Last updated: May 28, 2026

AbbVie published Phase 3 trial data comparing risankizumab (brand name Skyrizi) to ustekinumab (Stelara) in adults with moderate-to-severe Crohn’s disease who had already failed anti-TNF therapy. The headline result: more patients achieved remission on risankizumab than on ustekinumab at 48 weeks.

Risankizumab is already FDA-approved for Crohn’s disease. This particular study is a head-to-head comparison against ustekinumab — another approved biologic — providing trial-level data on how the two drugs perform against each other in a population that represents a significant portion of treatment-refractory Crohn’s patients.

What the Trial Showed

The study population was adults with moderate-to-severe Crohn’s who had failed or lost response to anti-TNF biologics (like Remicade, Humira, or Cimzia). This is a specific and important population: patients who have already been through a line of treatment, found it insufficient, and need a second-line option.

At week 48:

• More patients on risankizumab achieved clinical remission than those on ustekinumab
• The comparison was direct — same study, randomized, head-to-head

The study also looked at the delivery method. Risankizumab can be administered via an on-body injector that patients use at home. Patient-reported data from the study indicated that the self-injection approach contributed to confidence in managing treatment. That’s a practical element worth noting — for patients who’ve had to build their schedule around infusion appointments, home administration is a meaningful difference.

The source reporting is from TipRanks. The primary trial data is published through AbbVie’s clinical trial program.

The Mechanism Difference

I’ve been on biologics since 2003 — Remicade (infliximab) for 23 years. When I started, anti-TNF drugs were the main option for moderate-to-severe Crohn’s. Since then the field has added IL-12/23 inhibitors (ustekinumab blocks both IL-12 and IL-23), and more selective IL-23 inhibitors like risankizumab (which blocks only IL-23).

The IL-23 pathway is increasingly understood as a central driver in Crohn’s inflammation specifically. Risankizumab’s selectivity for IL-23 over IL-12 is a mechanistic distinction worth understanding: ustekinumab hits both pathways; risankizumab targets just IL-23. Whether that selectivity translates to meaningfully better outcomes in all patients is what this kind of head-to-head data is designed to answer.

For anti-TNF failures specifically, this data is useful. It tells gastroenterologists something they couldn’t conclude from single-arm trials alone — not just that risankizumab works in this population, but that it appears to work better than the other available option in the same population.

What This Doesn’t Tell Us

Head-to-head Phase 3 data is the strongest form of trial evidence, but a few things remain open:

• Long-term safety data beyond 48 weeks. The trial showed 48-week outcomes; longer-term safety and maintenance of remission will come from extension studies and post-market data.
• Individual response variability. More patients achieved remission on risankizumab — that doesn’t mean every patient does. The data shows a population-level advantage, not a guarantee for any individual.
• Patients who failed both anti-TNF and anti-IL-23 therapy represent a harder problem not addressed by this study.

Why This Matters for Patients Cycling Through Biologics

When I look back at my own treatment history, the moments that actually changed my care were driven by head-to-head trial data showing one drug genuinely outperformed another in patients like me. Data like this — comparing two approved drugs in a population of anti-TNF failures — is the kind of information that should be part of a conversation with your GI about whether a switch makes sense.

Risankizumab is available now, for Crohn’s, with an approved indication. If you’ve failed anti-TNF therapy and are on ustekinumab without achieving remission, or are considering what to try next, this trial data is a legitimate point to raise with your gastroenterologist. It doesn’t make the decision for either of you, but it’s the kind of evidence that moves the conversation forward.

The on-body injector piece is practically useful for patients whose work or family schedules make infusion center visits a burden. It won’t matter to everyone, but for some patients it’s a real factor in adherence and quality of life.

Nothing here is medical advice. Biologic selection is a complex decision that depends on your specific disease history, insurance coverage, and GI’s assessment. Always make treatment decisions in consultation with your gastroenterologist.