SKYRIZI Outperforms Stelara in Landmark Crohn's Disease Trial: What the SEQUENCE Results Mean

Head-to-Head Comparison Shows Risankizumab Superiority

AbbVie’s latest clinical data reveals a significant advance in Crohn’s disease treatment. The Phase 3 SEQUENCE trial—a rigorously designed head-to-head study—directly compared risankizumab (SKYRIZI) against ustekinumab (Stelara) in patients with moderate-to-severe active Crohn’s disease who had previously failed one or more anti-TNF therapies. For patients exhausted conventional treatment options, this comparison addresses a critical clinical question: which biologic delivers better outcomes?

Primary Endpoints: Where SKYRIZI Wins

The trial established two primary efficacy measurements. First, risankizumab achieved non-inferiority for clinical remission by week 24, measured using the Crohn’s Disease Activity Index (CDAI). This means patients receiving SKYRIZI reached remission rates comparable to or exceeding those on Stelara—a crucial benchmark for earlier symptom relief.

More notably, risankizumab demonstrated superiority in endoscopic remission at week 48. Endoscopic assessment—direct visualization of the intestinal lining—represents the gold standard for confirming true disease resolution. The SKYRIZI vs Stelara comparison here wasn’t just equivalent; risankizumab showed measurable advantage in healing mucosal tissue, suggesting deeper and more sustained remission.

Secondary Endpoints and Safety Profile

Beyond primary objectives, all secondary efficacy endpoints favored risankizumab with statistical significance. The drug regimen—600 mg intravenous induction dosing at weeks 0, 4, and 8, followed by 360 mg subcutaneous maintenance every 8 weeks starting at week 12—proved both effective and well-tolerated. Safety monitoring revealed no novel adverse signals, with the tolerability profile consistent with risankizumab’s established safety record across other indications.

This contrasts with Stelara’s administration schedule (intravenous induction at week 0 and 90 mg subcutaneous every 8 weeks), offering flexibility for patient preferences and clinical management strategies.

Clinical Significance for Anti-TNF Experienced Patients

The SEQUENCE trial specifically enrolled patients with documented anti-TNF failure—a challenging population representing treatment-resistant disease. In this real-world scenario, demonstrating superiority rather than mere equivalence strengthens the evidence base for treatment sequencing decisions and provides gastroenterologists with data-driven confidence in choosing risankizumab over established alternatives.