A retrospective chart review to explore the efficacy and safety of switching to peficitinib in Japanese patients with rheumatoid arthritis and inadequate response to biologic disease-modifying antirheumatic drugs.

IF 1.9 4区 医学 Q3 RHEUMATOLOGY
Kunihiro Yamaoka, Junichi Kondo, Toshinori Furuya, Yusuke Tanaka, Tadatsura Koshika, Yoshiaki Morita, Kenji Oku
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引用次数: 0

Abstract

Objectives: This retrospective, observational study examined the safety and efficacy of the Janus kinase inhibitor peficitinib in Japanese patients with rheumatoid arthritis who switched to peficitinib due to inadequate response to biologic disease-modifying antirheumatic drugs.

Methods: We included patients aged ≥ 20 years with rheumatoid arthritis who switched to peficitinib between 10 July 2019 and 31 March 2022 and were enrolled in peficitinib post-marketing surveillance. The primary endpoint was change in disease activity score in 28 joints with erythrocyte sedimentation rate (DAS28-ESR) from index date to 24 weeks. Secondary endpoints included change in Clinical Disease Activity Index and adverse event incidence.

Results: Of 76 enrolled patients, efficacy data were available for 67; 56 completed 24 weeks of treatment. One-quarter (19/76) of patients reported adverse events; 16 (21.1%) had drug-related adverse events with one (streptococcal infection) considered serious. From index date to 24 weeks, mean (standard deviation) change in DAS28-ESR was -0.95 (1.24) (95% confidence interval [CI]: -1.26, -0.65; P < .0001) and in Clinical Disease Activity Index was -7.82 (8.52) (95% CI: -9.90, -5.74; P < .0001). Improvements in DAS28-ESR and Clinical Disease Activity Index by 12 and 24 weeks were statistically significant regardless of prior number of biologic disease-modifying antirheumatic drugs.

Conclusions: Peficitinib could be an effective treatment option for patients with rheumatoid arthritis refractory to biologic disease-modifying antirheumatic drugs.

一项回顾性图表回顾,旨在探讨日本类风湿性关节炎患者改用非西替尼的疗效和安全性,这些患者对生物疾病缓解抗风湿药物反应不足。
目的:这项回顾性观察性研究检查了Janus激酶抑制剂培非西替尼在日本类风湿性关节炎(RA)患者中的安全性和有效性,这些患者由于对生物疾病缓解抗风湿药物(bDMARDs)的反应不足而改用培非西替尼。方法:我们纳入了年龄≥20岁的RA患者,这些患者在2019年7月10日至2022年3月31日期间切换到培非替尼,并参加了培非替尼上市后的监测。主要终点是28个关节的疾病活动性评分与红细胞沉降率(DAS28-ESR)从指数日期到24周的变化。次要终点包括临床疾病活动指数(CDAI)和不良事件(AE)发生率的变化。结果:76例入组患者中,67例获得疗效数据;56例完成24周治疗。1 / 4(19/76)的患者报告不良事件;16例(21.1%)有药物相关不良反应,其中1例(链球菌感染)被认为是严重的。从指数日期到24周,DAS28-ESR的平均(标准差)变化为-0.95(1.24)(95%置信区间[CI]: -1.26, -0.65;结论:对于bdmard难治性RA患者,非西替尼可能是一种有效的治疗选择。
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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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