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阿达木单抗治疗既往未接受其他抗 TNF 治疗的儿童克罗恩病患者的长期疗效。

Long-term efficacy of adalimumab in paediatric Crohn's disease patients naïve to other anti-TNF therapies.

机构信息

Pediatric Inflammatory Bowel Disease Unit, Department of Paediatric Gastroenterology, Hepatology and Nutrition, Hospital Sant Joan de Déu, Barcelona, Spain.

出版信息

J Crohns Colitis. 2010 Nov;4(5):594-8. doi: 10.1016/j.crohns.2010.04.002. Epub 2010 May 1.

Abstract

INTRODUCTION

Adalimumab is a fully-humanized anti-TNF a antibody that has showed its efficacy in Crohn's disease (CD) adult patients. Its less immunogenic composition seems to be an advantage compared to previous anti-TNF α, mainly infliximab. Good response to adalimumab has been reported in patients naïve to infliximab, in those in whom infliximab has shown no efficacy and in those intolerant or who have lost previous response to it. Adalimumab has shown also its efficacy as a second-line anti-TNF α in small series of paediatric CD but data regarding its use in children naïve to infliximab are scarce.

AIM

To report our experience with adalimumab as first line anti-TNF α treatment in paediatric CD.

PATIENTS AND METHODS

Four CD paediatric patients (2 boys) previously naïve to infliximab have received adalimumab. Mean age at diagnosis: 13 years, 4 months. Adalimumab was initiated in our patients soon after diagnosis (mean time from diagnosis: 8.5 months, range: 1 month 15 days-14 months) at decreasing loading doses (160 mg and 80 mg two weeks after) and then 40 mg subsequently every two weeks.

RESULTS

The four patients entered in remission after the first dose of adalimumab (mean previous PCDAI: 35, mean PCDAI after first dose: 3.6). No adverse effects were registered. Azathioprine was stopped after 4 months of combination therapy, without loss of efficacy or adverse reactions attributable to immunogenicity. All the 4 patients have remained in remission on adalimumab monotherapy for a mean follow-up of 17 months (range 9-20 months).

CONCLUSION

Adalimumab has shown its efficacy in our paediatric CD patients naïve to other anti-TNF α drugs. Early introduction of anti-TNF α antibodies in these patients could help to a better control of the disease. Its less immunogenicity and the possibility of a home-based administration are advantages when compared to other parenteral anti-TNF treatments. Change to monotherapy after prior successful combination therapy with azathioprine and adalimumab is a safe strategy that can help to minimize possible risks of intensive immunomodulation.

摘要

简介

阿达木单抗是一种全人源抗 TNF-α 单克隆抗体,已显示其在克罗恩病(CD)成年患者中的疗效。与之前的抗 TNF-α 药物(主要是英夫利昔单抗)相比,其免疫原性较低的组成似乎是一个优势。在从未接受过英夫利昔单抗治疗、英夫利昔单抗治疗无效或不能耐受或之前对其失去反应的患者中,阿达木单抗治疗均有良好的反应。阿达木单抗在小系列儿科 CD 患者中也显示出作为二线抗 TNF-α 的疗效,但关于其在从未接受过英夫利昔单抗治疗的儿童中的使用的数据很少。

目的

报告我们在儿科 CD 中使用阿达木单抗作为一线抗 TNF-α 治疗的经验。

患者和方法

4 名 CD 儿科患者(2 名男性)之前未接受过英夫利昔单抗治疗,接受了阿达木单抗治疗。诊断时的平均年龄:13 岁 4 个月。我们的患者在诊断后不久(诊断后平均时间:8.5 个月,范围:1 个月 15 天-14 个月)开始接受阿达木单抗治疗,采用逐渐减少的负荷剂量(2 周后分别为 160mg 和 80mg),然后每 2 周随后给予 40mg。

结果

4 名患者在接受第一剂阿达木单抗后进入缓解期(平均先前 PCDAI:35,第一剂后平均 PCDAI:3.6)。未出现不良反应。在联合治疗 4 个月后停用了硫唑嘌呤,无因免疫原性而导致的疗效丧失或不良反应。4 名患者在阿达木单抗单药治疗中均保持缓解,平均随访 17 个月(9-20 个月)。

结论

阿达木单抗在我们之前未接受过其他抗 TNF-α 药物的儿科 CD 患者中显示出疗效。在这些患者中尽早引入抗 TNF-α 抗体有助于更好地控制疾病。与其他肠外抗 TNF 治疗相比,其免疫原性较低且可进行家庭管理是其优势。在先前成功联合使用硫唑嘌呤和阿达木单抗治疗后改为单药治疗是一种安全策略,可帮助最大程度降低强化免疫调节的潜在风险。

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