Background: Vedolizumab (VDZ) is used to treat Crohn’s disease (CD) and ulcerative colitis (UC). Data from large real-world (RW) cohorts can further characterize safety events not fully elucidated in clinical trials. Methods: We conducted a systematic review and meta-analysis of RW safety outcomes with VDZ in UC and CD. Multiple electronic databases and congress abstracts dated May 1, 2014–Jan 10, 2017 were searched for eligible studies. Reports including <10 patients (pts), pts <18 years of age or off-label VDZ use were excluded. A meta-analysis using the DerSimonian–Laird random effects method to obtain a weighted mean of adverse event (AE) rates was conducted. Results: Two hundred and eighteen published studies were identified: 35 reported safety rates on 2912 VDZ-treated pts (CD: 1571; UC: 848; unspecified/other: 33; three studies [n=460] did not report individual UC/CD data) over a mean VDZ exposure/follow-up period of 27.3 weeks (15 studies). Across studies, mean age of pts was 34–67 years, with mean disease duration of 8–16 years. Most VDZ-treated pts (62–100%) had prior exposure to ≥1 TNF antagonist therapy and 6–64% of VDZ-treated pts were receiving concomitant corticosteroids and immunomodulators. Non-infectious and infectious AEs in ≥2% of pts are shown in Table 1. Infusion-related reactions occurred in 2% (95% CI <1–4%) of pts (n=811), and malignancies were reported in <1% (<1–4%; 2 studies). The AE rate in VDZ-treated pts was 20%; 10%, 8%, and 7% for infections, serious AEs, and serious infections, respectively (Table 1). Conclusion: Meta-analysis of AE rates across multiple studies support the safety profile of VDZ seen in the GEMINI clinical trials and the favorable long-term benefit–risk profile of VDZ in RW clinical practice; with low rates of infusion-related reactions, serious infections, and malignancies, and no identification of new safety signals. Limitations of incidental reporting in RW studies include potential underestimates of AE rates.
