AFFIRM: Risankizumab (Skyrizi) Subcutaneous Induction Achieves Primary Endpoints in Crohn’s Disease

AbbVie has announced positive topline results from the phase 3, randomized, placebo-controlled, double-blind AFFIRM study evaluating the efficacy and safety of risankizumab (Skyrizi) subcutaneous (SC) induction treatment versus placebo in adult patients with moderately to severely active Crohn's disease (CD).

As described in the March 2, 2026, press release from the Company, AFFIRM study results showed significantly greater proportions of patients treated with risankizumab SC induction achieved the co-primary endpoints of Crohn's Disease Activity Index (CDAI) clinical remission and endoscopic response at week 12 compared to placebo. Of note, among patients with clinical response after 12 weeks of risankizumab SC induction treatment followed by 12 weeks of maintenance, 67% achieved CDAI clinical remission at week 24 and 57% achieved endoscopic response at week 24.

"Crohn's disease is a complex, often debilitating condition that affects far more than a patient's digestive health, disrupting work, relationships and daily life," Millie Long, MD, MPH, chief of the division of Gastroenterology and Hepatology at University of North Carolina, Chapel Hill, and lead investigator of the AFFIRM study, said in a statement. "These high endoscopic response rates across populations, in particular among those who have not failed an advanced therapy, demonstrate the potential of subcutaneous induction risankizumab as an effective therapy for Crohn's disease."

Risankizumab is an interleukin (IL)-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases. It is approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.

The efficacy and safety of risankizumab SC as an induction treatment in adult patients with moderately to severely active Crohn's disease was assessed in the global, phase 3, randomized, placebo-controlled, double-blind AFFIRM study. Co-primary endpoints were percentage of participants with CDAI Clinical Remission (CDAI < 150) and percentage of participants with endoscopic response at week 12.

A total of 289 patients were randomly assigned in a 2:1 ratio to risankizumab SC or placebo. Investigators noted key demographics and baseline characteristics were generally balanced between the risankizumab SC and placebo groups, with 65% having failed advanced therapies for the treatment of CD before. Of those patients, 50% failed ≥ 2 advanced therapies, 23% failed ustekinumab, and 12% failed a Janus kinase inhibitor.

AFFIRM consists of 3 treatment periods, including a placebo-controlled Period A (baseline to week 12) to evaluate the efficacy and safety of risankizumab SC induction treatment, an extended Period B (week 12 to 24) where patients receive blinded or open-label treatments based on their clinical response at week 12, and a 52-week open-label extension Period C where all patients receive the approved risankizumab maintenance treatment.

Results showed significantly greater proportions of patients treated with risankizumab SC induction achieved the co-primary endpoints of CDAI clinical remission (55% vs 30%; P <.0001) and endoscopic response (44% vs 14%; P <.0001) at week 12 compared to placebo. Among patients with clinical response after 12 weeks of risankizumab SC induction treatment followed by 12 weeks of maintenance, 67% achieved CDAI clinical remission at week 24 and 57% achieved endoscopic response at week 24.

During the 12-week, double-blind, placebo-controlled period, the safety profile of risankizumab SC was consistent with the safety profile observed in Crohn's disease with no new safety risks observed. The most common adverse events observed among patients receiving risankizumab were upper respiratory tract infection, abdominal pain and arthralgia. Serious adverse events occurred in 0.5% of patients in the risankizumab SC group compared to 3.1% in the placebo group.

AbbVie described plans to publish full results in an upcoming medical journal and additionally share them at future medical congresses.

"This study evaluated a difficult-to-treat Crohn's disease patient population, including a majority with a prior failure to advanced therapy, and these data reinforce risankizumab as a leading, effective treatment for patients," said Kori Wallace, MD, PhD, vice president, global head of immunology clinical development at AbbVie. "The level of endoscopic response is a particularly meaningful achievement for Crohn's disease patients; and for AbbVie, these results underscore our continued innovation and research to raise the standard of care."

References

1. AbbVie. AbbVie Announces Positive Topline Results from Phase 3 AFFIRM Study Evaluating SKYRIZI® (Risankizumab) Subcutaneous Induction in Patients with Crohn's Disease. March 2, 2026. Accessed March 2, 2026. https://news.abbvie.com/2026-03-02-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-AFFIRM-Study-Evaluating-SKYRIZI-R-Risankizumab-Subcutaneous-Induction-in-Patients-with-Crohns-Disease

2. Brooks A. FDA Approves Risankizumab (Skyrizi) for Ulcerative Colitis. HCPLive. June 18, 2024. Accessed March 2, 2026. https://www.hcplive.com/view/fda-approves-risankizumab-skyrizi-for-ulcerative-colitis