Systematic review with meta-analysis: real-world effectiveness and safety of vedolizumab in patients with inflammatory bowel disease

Abstract

BackgroundSelective patient recruitment can produce discrepancies between clinical trial results and real-world effectiveness.MethodsA systematic literature review and meta-analysis were conducted to assess vedolizumab real-world effectiveness and safety in patients with ulcerative colitis (UC) or Crohn’s disease (CD). MEDLINE, MEDLINE In-Process, EMBASE, and Cochrane databases were searched for real-world studies of vedolizumab in adult patients with UC/CD reporting clinical response, remission, corticosteroid-free remission, UC/CD-related surgery or hospitalization, mucosal healing, or safety published from May 1, 2014–June 22, 2017. Response and remission rates were combined in random-effects meta-analyses.ResultsAt treatment week 14, 32% of UC patients [95% confidence interval (CI) 27–39%] and 30% of CD patients (95% CI 25–34%) were in remission; and at month 12, 46% for UC (95% CI 37–56%) and 30% for CD (95% CI 20–42%). For UC, the rates of corticosteroid-free remission were 26% at week 14 (95% CI 20–34%) and 42% at month 12 (95% CI 31–53%); for CD they were 25% at week 14 (95%, CI 20–31%) and 31% at month 12 (95%, CI 20–45%). At month 12, 33–77% of UC and 6–63% of CD patients had mucosal healing. Nine percent of patients reported serious adverse events.ConclusionsVedolizumab demonstrated real-world effectiveness in patients with moderate-to-severely active UC or CD, with approximately one-half and one-third of patients, respectively, in remission at treatment month 12. These findings are consistent with clinical trial data and support the long-term benefit–risk profile of vedolizumab.Electronic supplementary materialThe online version of this article (10.1007/s00535-018-1480-0) contains supplementary material, which is available to authorized users.

Vedolizumab for Inflammatory Bowel Disease: Two‐Year Results of the Initiative on Crohn and Colitis (ICC) Registry, A Nationwide Prospective Observational Cohort Study

“…The safety profile of vedolizumab therapy observed in our study was similar to earlier studies (GEMINI trials and real‐world cohorts) . The incidence of serious adverse events and severe infections was relatively low with 2.9 and 3.7 per 100 patient years, respectively.…”

A clinical decision support tool may help to optimise vedolizumab therapy in Crohn’s disease

“…1 Similar results were recently reported in a meta-analysis of observational studies with an estimated 1 year corticosteroid-free remission rate of 31% (95% confidence interval [CI] 20-45%). 2,3 These data underscore that while a substantial proportion of treatment-resistant patients respond to VDZ therapy, the majority do not. Although this circumstance is likely multifactorial, variability in VDZ pharmacokinetics (PK) is a potential explanation in some patients.…”

“…In the GEMINI 2 pivotal phase 3 clinical trial of vedolizumab (VDZ) for Crohn’s disease (CD), approximately one‐third of patients with active CD achieved corticosteroid‐free remission at week 52 . Similar results were recently reported in a meta‐analysis of observational studies with an estimated 1 year corticosteroid‐free remission rate of 31% (95% confidence interval [CI] 20‐45%) . These data underscore that while a substantial proportion of treatment‐resistant patients respond to VDZ therapy, the majority do not.…”

Effects of vedolizumab in Japanese patients with Crohn’s disease: a prospective, multicenter, randomized, placebo-controlled Phase 3 trial with exploratory analyses

“…The GEMINI LTS study also revealed long-term maintenance of vedolizumab efficacy regardless of prior anti-TNFa exposure [26]. In patients who achieved remission induction after administration of vedolizumab, maintenance of remission may be improved based on the lower immunogenicity of vedolizumab [27].…”