P727 Effectiveness and Safety of Vedolizumab in Inflammatory Bowel Disease: A Comprehensive Meta-analysis of Observational Studies
Macaluso, F.S.(1)*;Ventimiglia, M.(2);Orlando, A.(3);
(1)"Villa Sofia-Cervello” Hospital, IBD Unit, Palermo, Italy;(2)Italian Ministry of Health, Directorate General of Medical Device and Pharmaceutical Service- Italian Ministry of Health, Rome, Italy;(3)“Villa Sofia-Cervello” Hospital, IBD Unit, Palermo, Italy;
Background
Many observational studies on the use of vedolizumab (VDZ) in patients with Crohn’s disease (CD) and ulcerative colitis (UC) have been published in the last few years. We aimed to comprehensively summarize its effectiveness and safety by pooling data only from observational studies.
Methods
PubMed/Medline and Embase were systematically searched for observational studies on patients with CD and UC treated with VDZ through December 2021. The rates of clinical remission and overall adverse events were the primary outcomes. The rates of steroid-free clinical remission, clinical response, mucosal healing, C-reactive protein normalization, loss of response, colectomy, serious adverse events, infections, and malignancies were considered as secondary outcomes.
Results
Eighty-eight studies comprising 25,678 patients (13,663 with CD and 12,015 with UC) met the inclusion criteria. In patients with CD, the pooled estimate rates of clinical remission were 36% at induction and 39% at maintenance. In patients with UC, the pooled estimate rates of clinical remission were 40% at induction and 45% at maintenance. The pooled estimate of incidence rate of adverse events was 34.6 per 100 person-years. At multivariable meta-regression analysis, studies with increased male proportion were independently associated with higher rates of clinical remission and steroid-free clinical remission at both induction and maintenance, and clinical response at maintenance in patients with CD. Studies with increased disease duration were independently associated with higher mucosal healing rates at maintenance in patients with UC.
Conclusion
Observational studies demonstrated extensively the effectiveness of VDZ, with a reassuring safety profile.