TOPLINE:

Nearly 60% of patients with refractory Crohn's disease (CD) who initiated risankizumab achieved steroid-free clinical remission both at the short-term and last follow-up. However, patients who were previously exposed to at least three advanced biologic therapies had lower odds of remission than those who were previously exposed to two or fewer biologic therapies.

METHODOLOGY:

• Researchers conducted an observational study using data from the ENEIDA registry to evaluate the real-world effectiveness and safety of risankizumab in refractory CD.
• They included 857 adult patients with refractory CD who initiated risankizumab treatment (mean age at risankizumab initiation, 50.3 years; 59.6% men) across 60 hospitals in Spain. Nearly 50% of patients were exposed to three or more biologic therapies, with 89.6% exposed to anti-TNF and 69.3% exposed to ustekinumab.
• All patients received intravenous risankizumab (600 mg) at 0, 4, and 8 weeks, followed by subcutaneous administration (360 mg) for maintenance every 8 weeks after week 12.
• The primary outcome was steroid-free clinical remission, defined as a Harvey-Bradshaw Index (HBI) score ≤ 4 without systemic corticosteroid use, assessed at 8-12 weeks and at the last follow-up visit.
• The secondary outcome was steroid-free clinical remission according to prior exposure to advanced biologic therapy, specifically the number of previous biologic agents (three or more vs two or fewer) and prior use of ustekinumab.

TAKEAWAY:

• At 8-12 weeks following the initiation of risankizumab, 56.4% of patients achieved steroid-free clinical remission, and 61.2% were in steroid-free clinical remission at the last follow-up.
• Patients who were previously exposed to at least three biologic therapies were less likely to achieve steroid-free clinical remission than those who were previously exposed to two or fewer biologic therapies at the last follow-up (odds ratio [OR], 0.517; P = .003). Increasing age was independently associated with a lower likelihood of remission (OR, 0.987; P = .018).
• In the multivariable analysis, prior exposure to ustekinumab was not linked to steroid-free clinical remission at the last follow-up.
• Adverse events occurred in 7.9% of patients. Treatment discontinuation due to adverse events was reported in 1.4% of the overall cohort and in 17.6% of those with adverse events.

IN PRACTICE:

"RZB [risankizumab] demonstrated clinically meaningful effectiveness in patients with CD treated in routine practice," the authors wrote.

"These findings support the use of RZB as an effective therapeutic option across advanced lines of therapy and suggest that earlier positioning within the treatment sequence may maximize clinical benefit," they added.

SOURCE:

This study was led by Manuel Barreiro-de Acosta, Complexo Hospitalario Universitario de Santiago and Fundación Instituto de Investigación Sanitaria de Santiago de Compostela, Santiago de Compostela, Spain. It was published online on June 10, 2026, in Alimentary Pharmacology and Therapeutics.

LIMITATIONS:

The non-randomised observational design restricted causal inference. Outcome assessment mostly depended on clinical indices, including the HBI, which may have led to interobserver variability and may not have fully captured the inflammatory activity. Endoscopic data were limited to a small group of patients.

DISCLOSURES:

The authors received assistance from Equipo3Datos for statistical analysis, which was funded by the Spanish Working Group in Crohn's Disease and Ulcerative Colitis. The ENEIDA registry was partly funded by AbbVie, Pfizer, Janssen, and Lilly. Several authors declared serving as speakers, consultants, and advisory members or receiving research or education funding or consulting fees from various pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.