Risankizumab Performs Well in Real-World Crohn’s Disease—even After Ustekinumab (ARISE-CD): BMJ Open | August 2026

Introduction:

Risankizumab, an IL-23 p19 inhibitor, is established for moderately to severely active Crohn’s disease based on phase III trials. ARISE-CD examined how well it performs in routine practice, particularly in a difficult-to-treat population with substantial prior exposure to advanced therapies.

Why was this study needed?

Real-world effectiveness data for risankizumab remain limited.

Many patients starting risankizumab have already failed multiple biologic or advanced therapies.

An important practical question is whether prior ustekinumab exposure reduces subsequent response to selective IL-23 blockade.

Results:

131 patients from 9 NHS hospitals were included.

Median prior advanced therapies: 2.

90% had prior anti-TNF exposure.

56% had previously received ustekinumab.

6-month treatment persistence: 91%.

Steroid-free persistence: 84%.

Among patients with available clinical data, 67% achieved steroid-free clinical remission at 6 months.

Biochemical remission occurred in 38%.

In paired analyses, both inflammatory biomarkers improved:

CRP: 6 → 4 mg/L

Faecal calprotectin: 201 → 141 µg/g

Prior ustekinumab exposure did not significantly reduce treatment persistence, clinical remission, or biochemical remission.

No new safety signals were identified.

Clinical Impact:

The most useful message is that prior exposure to ustekinumab does not appear to preclude benefit from risankizumab.

That supports an increasingly important therapeutic distinction:

Ustekinumab = IL-12/23 p40 blockade

Risankizumab = selective IL-23 p19 blockade

Failure of the former therefore does not necessarily imply failure of the latter.

This is particularly relevant in heavily pretreated Crohn’s disease, where preserving additional effective mechanisms is clinically valuable.

Caution:

This was a retrospective observational study, and remission analyses were based only on patients with available HBI/CDAI or paired biomarker data. Endoscopic outcomes were not the primary focus, so these findings should not be interpreted as proof of mucosal healing.

Bottom Line:

Risankizumab showed high 6-month persistence and meaningful clinical and biochemical effectiveness in a heavily pretreated real-world Crohn’s disease cohort. Importantly, prior ustekinumab exposure did not appear to diminish benefit, supporting risankizumab as a viable option even after previous IL-12/23 therapy.