Efficacy and health-related quality of life associated with second-line vedolizumab after first-line treatment with one anti-TNF in patients with ulcerative colitis: a meta-analysis of the GEMINI-1 and VISIBLE-1 trials

Background: Vedolizumab is a monoclonal antibody approved for adults with moderately to severely active ulcerative colitis and an inadequate response/intolerance to conventional, or anti-tumor necrosis factor (TNF) treatment. Additional efficacy data for second-line vedolizumab after first-line anti-TNF treatment are required to determine its optimal position in the treatment sequence. Objectives: To evaluate efficacy and health-related quality of life (HRQoL) associated with second-line vedolizumab after first-line anti-TNF in patients with ulcerative colitis. Design: Meta-analysis. Data sources and methods: Data from randomized, placebo-controlled phase III trials (GEMINI-1 (NCT00783718) and VISIBLE-1 (NCT02611830)) were used. Patients who received second-line vedolizumab after first-line anti-TNF treatment within 5 years before trial enrollment were included. The primary outcome was clinical remission with two definitions based on the adapted Mayo score. Secondary outcomes were corticosteroid (CS)-free remission, Mayo endoscopic score (MES) ⩽1, and HRQoL (Inflammatory Bowel Disease Questionnaire and EuroQoL-5 Dimension Visual Analog Scale). Outcomes were assessed at Week 52. Efficacy of vedolizumab versus placebo was compared using fixed-effects models. Regression analyses assessed treatment effects, adjusting for disease location/duration and previous CS use. Results: Overall, 137 patients from GEMINI-1/VISIBLE-1 were included. Patient characteristics were similar across cohorts, although mean disease duration ranged from 6.6 to 9.9 years. Second-line vedolizumab was associated with a higher likelihood of achieving both definitions of clinical remission and all secondary outcomes (CS-free remission, MES ⩽1, and HRQoL) versus placebo. Regression analysis showed that patients treated with vedolizumab were 7.13–11.35 times more likely to achieve clinical remission (both definitions) versus placebo. Conclusion: Second-line vedolizumab after first-line anti-TNF treatment significantly increased the likelihood of achieving clinical remission, MES ⩽1, and improved HRQoL at Week 52 versus placebo in patients with ulcerative colitis. The small sample size, associated limitations, and heterogeneity observed in some outcomes warrant further research to strengthen these findings.