥ 2-point reduction from baseline and no subscore >1, occurred in 26% of patients receiving risankizumab vs 11% with placebo (P <.001).¹ In the advanced therapy-naive subgroup, endoscopic remission rates reached 43% vs 9%.¹
AbbVie reported the safety profile of SC induction was generally consistent with the known profile of risankizumab in Crohn’s disease, with no new safety risks observed.¹ Labeled warnings include serious hypersensitivity reactions, infections, and hepatotoxicity, with liver testing recommended before treatment, during treatment, and through at least 12 weeks in patients with Crohn’s disease or ulcerative colitis.¹
The FDA also approved a label update across all risankizumab indications, allowing clinicians to determine the need for tuberculosis (TB) evaluation before treatment initiation based on clinical judgment.¹ According to AbbVie, TB testing is not mandatory before starting risankizumab.¹
“With the approval of subcutaneous induction, we are building on the strong efficacy of SKYRIZI while giving patients and physicians greater flexibility in how treatment is initiated,” said Roopal Thakkar, MD, executive vice president of research and development and chief scientific officer at AbbVie.
Patients retain the option of IV induction with 600 mg at weeks 0, 4, and 8.¹ Under either induction route, maintenance dosing begins at week 12 with an on-body injector (OBI) every 8 weeks.¹ The OBI has been available for Crohn’s disease maintenance since 2022; in a real-world survey of 186 patients with Crohn’s disease, 88% reported the device was easy to use.¹
AFFIRM continues with a 12-week blinded or open-label period based on week 12 response, followed by a 52-week open-label extension on approved maintenance dosing.³ Risankizumab is also approved for ulcerative colitis, plaque psoriasis, and psoriatic arthritis.¹
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