TOPLINE:

Among patients with Crohn's disease, risankizumab yielded significant improvements in clinical and endoscopic outcomes and had a favourable safety profile; prior ustekinumab exposure was associated with lower clinical remission at week 12.

METHODOLOGY:

• Researchers conducted a retrospective study across 28 Italian centres and enrolled 520 adult patients with Crohn's disease (mean age, 47.5 years; 44.4% women) who initiated risankizumab treatment between September 2023 and March 2025 and had at least 12 weeks of follow-up.
• Patients had prior exposure to advanced therapies (ADTs), with 71.7% not responding to two or more ADTs, 50.8% not responding to three or more ADTs, and 54.8% previously exposed to ustekinumab.
• All patients received intravenous risankizumab 600 mg at weeks 0, 4, and 8, followed by subcutaneous administration 360 mg every 8 weeks starting at week 12; clinical, endoscopic, radiologic, laboratory, and safety data were recorded at weeks 12, 26, and 52.
• Co-primary outcomes were steroid‑free clinical remission, defined as a Harvey-Bradshaw Index score < 5 without systemic corticosteroids or budesonide, assessed at week 12 and endoscopic remission — a simple endoscopic score for Crohn's disease of 0-2 or a Rutgeerts score of i0-i1 for postoperative patients with neoterminal ileal inflammation — assessed at week 52.
• Secondary outcomes included steroid-free clinical remission at weeks 26 and 52; clinical remission at weeks 12, 26, and 52; and biochemical steroid-free clinical remission (steroid-free clinical remission with C-reactive protein levels < 5 mg/L) at weeks 12, 26, and 52.

TAKEAWAY:

• By week 12, 60.8% of patients achieved steroid‑free clinical remission and 63.9% met the criteria for clinical remission. At week 52, 65.6% of patients maintained steroid-free clinical remission, 68.8% were in clinical remission, and 37.5% achieved endoscopic remission.
• At week 12, patients without vs with prior ustekinumab exposure were more likely to achieve clinical remission (73.6% vs 55.8%) and steroid-free clinical remission (69.8% vs 53.3%; P < .001 for both). Similar findings were noted for endoscopic remission at week 52.
• Prior ustekinumab exposure was associated with lower clinical remission at week 12 (adjusted odds ratio, 0.61; P = .021). The proportion of patients achieving composite biochemical plus steroid‑free clinical remission increased from 36.7% at week 12 to 45.2% at week 26 and 49.4% at week 52.
• The safety profile of risankizumab was favourable; adverse events occurred in 6.9% of patients, and discontinuations noted in six patients because of adverse events.

IN PRACTICE:

"In UST [ustekinumab]-naive patients and in those with fewer prior failures, earlier positioning of RZB [risankizumab] may maximize the probability of achieving objective healing targets, whereas in more heavily pretreated or UST-exposed patients, RZB remains a reasonable and effective option, although with more modest expectations for deep endoscopic or transmural remission and the need for closer objective monitoring," the authors of the study wrote.

SOURCE:

This study was led by Franco Scaldaferri, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy. It was published online on February 18, 2026, in The Americal Journal of Gastroenterology.

LIMITATIONS:

The study was retrospective in nature and drawn from tertiary referral centres, which introduced potential referral and selection biases and limited causal inference. The timing of endoscopy and imaging assessments varied. The inclusion of a selected subgroup of patients undergoing follow-up endoscopy or imaging may have either underestimated or overestimated true endoscopic and radiologic effectiveness.

DISCLOSURES:

This study did not receive any external funding. Several authors reported receiving consultancy and lecture fees or sponsorship for participation in conferences and being advisory board members of various pharmaceutical companies, including Takeda, AbbVie, Lilly, MSD, and Pfizer.

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