Okamoto Nami, Atsumi Tatsuya, Takagi Michiaki, Takahashi Nobunori, Takeuchi Tsutomu, Tamura Naoto, Nakajima Atsuo, Nakajima Ayako, Fujii Takao, Matsuno Hiroaki, Ishii Taeko, Tsujimoto Naoto, Nishikawa Atsushi, Minatoya Machiko, Tanaka Yoshiya, Kuwana Masataka
Department of Paediatrics, Osaka Rosai Hospital, Osaka, Japan.
Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University, Hokkaido, Japan.
Mod Rheumatol. 2025 Feb 21;35(2):215-224. doi: 10.1093/mr/roae064.
To assess safety of baricitinib in Japanese patients with rheumatoid arthritis (RA) in real-world clinical practice.
This all-case postmarketing surveillance study included patients initiating baricitinib for RA from September 2017 to April 2019. Treatment duration was recorded. Safety data were collected for up to 3 years from initiation (up to 4 weeks postdiscontinuation in discontinuing patients).
Safety analyses included 4720 patients; 2580 (54.7%) were ≥65 years old. Baricitinib persistence rate was 45.4% (3-year Kaplan-Meier analysis); the most common discontinuation reason was insufficient effectiveness (n = 1005, 21.3%). Serious adverse events occurred in 600 patients [incidence rate (IR) 10.42/100 patient-years (PY); 95% confidence interval, 9.76-11.09]. There were 39 deaths [IR 0.43 (0.30-0.57)/100 PY]. Adverse events of special interest IRs per 100 PY were herpes zoster 4.68 (4.22-5.14), serious infection 3.05 (2.68-3.41), malignancy 1.09 (0.87-1.30), major adverse cardiovascular events 0.35 (0.23-0.48), and venous thromboembolism 0.25 (0.15-0.36). IRs did not increase with prolonged exposure.
No new safety concerns were identified during this 3-year postmarketing surveillance study of baricitinib in Japanese patients with RA. Patients and clinicians should be cognizant of herpes zoster and other serious infection risks during baricitinib treatment, especially in the first 6 months.
在真实世界临床实践中评估巴瑞替尼在日本类风湿关节炎（RA）患者中的安全性。
这项全病例上市后监测研究纳入了2017年9月至2019年4月开始使用巴瑞替尼治疗RA的患者。记录治疗持续时间。从开始治疗起收集长达3年的安全性数据（停药患者在停药后最多4周）。
安全性分析纳入了4720例患者；2580例（54.7%）年龄≥65岁。巴瑞替尼持续治疗率为45.4%（3年Kaplan-Meier分析）；最常见的停药原因是疗效不佳（n = 1005，21.3%）。600例患者发生严重不良事件[发病率（IR）为10.42/100患者年（PY）；95%置信区间为9.76 - 11.09]。有39例死亡[IR为0.43（0.30 - 0.57）/100 PY]。每100 PY中特别关注的不良事件IR分别为带状疱疹4.68（4.22 - 5.14）、严重感染3.05（2.68 - 3.41）、恶性肿瘤1.09（0.87 - 1.30）、主要不良心血管事件0.35（0.23 - 0.48）和静脉血栓栓塞0.25（0.15 - 0.36）。IR并未随着暴露时间延长而增加。
在这项针对日本RA患者的巴瑞替尼3年上市后监测研究中，未发现新的安全性问题。患者和临床医生在巴瑞替尼治疗期间应认识到带状疱疹和其他严重感染风险，尤其是在最初6个月。
