Treatment with risankizumab results in fast and sustained favourable clinical, endoscopic, and radiologic outcomes in patients with Crohn’s disease (CD), a real-world study has shown.
“Importantly, 1-year effectiveness was similar in patients with two and [three or more] previous failures, supporting risankizumab as a valuable option for a refractory population,” the investigators said.
Five hundred twenty patients with CD completed the 12-week follow-up and were included in the analysis. Of these, 45.0 percent had failed at least three advanced therapies, and 54.8 percent were exposed to ustekinumab. [Am J Gastroenterol 2026;121:2492-2503]
At week 12, 76.5 percent of patients showed clinical response, and 60.8 percent achieved steroid-free clinical remission (SFCR). At week 52, 65.6 percent of patients achieved SFCR, 37.5 percent had endoscopic remission, while 24.6 percent and 9.8 percent achieved radiologic remission and transmural healing, respectively.
Patients without ustekinumab exposure demonstrated superior early clinical outcomes (week-12 SFCR: 69.8 percent vs 53.3 percent) and a higher endoscopic remission rate at week 52 (56.5 percent vs 28.6 percent) compared with exposed individuals.
Notably, the effectiveness of risankizumab at week 52 was similar between patients with two previous advanced therapy failures and those with three or more (69.0 percent vs 63.7 percent; p=0.607).
Extraintestinal manifestations became fewer over time, while perianal disease showed modest improvements. In 213 patients with CD included in the sensitivity cohort, 47 percent achieved SFCR at week 52. Risankizumab use was well-tolerated and did not induce new safety signals.
“Despite this case-mix, induction results were robust: by week 12, clinical remission was 64 percent, SFCR exceeded 60 percent, and clinical response was observed in >75 percent of patients,” the investigators said.
Literature
These findings are comparable to those of the ADVANCE/MOTIVATE trials, the GETAID series, and the US multicentre REBOOT-IBD consortium study but are inferior to that of a single-centre experience showing 70-percent remission by Harvey-Bradshaw Index at week 12. [Lancet 2022;399:2015-2030; Clin Gastroenterol Hepatol 2024;22:2451-2458.e1; J Crohns Colitis 2024;18(suppl_1):i1565]
The current multicentre, retrospective observational study involved adults initiating risankizumab with assessments at weeks 12, 26, and 52. Primary endpoints included week-12 SFCR (Harvey-Bradshaw Index <5 in the absence of systemic corticosteroids or budesonide) and week-52 endoscopic remission (Simple Endoscopic Score-CD 0‒2 or Rutgeerts i0‒i1 postoperatively).
The investigators conducted the main effectiveness analysis as-observed and a preplanned sensitivity analysis including patients expected to reach week-52 before database lock.
“In ustekinumab-naïve patients and in those with fewer previous failures, earlier positioning of risankizumab may maximize the probability of achieving objective healing targets, whereas in more heavily pretreated or ustekinumab-exposed patients, risankizumab 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 investigators said.
“Therefore, our results argue for tailored decision-making that balances previous treatment history, disease phenotype, and therapeutic goals,” they added.
A chronic, multifactorial relapsing-remitting inflammatory disorder of the gastrointestinal tract, CD results in transmural inflammation, progressive tissue damage, and quality of life impairment. Its rising prevalence worldwide may result in healthcare burden. [Lancet 2017;389:1741-1755; Lancet 2017;390:2769-2678]