By week 12, 27.7% of Crohn’s patients taking AbbVie’s SKYRIZI had little to no gut inflammation, vs. 10.2% on placebo.
AbbVie's SKYRIZI showed higher rates of endoscopic remission and ulcer-free endoscopy in Crohn's disease patients at weeks 12 and 24 compared to placebo, according to the AFFIRM Phase 3 trial. The results support FDA approval for a subcutaneous induction regimen. SKYRIZI is already approved for other autoimmune conditions.
How this was made
The 30-second read
Why it matters
The data support a regulatory filing for a new subcutaneous induction regimen, potentially expanding AbbVie's market share in gastro‑enterology.
Market read
First disclosure of positive Phase 3 results for a Crohn's indication, likely to move AbbVie's share price.
What to watch
The trial size is modest; long-term safety and comparative efficacy versus existing therapies remain uncertain.
Background
The AFFIRM Phase 3 study evaluated subcutaneous SKYRIZI (risankizumab) in moderate to severe Crohn's disease, reporting endoscopic remission and ulcer‑free rates at weeks 12 and 24.
Ticker impact
AbbVie reported Phase 3 AFFIRM trial results showing 27.7% endoscopic remission at week 12 for SKYRIZI versus 10.2% for placebo.
potential upward pressure as investors price in higher likelihood of regulatory approval and expanded indication.
The data are a first-time disclosure of statistically superior efficacy, a material catalyst for a marketed biologic.
Market effects
Biotech sector may see increased interest in IL-23 inhibitors and other Crohn's disease therapies.
U.S. biotech stocks could benefit; European markets less affected.
Global investors tracking AbbVie's pipeline may adjust exposure to immunology assets.
Counterpoint
If the FDA raises concerns about safety or requires larger trials, the initial enthusiasm could reverse.
Key entities
- CompanyAbbVie
Pharmaceutical company developing SKYRIZI.
- DrugSKYRIZI
IL‑23 inhibitor under investigation for Crohn's disease.