Relationship between lymphocyte count and risk of infection in Japanese rheumatoid arthritis patients treated with tofacitinib.

IF 1.8 4区 医学 Q3 RHEUMATOLOGY
Yoshiya Tanaka, Tsutomu Takeuchi, Hernan Valdez, Mark Collinge, Samuel H Zwillich, Shigeyuki Toyoizumi, Kenneth Kwok, Tomohiro Hirose
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Abstract

Objectives: We characterised changes in absolute lymphocyte counts (ALCs) and lymphocyte subset counts (LSCs), and their relationship to incidence of serious infection events (SIEs) and herpes zoster (HZ) events in Japanese patients with moderate to severe rheumatoid arthritis enrolled in the tofacitinib clinical programme.

Methods: Data included 765 patients receiving tofacitinib in Phase 2, Phase 3, and long-term extension studies. ALCs/LSCs and incidence rates (patients with events/100 patient-years) of SIEs and HZ were analysed over 75 months.

Results: Median ALCs were generally stable over 75 months of treatment. Transient numerical increases from baseline in median LSCs were observed at Month 3; LSCs were generally lower than baseline for Months 36-75. SIE/HZ incidence rates were higher in patients with ALC <0.5 × 103 cells/mm3 versus those with ALC ≥0.5 × 103 cells/mm3 during tofacitinib treatment. Baseline LSCs were similar in patients with/without SIEs or HZ events.

Conclusions: SIE/HZ risk was highest in patients with ALC <0.5 × 103 cells/mm3, supporting this threshold as clinically relevant for defining increased SIE/HZ risk in Japanese patients with rheumatoid arthritis receiving tofacitinib. However, SIEs and HZ events did not necessarily occur simultaneously with confirmed lymphopenia, preventing conclusions on possible causal relationships being drawn.

接受托法替尼治疗的日本类风湿性关节炎患者的淋巴细胞计数与感染风险之间的关系。
研究目的我们研究了参加托法替尼临床项目的日本中重度类风湿关节炎患者的绝对淋巴细胞计数(ALCs)和淋巴细胞亚群计数(LSCs)的变化及其与严重感染事件(SIEs)和带状疱疹事件(HZ)发生率的关系:数据包括在2期、3期和长期扩展研究中接受托法替尼治疗的765名患者。对75个月内的ALCs/LSCs以及SIEs和HZ的发生率(发生事件的患者/100患者年)进行了分析:结果:在75个月的治疗过程中,ALC中位数基本保持稳定。在第 3 个月,观察到中位 LSCs 从基线开始出现短暂的数值增加;在第 36-75 个月,LSCs 一般低于基线。ALC患者的SIE/HZ发病率较高 结论:ALC患者的SIE/HZ发病率较高:ALC患者的SIE/HZ风险最高
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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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