Ustekinumab and vedolizumab are efficacious for preventing postoperative recurrence among patients with Crohn disease (CD) who are at high risk, according to study results published in Digestive and Liver Disease.
Data for this retrospective, multicenter, observational, nationwide study were sourced from the ENEIDA registry, which collected data in Spain between 2015 and 2019. Patients (N=65) with CD who underwent curative intestinal resection and initiated ustekinumab (n=40) or vedolizumab (n=25) within the first 3 months postintervention were evaluated for clinical or surgical postoperative recurrence.
The ustekinumab and vedolizumab cohorts comprised 62% and 60% men; had a mean age of 34 (95% CI, 24-55) and 38 (95% CI, 31-62) years; the time between diagnosis and surgery was 160 (95% CI, 39-280) and 149 (95% CI, 34-260) months; and the majority of patients had ileocolonic disease (62% vs 60%) respectively. While the vedolizumab vs ustekinumab cohort had more penetrating disease behavior (52% vs 37%, respectively), the ustekinumab cohort had more inflammatory (32% vs 20%), stricturing (30% vs 28%), and perianal disease (27% vs 24%) behavior. All patients were exposed to antitumor necrosis factor therapies prior to surgery.
The vedolizumab recipients started therapy sooner following operative procedures compared with the ustekinumab group (mean, 23 vs 31 days; P <.001), respectively.
The cumulative probability of clinical postoperative recurrence at 12 months following operative procedures for the ustekinumab with vedolizumab cohorts was 32% and 30%, and endoscopic postoperative recurrence at follow-up was 42% and 40%, among whom 27% and 20% had significant endoscopic postoperative recurrence, respectively.
Six (15%) ustekinumab recipients discontinued treatment due to postoperative recurrence, and 1 patient underwent additional intestinal resection. Five (20%) vedolizumab recipients discontinued treatment due to postoperative recurrence or extraintestinal manifestations, and 2 underwent additional resection.
In the univariate analysis, endoscopic postoperative recurrence was associated with perianal disease (P =.01), and no factors were associated with clinical postoperative recurrence. No other significant trends were observed.
Study limitations include the retrospective design, small sample size, and a lack of endoscopic assessment during follow-up.
“Our preliminary data support the notion that vedolizumab and ustekinumab might be effective and safe for the prevention of POR [postoperative recurrence], with observed endoscopic POR [postoperative recurrence] rates close to those reported for anti-TNF agents,” the study authors wrote. “These results warrant the performance of prospective, controlled clinical trials to assess the real efficacy of both drugs in this clinical setting.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Mañosa M, Fernández-Clotet A, Nos P, et al. Ustekinumab and vedolizumab for the prevention of postoperative recurrence of Crohn’s disease: Results from the ENEIDA registry. Dig Liver Dis. Published online August 7, 2022. doi:10.1016/j.dld.2022.07.013