Long-term clinical and endoscopic efficacy of vedolizumab and therapeutic persistence in patients with ulcerative colitis in China: a multicenter observational study

Background/Aims: Limited data are available on the long-term efficacy of vedolizumab (VDZ) in Asian patients with ulcerative colitis (UC), particularly regarding endoscopic outcomes. Methods: In this multicenter, retrospective, real-world study, UC patients treated with VDZ were evaluated for steroid-free remission, endoscopic remission (Mayo endoscopic score ≤ 1), and mucosal healing (Mayo endoscopic score = 0) at weeks 52, 104, and 156. Treatment persistence was analyzed using Kaplan-Meier curves. Results: Among 239 patients, steroid-free remission was achieved in 59.4%, 52.9%, and 40.3% at weeks 52, 104, and 156, respectively. Endoscopic remission and mucosal healing rates were 53.3% and 32.2% at week 52, 39.8% and 27.5% at week 104, and 34.8% and 26.2% at week 156. The probability of treatment persistence was 76.8%, 63.3%, and 56.4% at these time points. Anti-tumor necrosis factor (anti-TNF) exposure was independently associated with a higher risk of failing to achieve long-term VDZ persistence (hazard ratio [HR], 2.754; 95% confidence interval [CI], 1.478-5.135; P= 0.001), whereas achieving early steroid-free remission after induction was an independent protective factor (HR, 0.480; 95% CI, 0.235-0.978; P= 0.043). VDZ-related adverse events occurred in 7.1% of patients, with no serious events reported. Conclusions: VDZ demonstrated long-term clinical and endoscopic efficacy with a high safety profile in Chinese UC patients. Notably, anti-TNF-naive patients with early steroid-free remission were more likely to maintain long-term treatment persistence.