维得利珠单抗治疗原发性生物制剂治疗失败的儿童炎症性肠病患者安全有效。
Vedolizumab Is Safe and Efficacious for the Treatment of Pediatric-Onset Inflammatory Bowel Disease Patients Who Fail a Primary Biologic Agent.
机构信息
Department of Pediatrics, School of Medicine, Kyungpook National University, Daegu, Korea.
Department of Pediatrics, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
出版信息
J Korean Med Sci. 2022 Sep 26;37(37):e282. doi: 10.3346/jkms.2022.37.e282.
BACKGROUND
Vedolizumab (VDZ) is currently licensed for use in adults for the treatment of inflammatory bowel disease (IBD). We aimed to investigate the clinical course of pediatric-onset IBD following treatment with VDZ as more than a secondary biologic agent. We also evaluated factors associated with secondary loss of response (LOR) and durability of VDZ treatment.
METHODS
Pediatric-onset IBD patients diagnosed at an age younger than 18 years who had received VDZ as more than a secondary biologic agent were included in this retrospective observational study conducted at the Department of Pediatrics of two centers in Korea. Comparative analysis was conducted between groups divided according to the development of secondary LOR during VDZ treatment.
RESULTS
A total of 24 patients comprising 10 patients with Crohn's disease and 14 with ulcerative colitis were included. Of these, 19 were male and 5 were female. The mean age at diagnosis was 14.6 ± 2.5 years. The mean age at initiation of VDZ was 20.5 ± 2.8 years. Nine patients (37.5%) had received two or more biologic agents before starting VDZ. During a median of 0.9 years follow-up from VDZ initiation, 9 patients (37.5%) experienced LOR requiring interval shortening and 4 patients (16.7%) were changed to a different biologic agent. According to multivariate Cox proportional hazard regression analysis, administration of two or more biologic agents before VDZ treatment was the only factor positively associated with LOR (hazard ratio [HR], 5.6; 95% confidence interval [CI], 1.026-30.56; = 0.047), while LOR was the only factor negatively associated with VDZ durability (HR, 0.003; 95% CI, 0.00-0.08; = 0.010). No adverse events were observed during treatment with VDZ.
CONCLUSION
VDZ is safe and efficacious for the treatment of pediatric-onset IBD patients failing a primary biologic agent. The durability of VDZ may be enhanced by introducing VDZ earlier in the disease course. Further prospective studies in children are required in the future to validate these findings.
背景
维得利珠单抗（VDZ）目前被批准用于治疗成人炎症性肠病（IBD）。我们旨在研究儿科发病的 IBD 患者在接受 VDZ 治疗后，作为二线生物制剂以上的药物的临床过程。我们还评估了与继发性无应答（LOR）和 VDZ 治疗持久性相关的因素。
方法
本回顾性观察研究在韩国的两个中心的儿科部门进行，纳入了诊断年龄小于 18 岁的儿科发病 IBD 患者，他们接受了 VDZ 作为二线生物制剂以上的药物。对接受 VDZ 治疗期间发生继发性 LOR 的患者进行了分组比较分析。
结果
共有 24 例患者纳入研究，包括 10 例克罗恩病患者和 14 例溃疡性结肠炎患者。其中 19 例为男性，5 例为女性。诊断时的平均年龄为 14.6±2.5 岁。开始 VDZ 治疗的平均年龄为 20.5±2.8 岁。9 例（37.5%）患者在开始 VDZ 治疗前已接受两种或更多种生物制剂。在 VDZ 治疗开始后的中位 0.9 年随访期间，9 例（37.5%）患者出现 LOR，需要缩短间隔，4 例（16.7%）患者换用了另一种生物制剂。根据多变量 Cox 比例风险回归分析，在开始 VDZ 治疗前使用两种或更多种生物制剂是 LOR 的唯一阳性相关因素（危险比[HR]，5.6；95%置信区间[CI]，1.026-30.56；=0.047），而 LOR 是与 VDZ 耐久性唯一负相关的因素（HR，0.003；95%CI，0.00-0.08；=0.010）。在 VDZ 治疗期间未观察到不良反应。
结论
VDZ 治疗原发性生物制剂治疗失败的儿科发病 IBD 患者是安全有效的。通过更早地在疾病过程中引入 VDZ，可能会提高 VDZ 的耐久性。未来需要在儿童中进行进一步的前瞻性研究来验证这些发现。
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