AbbVie’s Phase 3 AFFIRM trial found higher clinical remission and endoscopic response with subcutaneous SKYRIZI than placebo in Crohn’s disease at Week 12.
Written By: Anamika Koshti, PharmD
Reviewed By: Pharmacally Editorial Team
AbbVie announced on October 11, 2026, that it is presenting 22 abstracts from its inflammatory bowel disease portfolio at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting in Nashville, Tennessee, held October 9–14. The program includes Phase 3 AFFIRM data evaluating subcutaneous (SC) SKYRIZI (risankizumab-rzaa) induction in Crohn’s disease, long-term risankizumab analyses and real-world evidence for RINVOQ (upadacitinib). The AFFIRM oral presentation is scheduled for October 13.
Together, these findings examine a potential alternative induction route for risankizumab and provide additional evidence on treatment outcomes in patients with inflammatory bowel disease.
AFFIRM supports subcutaneous induction in Crohn’s disease
AFFIRM (NCT06063967) randomized 289 adults with moderately to severely active Crohn’s disease in a 2:1 ratio to receive subcutaneous risankizumab or placebo. In March 2026, AbbVie reported that the Phase 3 study met both co-primary endpoints at Week 12.
Clinical remission, measured using the Crohn’s Disease Activity Index (CDAI), occurred in 55% of patients receiving risankizumab compared with approximately 30% receiving placebo. Endoscopic response was achieved by 44% and approximately 14%, respectively. Both comparisons were statistically significant, with p-values below 0.0001.
Among patients who responded clinically at Week 12, 67% achieved clinical remission and 57% achieved endoscopic response at Week 24. These results apply to the clinical-responder subgroup, rather than the entire randomized population.
The findings support further evaluation of a fully subcutaneous induction regimen. Risankizumab is currently initiated with intravenous induction for Crohn’s disease, followed by subcutaneous maintenance. AbbVie submitted an application to the US Food and Drug Administration for subcutaneous induction on April 27, 2026. The application remains distinct from an FDA approval decision.
Treatment history influenced the magnitude of response
Approximately 65% of AFFIRM participants had previously failed at least one advanced therapy, making the study relevant to a population with substantial prior treatment exposure.
Among advanced-therapy-naive patients (n=100), clinical remission at Week 12 was 73.1% with risankizumab versus 27.3% with placebo. Endoscopic response was 61.2% versus 15.2%, an absolute difference of 46 percentage points.
Among patients with prior advanced-therapy failure (n=189), clinical remission occurred in 45.2% versus 30.8%, while endoscopic response occurred in 34.7% versus 13.8%. The absolute difference in endoscopic response was therefore 20.9 percentage points.
The numerical advantage persisted in patients with prior treatment failure, although the separation between treatment groups was smaller than in advanced-therapy-naive patients. These subgroup findings suggest that treatment history may influence the magnitude of response, but they do not independently establish comparative efficacy between patient subgroups.
Long-term analyses extend the evidence base
AbbVie also reported long-term findings from several studies. Open-label extension analyses from FORTIFY (NCT03105102) showed sustained outcomes through 144 weeks across ileal, colonic and ileocolonic Crohn’s disease.
A post hoc FORTIFY analysis found that 74.5% of patients with fistulizing Crohn’s disease had no draining fistulas after five years. In SEQUENCE (NCT04524611), patients with prior anti-TNF failure maintained clinical and endoscopic efficacy through 148 weeks, with endoscopic outcomes in ileal disease becoming comparable to those in other disease locations.
Separately, the COMMAND study (NCT03398135) reported sustained improvements over three years among patients with ulcerative colitis, regardless of prior advanced-therapy exposure.
These findings add information about longer-term outcomes but require cautious interpretation. Open-label extension analyses lack a concurrent randomized comparator, while the fistula findings come from a post hoc analysis. They therefore describe observed outcomes over time rather than establishing comparative treatment benefit.
An anchored matching-adjusted indirect comparison also reported higher endoscopic response with subcutaneous risankizumab than with guselkumab during induction. Because this was an indirect comparison rather than a head-to-head trial, the finding should not be interpreted as definitive evidence of superiority.
Real-world RINVOQ findings address complex disease
The conference program also includes real-world analyses of upadacitinib in patients with Crohn’s disease.
In the Veterans Affairs health system analysis, 93.3% of patients with fistulizing disease and 76.9% with stricturing disease who remained on treatment achieved clinical and corticosteroid-free remission. These estimates describe patients who continued treatment and may not represent outcomes among all patients who initiated therapy.
In a separate Department of Defense analysis, patients with isolated ileal disease had clinical remission of 57%, endoscopic response of 58% and endoscopic remission of 53.6% at six months.
These observations provide additional information about treatment outcomes in routine-care populations. However, without complete sample sizes, eligibility criteria and methodological details, the findings cannot establish comparative effectiveness or be directly compared with the controlled AFFIRM results.
Implications for treatment evidence
The ACG 2026 program presents three distinct evidence streams: controlled Phase 3 results supporting subcutaneous risankizumab induction, longer-term analyses describing the durability of risankizumab outcomes, and real-world observations involving upadacitinib.
The AFFIRM results provide the clearest comparative evidence because they derive from a randomized, placebo-controlled trial. The extension and real-world findings add clinical context but carry different methodological limitations. The extent to which subcutaneous induction may change clinical practice will depend on regulatory review and the evidence available to support its use.
Reference
New SKYRIZI® (risankizumab-rzaa) and RINVOQ® (upadacitinib) Data Demonstrate Disease Control for Patients Living with Inflammatory Bowel Disease, AbbVie, 11 October 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
About the Writer
Anamika Koshti (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, and evidence-based medicine. She has authored peer-reviewed publications on Alzheimer’s disease and PCOS, presented research at national conferences, and gained hands-on experience in medical content development and clinical data interpretation. She is committed to translating complex medical research into accurate, accessible content for healthcare professionals and patients.