Kotake Kazumasa, Mitsuboshi Satoru
Pharmacy Department, Zikei Hospital/Zikei Institute of Psychiatry, Okayama, JPN.
Pharmacy Department, Kaetsu Hospital, Niigata, JPN.
Cureus. 2024 Jun 14;16(6):e62372. doi: 10.7759/cureus.62372. eCollection 2024 Jun.
Tofacitinib is one of the Janus kinase inhibitors approved for the treatment of rheumatoid arthritis. The major adverse event of this drug is herpes zoster, which can lead to death in severe cases. The risk of herpes zoster has been studied at 10 mg/day of tofacitinib; however, 5 mg/day, which is recommended in patients with chronic kidney disease, is unclear.
To investigate whether 5 mg/day of tofacitinib reduced the risk of herpes zoster compared with 10 mg/day in rheumatoid arthritis patients.
We analyzed the Japanese Adverse Drug Event Report Data (JADER) database and compared the frequency of herpes zoster in rheumatoid arthritis patients treated with tofacitinib 5 mg/day and 10 mg/day. Multivariable logistic regression analysis was performed to identify the risk factors for herpes zoster in tofacitinib users.
A total of 812 tofacitinib users with rheumatoid arthritis were identified, including 131 with herpes zoster. Disproportionality for herpes zoster was observed between 5 mg/day and 10 mg/day (reporting odds ratio (OR): 0.68, 95% confidence interval (CI): 0.47-0.98, P = 0.045). Multivariable logistic regression analysis showed that the risk of herpes zoster was significantly increased in female patients (OR: 1.87, 95% CI: 1.12-3.12, P = 0.016) and methotrexate users (OR: 1.69, 95% CI: 1.12-2.54, P = 0.013) and significantly decreased with tofacitinib 5 mg/day compared with 10 mg/day (OR: 0.62, 95% CI: 0.40-0.96, P = 0.032).
We suggest that tofacitinib 5 mg/day may decrease the risk of herpes zoster compared with 10 mg/day in rheumatoid arthritis patients.
托法替布是一种被批准用于治疗类风湿性关节炎的 Janus 激酶抑制剂。该药物的主要不良事件是带状疱疹，严重时可导致死亡。已对托法替布每日 10 毫克剂量时的带状疱疹风险进行了研究；然而，对于慢性肾病患者推荐的每日 5 毫克剂量，其情况尚不清楚。
探讨类风湿性关节炎患者中，与每日 10 毫克剂量相比，每日 5 毫克剂量的托法替布是否能降低带状疱疹风险。
我们分析了日本药品不良反应报告数据（JADER）数据库，并比较了接受每日 5 毫克和 10 毫克剂量托法替布治疗的类风湿性关节炎患者中带状疱疹的发生频率。进行多变量逻辑回归分析以确定托法替布使用者发生带状疱疹的风险因素。
共识别出 812 名使用托法替布的类风湿性关节炎患者，其中 131 人患有带状疱疹。观察到每日 5 毫克和 10 毫克剂量组之间带状疱疹的不成比例性（报告比值比（OR）：0.68，95%置信区间（CI）：0.47 - 0.98，P = 0.045）。多变量逻辑回归分析表明，女性患者（OR：1.87，95%CI：1.12 - 3.12，P = 0.016）和使用甲氨蝶呤的患者（OR：1.69，95%CI：1.12 - 2.54，P = 0.013）发生带状疱疹的风险显著增加，与每日 10 毫克剂量相比，每日 5 毫克剂量的托法替布使风险显著降低（OR：0.62，95%CI：0.40 - 0.96，P = 0.032）。
我们认为，在类风湿性关节炎患者中，与每日 10 毫克剂量相比，每日 5 毫克剂量的托法替布可能会降低带状疱疹风险。
