AbbVie Announces Phase 3 AFFIRM study successfully met its co-primary and ranked secondary endpoints, demonstrating that SKYRIZI® (risankizumab) delivered via subcutaneous (SC) induction is superior to placebo in inducing clinical remission and endoscopic response in adults with moderately to severely active Crohn’s disease (CD). These results are significant as they establish the efficacy of an SC-only induction pathway, potentially offering a more flexible administration option for patients compared to traditional intravenous (IV) induction.
Study Overview and Methodology
- Study Name: AFFIRM (NCT06063967)
- Design: Global, Phase 3, randomized, double-blind, placebo-controlled.
- Population: 289 adult patients with moderately to severely active Crohn’s disease.
- Patient Profile: 65% of the population was “treatment-refractory” (had failed at least one advanced therapy). 50% had failed two or more advanced therapies.
- Treatment Arms: Patients were randomized 2:1 to receive either risankizumab (SC) or a placebo.
- Primary Endpoints: 1. Clinical Remission: Defined by a Crohn’s Disease Activity Index (CDAI) score < 150. 2. Endoscopic Response: Defined as a >50% reduction in SES-CD from baseline.
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Key Efficacy Results (Week 12)
Risankizumab SC induction showed statistically significant superiority over placebo across all evaluated groups at the 12-week mark.
| Metric | Risankizumab SC | Placebo | P-Value |
| Clinical Remission (Overall) | 55% | 30% | < 0.0001 |
| Endoscopic Response (Overall) | 44% | 14% | < 0.0001 |
| Clinical Remission (Bio-Naïve) | 73.1% | 27.3% | Significant |
| Clinical Remission (Prior Bio-Failure) | 45.2% | 30.8% | Significant |
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Clinical Significance & Market Impact
Innovation in Administration: Most current biologics for Crohn’s disease require an initial intravenous (IV) loading dose in a clinical setting. The AFFIRM study validates a subcutaneous-only induction regimen. This shift could:
- Increase patient convenience by allowing home-based or simplified administration.
- Reduce the burden on infusion centers.
- Provide a competitive edge for AbbVie in the immunology market against other IL-23 and TNF inhibitors.
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