Efficacy and Safety of Vedolizumab for Pediatrics With Inflammatory Bowel Disease: a Systematic Review

Abstract

Background: Vedolizumab use in pediatrics is still off-label and the data are limited. We conducted a systematic review evaluating the efficacy and safety of vedolizumab in children and adolescents with inflammatory bowel disease (IBD). Methods: PubMed, EMBASE and Cochrane databases were systematically searched for studies of vedolizumab in children and adolescents with IBD reporting clinical remission, response, corticosteroid-free (CS-free) remission, mucosal healing, or safety up to November 21 2020. Results: 7 studies, comprising 238 patients were included. For CD, the pooled clinical remission rates were 25% (19/75) at 6 weeks, 28% (19/67) at 14 weeks, 32% (17/53) at 22 weeks, and 25% (1/4) at 1 year. For UC/IBD-U, the pooled clinical remission rates were 36% (25/70) at 6 weeks, 52% (32/61) at 14 weeks, 53% (24/45) at 22 weeks, and 60% (6/10) at 1 year. Mucosal healing was found in 17%-39% of CD and 15%-34% of UC/IBD-U respectively. Six percent of patients reported serious adverse events.Conclusions: According to low-quality evidence based on case series, approximately one-third and one-half of patients for CD and UC/IBD-U respectively achieved remission within 22 weeks. Long-term benefit profile data and high quality evidence are still needed.

Effectiveness and safety of biologics in pediatric inflammatory bowel disease: Real-life data from the Sicilian Network

“…With loss of treatment response estimated as 13% per patient year of IFX therapy [36], children, who inherently have longer treatment duration than patients with adult-onset disease, are at greatest risk for losing biological treatment options, especially when those options are already limited to anti-TNF agents. In the search to enlarge the therapeutic armamentarium, newer biologics, namely vedolizumab (Entyvio, Takeda), ustekinumab (Stelara, Janssen), golimumab (Simponi, Janssen) are off-label used as second-line biologic agents with evidence limited to case reports or small trials in pediatric populations [5,38,39,40].…”