Efficacy and safety of vedolizumab for inflammatory bowel diseases: A systematic review and meta-analysis of randomized controlled trials

Abstract

Background: Vedolizumab is a humanized monoclonal antibody that inhibits gut-selective α4β7 integrins on the surface of leukocytes, preventing their trafficking into the gastrointestinal tract, and ultimately achieves the effect of suppressing intestinal inflammation. This study aimed to evaluate the efficacy and safety of vedolizumab in the treatment of inflammatory bowel disease.Methods: After a systematic review of relevant studies, the pooled relative risk (RR) and 95% confidence intervals (CIs) were calculated to evaluate the effect. Heterogeneity was explored using sensitivity analysis, univariate meta-regression, and subgroup analysis. Potential publication bias was evaluated using Egger test and trim-and-fill method.Results: Nine randomized controlled trials involving 4268 participants were included in the meta-analysis. During induction therapy, vedolizumab was more effective than placebo in treating active ulcerative colitis and Crohn disease in terms of clinical response (RR = 1.55, 95%CI: 1.35-1.78), clinical remission (RR = 1.90, 95%CI: 1.50-2.41), and mucosal healing (RR = 1.53, 95%CI: 1.21-1.95). A superior effect in terms of durable Clinical or Crohn disease Activity Index-100 response (RR = 1.65, 95%CI: 1.20-2.26), clinical remission (RR = 1.92, 95%CI: 1.48-2.50), and glucocorticoid-free remission (RR = 2.22, 95%CI: 1.71-2.90) was found during maintenance treatment. Vedolizumab was not associated with any adverse events and was as safe as placebo in terms of the risk of serious adverse reactions.Conclusions: Vedolizumab may be safe and effective as an induction and maintenance therapy for the treatment of inflammatory bowel disease; however, further studies are needed to validate this conclusion.

Ulcerative Colitis in Adults

“…Treatment goals include inducing clinical remission (ie, induction) and preventing future flares of disease activity (ie, maintenance) . The Table describes the classes of medications used for induction and/or maintenance of UC including dose and administration, efficacy data, and safety considerations. Drugs in different classes have been developed because a number of patients do not respond to drugs and/or lose response over time.…”

“…Vedolizumab adverse events compared with placebo (9 RCTs of UC and Crohn disease (N = 4268): RR, 1.01 (95% CI, 0.96-1.07) …”

“…Vedolizumab is a gut-selective monoclonal antibody against the integrin α4β7 (Figure 1). The lack of systemic immunosuppression results in a favorable safety profile . Efficacy was demonstrated in the GEMINI I trial (N = 374 in the induction study and N = 521 in the maintenance study) with week 6 clinical response of 47.1% vs 35.5% with placebo ( P < .001) and at week 52 of 41.8% vs 15.9% with placebo ( P < .001) …”

Anti-TNF Agents and New Biological Agents (Vedolizumab and Ustekinumab) in the Prevention and Treatment of Postoperative Recurrence After Surgery in Crohn’s Disease

“…Vedolizumab is a selective humanised immunoglobulin G1 monoclonal antibody to α4β7 integrin that blocks lymphocyte trafficking to gut mucosa [ 161 , 162 ]. Both RCTs and observational studies have shown the efficacy of vedolizumab to induce clinical and endoscopic remission in patients who were naïve to, and who previously failed anti-TNF agents [ 163 , 164 ]. Vedolizumab is increasingly used as postoperative prophylactic treatment for CD patients, especially in those at high risk for POR [ 63 ].…”

Terapia Biológica y Moduladores del Sistema Inmunológico en el tratamiento de las Enfermedades Inflamatorias Intestinales

“…Inducción y mantenimiento de la respuesta y remisión: Vedolizumab mostró efectividad en términos de respuesta clínica, remisión clínica y curación de la mucosa en la colitis ulcerosa y la enfermedad de Crohn (38).…”