托法替尼在日本类风湿关节炎患者的三年安全性和有效性:一项全病例上市后监测研究的最终分析

IF 1.9 4区 医学 Q3 RHEUMATOLOGY
Masataka Kuwana, Naonobu Sugiyama, Shigeki Momohara, Tatsuya Atsumi, Syuji Takei, Naoto Tamura, Masayoshi Harigai, Takao Fujii, Hiroaki Matsuno, Kazuhiko Yamamoto, Yoshinari Takasaki, Nami Okamoto, Nobunori Takahashi, Atsuo Nakajima, Ayako Nakajima, Miki Tanigawa, Yutaka Endo, Toshitaka Hirano, Masato Hoshi, Tsuneyo Mimori, Michiaki Takagi, Sakae Tanaka, Yoshiya Tanaka, Tsutomu Takeuchi
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引用次数: 0

摘要

目的:在一项为期3年的全病例上市后监测研究中,评估tofacitinib在日本类风湿性关节炎患者中的实际安全性/有效性。方法:在日本注册所有开始使用tofacitinib的类风湿关节炎患者(2013年7月30日- 2017年12月3日)。比较活动性类风湿关节炎患者在接受托法替尼或其他药物(对照组:甲氨蝶呤/其他疾病改善抗风湿药物/免疫抑制剂)治疗后,每周服用8mg甲氨蝶呤≥3个月的严重感染/恶性肿瘤/死亡率。在3年内评估疾病活动性。结果:粘附性比较安全性分析集包括3731/2419例(托法替尼/对照)患者。基线(托法替尼/对照)生物疾病改善抗风湿药物史(53.3%/12.2%)、甲氨蝶呤史(81.4%/98.6%)和类风湿关节炎分期(I-II: 45.3%/67.1%)和类别(1-2:76.5%/90.8%)在组间差异较大。对于托法替尼与对照组,严重感染的发生率(事件患者/100患者-年[95%置信区间])为6.86 (5.96-7.86)vs 1.42(0.97-2.00)(校正风险比3.25-3.80);恶性肿瘤为1.40 (1.18-1.66)vs 0.88(0.66-1.15)(校正风险比1.37-1.53);死亡率为0.89 (0.72-1.10)vs 0.26(0.15-0.43)(未调整的风险比为3.29)。托法替尼的缓解/低疾病活动率在3年内增加。结论:与对照组相比,托法替尼组的严重感染率更高,恶性肿瘤发生率更高。由于不平衡组和未测量的混杂因素,结果应谨慎解释。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Three-year safety and effectiveness of tofacitinib in patients with rheumatoid arthritis in Japan: Final analysis of an all-case postmarketing surveillance study.

Objective: To evaluate tofacitinib real-world safety/effectiveness in patients with rheumatoid arthritis (RA) in Japan in a 3-year all-case postmarketing surveillance study.

Methods: All patients with RA who initiated tofacitinib (30 July 2013-03 December 2017) were registered in Japan. Serious infections/malignancy/mortality incidences were compared in patients with active RA after >8 mg methotrexate/week for ≥3 months who received tofacitinib or other drugs (control: methotrexate/other disease-modifying antirheumatic drugs/immunosuppressants). Disease activity was assessed over 3 years.

Results: The adherent comparative safety analysis set included 3731/2419 (tofacitinib/control) patients. Baseline (tofacitinib/control) biologic disease-modifying antirheumatic drug history (53.3%/12.2%), methotrexate history (81.4%/98.6%), and RA stage (I-II: 45.3%/67.1%) and class (1-2: 76.5%/90.8%) varied between groups. For tofacitinib vs control, incidence rates [patients with event/100 patient-years (95% confidence interval)] were 6.86 (5.96-7.86) vs 1.42 (0.97-2.00) for serious infections (adjusted hazard ratios 3.25-3.80); 1.40 (1.18-1.66) vs 0.88 (0.66-1.15) for malignancies (adjusted hazard ratios 1.37-1.53); 0.89 (0.72-1.10) vs 0.26 (0.15-0.43) for mortality (unadjusted hazard ratio 3.29). Remission/low disease activity rates with tofacitinib increased over 3 years.

Conclusions: Serious infection rates were higher, and malignancy rates were numerically higher with tofacitinib vs control. Results should be interpreted cautiously due to imbalanced groups and unmeasured confounders.

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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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