mepolizumab治疗日本嗜酸性肉芽肿合并多血管炎患者的安全性和有效性:MARS研究的亚组分析

IF 1.9 4区 医学 Q3 RHEUMATOLOGY
Tomonori Ishii, Hideaki Kunishige, Mitsuhiro Yoshida, Etsuko Hayashi, Masaki Komatsubara, Rafael Alfonso-Cristancho, Peter Howarth
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引用次数: 0

摘要

目的评估mepolizumab在嗜酸性肉芽肿病合并多血管炎患者亚组中的长期安全性和有效性,包括:疾病持续时间、口服皮质类固醇的使用、复发、加重或新发症状、抗中性粒细胞细胞质抗体状态和免疫抑制治疗的使用。方法在日本进行为期96周的MARS研究,对接受mepolizumab治疗≥96周的患者进行数据分析,重点关注不良事件、临床症状、平均每日口服皮质类固醇剂量和复发。结果肾上腺皮质激素暴露在大多数亚组中减少,特别是在抗中性粒细胞细胞质抗体阴性亚组中。在观察期间,平均口服皮质类固醇剂量较高的患者(>7.5 mg/天vs≤7.5 mg/天)经历了更多的不良事件,包括感染相关不良事件和临床症状,以及更高的复发率。在平均剂量为0.0 mg/天口服皮质类固醇的患者中未观察到复发。减少口服皮质类固醇的使用与改善临床结果相关,特别是在无复发的患者中。结论mepolizumab与嗜酸性肉芽肿合并多血管炎病程、抗中性粒细胞细胞质抗体状态或免疫抑制剂使用无关。与低剂量相比,较高的口服皮质类固醇剂量与更多的不良事件、临床症状和复发有关。在无复发患者中,继续使用美波珠单抗可减少不良事件,降低口服皮质类固醇剂量,并改善症状。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-world safety and effectiveness of mepolizumab for patients with eosinophilic granulomatosis with polyangiitis in Japan: a subgroup analysis of the MARS study.

ObjectivesEvaluate the long-term safety and effectiveness of mepolizumab in subgroups of patients with eosinophilic granulomatosis with polyangiitis, including: disease duration, oral corticosteroid use, relapse, worsening or new-onset symptoms, anti-neutrophil cytoplasm antibodies status, and immunosuppressive therapy use. MethodsData from the 96-week MARS study in Japan were analysed for patients receiving mepolizumab for ≥96 weeks, focusing on adverse events, clinical symptoms, average daily oral corticosteroid dose, and relapse. ResultsOral corticosteroid exposure decreased in most subgroups, particularly in the anti-neutrophil cytoplasm antibodies negative subgroup. Patients on higher average oral corticosteroid doses (>7.5 mg/day versus ≤ 7.5 mg/day, during the observation period) experienced more adverse events, including infection-related adverse events and clinical symptoms, and higher relapse rates. No relapses were observed in patients on an average dose of 0.0 mg/day oral corticosteroids. Reduced oral corticosteroid use was associated with improved clinical outcomes, particularly in patients who remained relapse-free. ConclusionMepolizumab was effective regardless of eosinophilic granulomatosis with polyangiitis duration, anti-neutrophil cytoplasm antibodies status, or immunosuppressant use. Higher oral corticosteroid doses were linked to more adverse events, clinical symptoms, and relapses compared to lower doses. In relapse-free patients, continued mepolizumab use led to fewer adverse events, lower oral corticosteroid doses, and improved symptoms.

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来源期刊
Modern Rheumatology
Modern Rheumatology RHEUMATOLOGY-
CiteScore
4.90
自引率
9.10%
发文量
146
审稿时长
1.5 months
期刊介绍: Modern Rheumatology publishes original papers in English on research pertinent to rheumatology and associated areas such as pathology, physiology, clinical immunology, microbiology, biochemistry, experimental animal models, pharmacology, and orthopedic surgery. Occasional reviews of topics which may be of wide interest to the readership will be accepted. In addition, concise papers of special scientific importance that represent definitive and original studies will be considered. Modern Rheumatology is currently indexed in Science Citation Index Expanded (SciSearch), Journal Citation Reports/Science Edition, PubMed/Medline, SCOPUS, EMBASE, Chemical Abstracts Service (CAS), Google Scholar, EBSCO, CSA, Academic OneFile, Current Abstracts, Elsevier Biobase, Gale, Health Reference Center Academic, OCLC, SCImago, Summon by Serial Solutions
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