Development and Validation of a Scoring System to Predict 2-Year Clinical Remission in Ulcerative Colitis Patients on Vedolizumab.

BACKGROUND AND AIMS

Vedolizumab is s gut-selective advanced therapy that is safe and efficacious for the treatment of ulcerative colitis (UC). Once patients achieve successful induction, there is a risk of loss of response leading to eventual flare. We aimed to identify these predictive factors and develop a practical scoring system to determine the ongoing efficacy of vedolizumab.

METHODS

We performed logistic regression on prospectively recruited UC subjects from the Vedolizumab Immunomodulator Enforced Withdrawal Study (VIEWS). All patients were in corticosteroid-free clinical remission and endoscopic improvement at baseline and continued vedolizumab. Predictive factors of 2-year corticosteroid-free clinical remission were determined and modeled into the VIEWS score, then validated in a real-world UC cohort.

RESULTS

Of 62 patients in the derivation cohort, 48 (77.4%) maintained clinical remission over two years. The predictive factors of remission were female (odds ratio [OR] 6.0, 95% confidence interval [CI], 1.2-29.7), antitumor necrosis factor naive (OR 3.8, 95% CI,1.0-14.0), baseline histological remission (OR 10.8, 95% CI, 2.4-48.4), thiopurine combination (OR 3.6, 95% CI, 0.7-18.0), and fecal calprotectin level ≤250 µg/g (OR 6.3, 95% CI, 0.9-42.2). These factors were incorporated into VIEWS score, yielding an area under the receiver-operating characteristic (AUROC) curve of 0.89 (95% CI, 0.81-0.98) in the prediction of 2-year clinical remission. Of 64 UC patients in the validation cohort, 40 (62.5%) remained in clinical remission at 2 years with AUROC of 0.77 (95% CI, 0.60-0.94). At the cut-off threshold of 4, the VIEWS score identified 2-year clinical remission with a sensitivity of 88.4% and specificity of 63.6%.

CONCLUSIONS

Our study determined predictive factors and proposed a scoring system of ongoing clinical remission in UC patients on maintenance vedolizumab. In patients at high risk of relapse, combination therapy with thiopurine may be beneficial.