Efficacy and safety of biologics in relapsing polychondritis: a French national multicentre study
Efficacy and safety of biologics in relapsing polychondritis: a French national multicentre study
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DOI：
10.1136/annrheumdis-2017-212705
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发表时间：
2018-08-01
影响因子：
27.4
通讯作者：
Sailler, Laurent
中科院分区：
文献类型：
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作者：
Moulis, Guillaume;Pugnet, Gregory;Sailler, Laurent
目的评估生物制剂在复发性多囊卵巢炎（RP）患者队列中的疗效和安全性。方法我们进行了一项法国多中心回顾性队列研究，包括接受生物制剂治疗的RP患者。疗效结局为暴露前6个月内的临床缓解（部分或完全）和完全缓解，加上6个月时的每日皮质类固醇剂量。其他结果是药物不良反应（ADR），生物制剂的持久性和相关因素的respons.Results本研究包括41例患者暴露于105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）。暴露前6个月的总体缓解率为62.9%。完全缓解率为19.0%。减少皮质类固醇剂量在患者之间差异很大。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%;范围从托珠单抗的23.5%到依那西普的72.7%）、疗效丧失（18.1%）和ADR（20.9%;主要是阿那白滞素：46.7%）。生物分类之间的持久性相当。在TNF抑制剂中，阿达木单抗的持久性最高。根据生物制剂和器官受累情况，观察到临床缓解率的差异。有一个较低的反应率的情况下，与相关的骨髓增生异常综合征和较高的反应率的鼻/耳炎，胸骨炎和伴随暴露于非生物疾病修饰抗风湿drugs.Conclusions本研究描述了生物制剂的疗效难治性RP的趋势。然而，完全缓解的数量很低，人们担心ADR的风险，特别是感染。
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.