Long-Term Outcomes and Prognostic Factors for Vedolizumab-Treated Japanese Patients with Ulcerative Colitis

Vedolizumab (VDZ) has been available for Japanese patients with ulcerative colitis (UC). However, real-world data regarding the long-term efficacy and safety of VDZ in Japanese patients with active UC remain limited. This study aimed to evaluate the long-term outcomes of VDZ and identify prognostic factors in Japanese patients with UC.

This retrospective multicenter cohort study was conducted at six hospitals and one clinic in Hokkaido, Japan. A total of 172 patients with UC who received VDZ treatment between November 2018 and October 2022 were included. Treatment persistence rates at 52, 104, and 156 weeks were evaluated. The median follow-up duration was 51 weeks (range: 1-156). Clinical response, clinical remission, and mucosal healing rates were assessed at weeks 6 and 52. Prognostic factors for treatment response were analyzed using univariate and multivariate logistic regression analyses.

The cumulative treatment persistence rates at weeks 52, 104, and 156 were 68.1%, 58.1%, and 50.7%, with 64, 32, and 17 patients remaining on VDZ at those respective weeks. Clinical response and remission rates at week 6 were 63.3% and 52.3%, while clinical remission, corticosteroid-free remission, and mucosal healing rates at week 52 were 59.3%, 53.9%, and 52.3%, respectively. Multivariable analysis identified male sex and absence of prior anti-tumor necrosis factor (TNF) exposure as factors associated with clinical response at week 6 (odds ratio [OR] 2.17, p = 0.045; OR 2.26, p = 0.046). Clinical response at week 6 was strongly associated with clinical remission at week 52 (OR 14.5, p < 0.01). Among patients previously treated with anti-TNF agents, those with secondary loss of response had significantly higher remission rates at week 52 than did those with primary non-response (p < 0.01). Adverse events were observed in 6 patients, with one case leading to treatment discontinuation; no severe adverse events were reported.

VDZ demonstrated favorable long-term treatment persistence, efficacy, and safety in Japanese patients with UC. The efficacy of VDZ may vary depending on prior anti-TNF therapy outcomes, particularly the reasons for discontinuation. These findings provide valuable insights for optimizing treatment strategies in UC patients, although further prospective studies are warranted.