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生物制剂治疗复发性多软骨炎的疗效和安全性:一项法国全国多中心研究。

Efficacy and safety of biologics in relapsing polychondritis: a French national multicentre study.

机构信息

UMR 1027, INSERM, University of Toulouse, Toulouse, France.

Department of Internal Medicine, Toulouse University Hospital, Toulouse, France.

出版信息

Ann Rheum Dis. 2018 Aug;77(8):1172-1178. doi: 10.1136/annrheumdis-2017-212705. Epub 2018 Mar 13.

DOI:10.1136/annrheumdis-2017-212705
PMID:29535124
Abstract

OBJECTIVES

To assess the efficacy and the safety of biologics in a cohort of patients with relapsing polychondritis (RP).

METHODS

We conducted a French multicentre retrospective cohort study including patients treated with biologics for RP. Efficacy outcomes were clinical response (partial or complete) and complete response during the first 6 months of exposure, plus daily corticosteroid dose at 6 months. Other outcomes were adverse drug reactions (ADRs), persistence of biologics and factors associated with a response.

RESULTS

This study included 41 patients exposed to 105 biologics (tumour-necrosis factor (TNF) inhibitors, n=60; tocilizumab, n=17; anakinra, n=15; rituximab, n=7; abatacept, n=6). Overall response rate during the first 6 months of exposure was 62.9%. Complete response rate was 19.0%. Reduced corticosteroid doses were highly variable among patients. ADRs were mostly infections (n=42). Reasons for biologic withdrawal (73.3%) were insufficient efficacy (34.3%; ranging from 23.5% for tocilizumab to 72.7% for etanercept), loss of efficacy (18.1%) and ADRs (20.9%; mostly for anakinra: 46.7%). Persistence was comparable among biologic classes. Among TNF inhibitors, the highest persistence was observed with adalimumab. Differences in clinical response rates were observed depending on biologics and organ involvement. There were trends towards a lower response rate in cases with associated myelodysplastic syndrome and for a higher response rate for nasal/auricular chondritis, sternal chondritis and concomitant exposure to non-biologic disease-modifying antirheumatic drugs.

CONCLUSIONS

This study describes the efficacy of biologics for refractory RP. However, the number of complete responses was low and there were concerns about the risk of ADRs, particularly infections.

摘要

目的

评估生物制剂在复发性多软骨炎(RP)患者中的疗效和安全性。

方法

我们进行了一项法国多中心回顾性队列研究,纳入了接受生物制剂治疗 RP 的患者。疗效结局包括临床缓解(部分或完全)和暴露后 6 个月内的完全缓解,以及 6 个月时的每日皮质类固醇剂量。其他结局包括药物不良反应(ADR)、生物制剂的持续时间以及与缓解相关的因素。

结果

本研究纳入了 41 名接受 105 种生物制剂(肿瘤坏死因子(TNF)抑制剂,n=60;托珠单抗,n=17;阿那白滞素,n=15;利妥昔单抗,n=7;阿巴西普,n=6)治疗的患者。暴露后 6 个月内的总体缓解率为 62.9%。完全缓解率为 19.0%。患者的皮质类固醇剂量降低幅度差异较大。ADR 主要为感染(n=42)。生物制剂停药的原因(73.3%)为疗效不足(34.3%;托珠单抗为 23.5%,依那西普为 72.7%)、疗效丧失(18.1%)和 ADR(20.9%;主要为阿那白滞素:46.7%)。不同生物制剂类别之间的药物持续时间无差异。TNF 抑制剂中,阿达木单抗的持续时间最长。不同生物制剂和器官受累的临床缓解率存在差异。伴有骨髓增生异常综合征的患者缓解率较低,而鼻/耳软骨炎、胸骨软骨炎和同时接受非生物性疾病修饰抗风湿药物治疗的患者缓解率较高。

结论

本研究描述了生物制剂治疗难治性 RP 的疗效。然而,完全缓解率较低,且存在对 ADR(尤其是感染)风险的担忧。

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