Department of Pharmacy, First Hospital of Jilin University, Changchun, China.
Department of Pediatric Gastroenterology Unit, First Hospital of Jilin University, Changchun, China.
BMC Pediatr. 2022 Apr 4;22(1):175. doi: 10.1186/s12887-022-03229-x.
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).
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 December 3 2021.
Ten studies, comprising 455 patients were included. For CD, the pooled clinical remission rates were 25% (19/75) at 6 weeks, 28% (25/85) at 14 weeks, 32% (17/53) at 22 weeks, and 46% (43/92) at 1 year. For UC/IBD-U, the pooled clinical remission rates were 36% (25/70) at 6 weeks, 48% (52/101) at 14 weeks, 53% (24/45) at 22 weeks, and 45% (50/112) 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.
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, and about half of patients achieved remission at 1 year with reasonable safety profile. Long-term benefit profile data and high quality evidence are still needed.
在儿科中使用维得利珠单抗仍然是超适应证的，而且相关数据有限。我们进行了一项系统评价，评估了维得利珠单抗治疗炎症性肠病（IBD）儿童和青少年的疗效和安全性。
系统检索了 PubMed、EMBASE 和 Cochrane 数据库中关于维得利珠单抗治疗 IBD 儿童和青少年的研究，这些研究报告了临床缓解、应答、无皮质类固醇缓解、黏膜愈合或安全性，检索时间截至 2021 年 12 月 3 日。
纳入了 10 项研究，共 455 例患者。对于 CD，6 周时的临床缓解率为 25%（19/75），14 周时为 28%（25/85），22 周时为 32%（17/53），1 年时为 46%（43/92）。对于 UC/IBD-U，6 周时的临床缓解率为 36%（25/70），14 周时为 48%（52/101），22 周时为 53%（24/45），1 年时为 45%（50/112）。黏膜愈合分别见于 17%-39%的 CD 和 15%-34%的 UC/IBD-U。6%的患者报告了严重不良事件。
基于病例系列的低质量证据表明，大约三分之一和一半的 CD 和 UC/IBD-U 患者分别在 22 周内达到缓解，大约一半的患者在 1 年内达到缓解，且安全性良好。仍需要长期获益数据和高质量证据。
