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预测克罗恩病患者阿达木单抗剂量升级的前瞻性队列研究。

Predictors of dose escalation of adalimumab in a prospective cohort of Crohn's disease patients.

机构信息

Department of Gastroenterology and Hepatology, Erasmus MC - University Medical Centre Rotterdam, The Netherlands.

出版信息

Aliment Pharmacol Ther. 2012 Feb;35(3):335-41. doi: 10.1111/j.1365-2036.2011.04946.x. Epub 2011 Dec 22.

Abstract

BACKGROUND

Adalimumab is effective for the induction and maintenance of remission in Crohn's disease (CD)-patients.

AIM

To find predictors for adalimumab dose escalation at initiation of adalimumab.

METHODS

Crohn's disease patients in a single tertiary referral centre who started adalimumab between July 2007 and March 2010 at an induction dose (week 0 160 mg subcutaneously (sc), week 2 80 mg sc) and maintenance dose of 40 mg sc thereafter every other week were followed prospectively. Patients on adalimumab for at least 3 months were included. The number of patients needing dose escalation was assessed. Patients that needed dose escalation were compared with patients that did not need dose escalation.

RESULTS

Of 199 CD patients treated with adalimumab and followed prospectively, 122 patients (M/F 54/68, median age 35 years, range 18-66 years, median CDAI 164, range 6-468) were treated for 3 months. In total 38% of these patients (46/122) needed a dose escalation within a median time of 21 weeks after adalimumab introduction (range 4-105). Body mass index (BMI) (P < 0.03) and secondary non-response to infliximab (IFX) (P < 0.06) were identified as predictors for dose escalation. Concomitant use of immunomodulators at initiation of adalimumab and the presence of autoantibodies to IFX did not predict dose escalation.

CONCLUSIONS

Over one-third adalimumab-treated patients are dose escalated within a median of 5 months. Higher BMI and secondary non-response to IFX treatment are predictive for a dose escalation during adalimumab treatment.

摘要

背景

阿达木单抗对于诱导和维持克罗恩病(CD)患者的缓解有效。

目的

寻找阿达木单抗起始治疗时需要增加剂量的预测因子。

方法

在单中心回顾性研究中,纳入 2007 年 7 月至 2010 年 3 月期间起始剂量为 160mg 皮下注射(sc),第 2 周 80mg sc,此后每 2 周 40mg sc 维持剂量的 CD 患者。至少接受 3 个月阿达木单抗治疗的患者纳入研究。评估需要增加剂量的患者数量。比较需要增加剂量的患者和不需要增加剂量的患者。

结果

199 例接受阿达木单抗治疗并进行前瞻性随访的 CD 患者中,122 例(M/F 54/68,中位年龄 35 岁,范围 18-66 岁,中位 CDAI 164,范围 6-468)接受治疗 3 个月。这些患者中有 38%(46/122)在阿达木单抗治疗后中位时间 21 周内(范围 4-105)需要增加剂量。体重指数(BMI)(P < 0.03)和对英夫利昔单抗(IFX)的继发无应答(P < 0.06)被确定为需要增加剂量的预测因子。阿达木单抗起始时同时使用免疫调节剂和存在抗 IFX 自身抗体并不能预测剂量增加。

结论

三分之一以上接受阿达木单抗治疗的患者在中位时间 5 个月内需要增加剂量。较高的 BMI 和对 IFX 治疗的继发无应答是阿达木单抗治疗期间需要增加剂量的预测因子。

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