Maeyama Akira, Kondo Masakazu, Harada Hiroshi, Shono Eisuke, Nagamine Ryuji, Tsuru Tomomi, Inoue Yasushi, Nakashima Munetoshi, Yamasaki Yutaro, Niiro Hiroaki, Nakashima Yasuharu, Yamamoto Takuaki
Department of Orthopaedic Surgery, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.
Kondo Clinic of Rheumatology and Orthopaedic Surgery, 3-10-11 Tenjin, Chuo-ku, Fukuoka, 810-0001, Japan.
BMC Rheumatol. 2024 Dec 18;8(1):69. doi: 10.1186/s41927-024-00446-y.
This study aimed to compare the efficacy and safety of baricitinib in patients with rheumatoid arthritis (RA) receiving different doses based on renal function.
We conducted a retrospective study within the JAK Study Group, involving 23 facilities in Fukuoka Prefecture, examining patients treated with baricitinib for RA. Patients were categorized into two dose groups: 4 mg with normal/mild renal dysfunction and 2 mg with moderate renal dysfunction. Baricitinib's efficacy, retention rate, and safety were compared between the groups after propensity score matching.
After propensity score matching, disease duration, methotrexate dosage, and anti-cyclic citrullinated peptide antibody positivity rate were balanced across 33 patients in both groups. No significant differences were observed between the groups in tender/swollen joint counts, changes in evaluator/patient global assessments, achievement rate of low disease activity, remission rate on clinical/simplified disease activity indices, or retention rate. Additionally, the incidence of adverse events aligned with previous reports, indicating similar drug safety profiles.
Baricitinib 2 mg in RA patients with moderate renal dysfunction showed comparable efficacy and retention rate to 4 mg in patients with normal/mild renal dysfunction. The incidence and types of adverse events were consistent with previous studies, indicating the safety of the drug at these dosages.
本研究旨在比较类风湿关节炎（RA）患者中，基于肾功能给予不同剂量巴瑞替尼的疗效和安全性。
我们在JAK研究组内开展了一项回顾性研究，涉及福冈县的23家医疗机构，研究对象为接受巴瑞替尼治疗RA的患者。患者被分为两个剂量组：肾功能正常/轻度不全者服用4毫克，中度肾功能不全者服用2毫克。在倾向得分匹配后，比较两组中巴瑞替尼的疗效、保留率和安全性。
倾向得分匹配后，两组的33例患者在病程、甲氨蝶呤剂量和抗环瓜氨酸肽抗体阳性率方面达到平衡。两组在压痛/肿胀关节计数、评估者/患者整体评估变化、低疾病活动度达成率、临床/简化疾病活动指数缓解率或保留率方面均未观察到显著差异。此外，不良事件的发生率与既往报告一致，表明药物安全性特征相似。
中度肾功能不全的RA患者服用2毫克巴瑞替尼，其疗效和保留率与肾功能正常/轻度不全患者服用4毫克相当。不良事件的发生率和类型与既往研究一致，表明这些剂量下药物的安全性。
