AbbVie has submitted a regulatory application to the US Food and Drug Administration (FDA) seeking approval for risankizumab-rzaa (Skyrizi) subcutaneous (SC) induction for adults with moderately to severely active Crohn's disease (CD).¹
The supplemental application, announced on April 27, 2026, is supported by positive data from the phase 3 AFFIRM study.¹ If approved, risankizumab SC induction would offer an alternative to the currently approved intravenous (IV) induction regimen.
"Crohn's disease is a chronic inflammatory condition that affects an estimated 1 million Americans, and its impact often reaches beyond the gut as its unpredictability can impact daily life and emotional health for patients," Kori Wallace, MD, PhD, vice president, global head of immunology clinical development, AbbVie, said in a statement. "AbbVie continues to invest in research and innovative solutions to help elevate the standard of care for patients so that they may live a life unburdened by their Crohn's disease."
Risankizumab became the first interleukin-23 (IL-23) inhibitor approved by the FDA for moderately to severely active CD in 2022.¹ The current label requires IV induction followed by SC maintenance dosing every 8 weeks. An SC induction option would eliminate the need for infusion-center visits during the induction phase, a meaningful logistical consideration for patients and practices alike.
AFFIRM trial design and co-primary endpoints for risankizumab SC induction
According to AbbVie, the AFFIRM study is a global, phase 3, randomized, double-blind, placebo-controlled trial evaluating risankizumab SC induction in adult patients with moderately to severely active CD. A total of 289 patients were randomized in a 2:1 ratio to risankizumab SC or placebo.¹
The enrolled population included both advanced-therapy-naive patients and those with prior advanced therapy failure; 65% of participants had previously failed advanced therapies for CD.¹
The study defined 2 coprimary endpoints:
- Achievement of CDAI clinical remission (CDAI < 150)
- Achievement of endoscopic response, both assessed at week 12
AbbVie reported positive topline results on both co-primary endpoints in March 2026, though the company has not yet disclosed specific effect sizes, response rates, or p-values in the public domain.¹
AFFIRM includes 3 treatment periods. Period A (baseline to week 12) serves as the placebo-controlled induction evaluation. Period B (week 12 to 24) assigns patients to blinded or open-label treatment based on their clinical response at week 12. Period C is a 52-week open-label extension in which all patients receive the approved risankizumab maintenance regimen.¹
Risankizumab safety profile and Crohn's disease dosing flexibility
AbbVie has not released detailed safety data from the AFFIRM study in this announcement. The known safety profile of risankizumab in CD and ulcerative colitis, as described in the current prescribing information, includes upper respiratory infections, headache, joint pain, abdominal pain, injection site reactions, anemia, fever, back pain, urinary tract infection, and rash.² Liver enzyme elevations have been reported during IV induction; a hepatic event with rash leading to hospitalization occurred in a patient with CD receiving IV risankizumab.²
If approved, the SC induction pathway would allow clinicians to offer patients a fully subcutaneous treatment course from induction through maintenance. Patients would choose between SC injection and IV infusion for their induction period, then continue SC maintenance dosing every eight weeks regardless of induction route.¹ AbbVie anticipates FDA approval for the new dosing regimen later in 2026.¹
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