AbbVie’s SKYRIZI Shows Strong Induction Results in Hard-to-Treat Crohn’s Disease: Phase 3 AFFIRM Data

AbbVie announced positive topline results from the Phase 3 AFFIRM study (NCT06063967), evaluating subcutaneous (SC) risankizumab (SKYRIZI®) as induction therapy versus placebo in adults with moderately to severely active Crohn’s disease (CD).

This double-blind, placebo-controlled trial enrolled 289 patients, randomized 2:1 to risankizumab SC or placebo, focusing on a tough population: 65% were treatment-refractory, with 50% failing two or more advanced therapies, 23% failing ustekinumab, and 12% failing a JAK inhibitor.

Kori Wallace, AbbVie’s vice president, global immunology clinical development said AFFIRM evaluated a refractory CD population with majority prior advanced therapy failure, reinforcing risankizumab as a leading treatment. Endoscopic response levels are especially meaningful, highlighting innovation to elevate standards of care.

At week 12, risankizumab SC induction achieved both co-primary endpoints with high statistical significance over placebo: Crohn’s Disease Activity Index (CDAI) clinical remission (defined as CDAI <150) in 55% of patients versus 30% on placebo (p<0.0001), and endoscopic response (≥50% reduction from baseline in Simple Endoscopic Score for Crohn’s Disease [SES-CD]) in 44% versus 14% (p<0.0001). These outcomes reflect substantial symptom relief and mucosal healing in moderately to severely active Crohn’s disease, critical for long-term prognosis in this Phase 3 AFFIRM population.

Efficacy held strong across subgroups of the 289 patients:

In the advanced therapy-naïve group (N=100), risankizumab SC drove CDAI clinical remission in 73.1% (vs. 27.3% placebo) and endoscopic response in 61.2% (vs. 15.2%);

Among prior advanced therapy failures (N=189, including 50% with ≥2 prior failures), rates were 45.2% (vs. 30.8%) and 34.7% (vs. 13.8%), respectively demonstrating durable benefits even in this refractory majority (65% of total).

Among clinical responders at week 12 who continued to maintenance, 67% achieved CDAI remission and 57% endoscopic response at week 24.

Millie D. Long, AFFIRM lead investigator, added Crohn’s is a debilitating condition disrupting work, relationships, and daily life beyond digestive health.
High endoscopic response rates, particularly in therapy-naïve patients, show SC induction risankizumab’s strong potential.

Safety aligned with prior CD data: common adverse events included upper respiratory infection, abdominal pain, and arthralgia. Serious events were rare (0.5% risankizumab vs. 3.1% placebo); no new signals emerged.

Crohn’s Context and SKYRIZI

Crohn’s disease drives chronic gut inflammation, often worsening to complications like surgery.

SKYRIZI is a humanized IgG1 monoclonal antibody that selectively targets and binds the p19 subunit of interleukin-23 (IL-23), a key cytokine driving chronic immune-mediated inflammation. This high-affinity binding neutralizes IL-23, preventing its interaction with the IL-23 receptor on T-cells and other immune cells, thereby blocking downstream signaling and release of pro-inflammatory mediators like IL-17A, IL-17F, IL-22, and chemokines. It is approved for CD maintenance (and plaque psoriasis, psoriatic arthritis, ulcerative colitis), now shows induction promise.

References

AbbVie Announces Positive Topline Results from Phase 3 AFFIRM Study Evaluating SKYRIZI® (Risankizumab) Subcutaneous Induction in Patients with Crohn’s Disease, 02 March 2026,  AbbVie Announces Positive Topline Results from Phase 3 AFFIRM Study Evaluating SKYRIZI® (Risankizumab) Subcutaneous Induction in Patients with Crohn’s Disease – Mar 2, 2026

A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn’s Disease. (AFFIRM), ClinicalTrials.gov ID NCT06063967, https://clinicaltrials.gov/study/NCT06063967\