阿达木单抗治疗日本幼年特发性关节炎患者的安全性和有效性：一项真实世界的上市后研究结果。
Safety and effectiveness of adalimumab in Japanese patients with juvenile idiopathic arthritis: Results from a real-world postmarketing study.
机构信息
Department of Pediatrics, Kagoshima University, Kagoshima, Japan.
Aichi Children's Health and Medical Center, Obu, Aichi, Japan.
出版信息
Mod Rheumatol. 2021 Mar;31(2):421-430. doi: 10.1080/14397595.2020.1761075. Epub 2020 May 18.
OBJECTIVES
This study was conducted to assess the real-world safety and effectiveness of adalimumab in patients with juvenile idiopathic arthritis (JIA).
METHODS
In this all-case, postmarketing surveillance study (NCT01412021) conducted in Japan, patients receiving adalimumab for JIA affecting multiple joints were observed for 24 weeks. The safety (adverse drug reactions [ADRs]/serious ADRs) and effectiveness (4-variable Disease Activity Score in 28 joints using erythrocyte sedimentation rate [DAS28-4/ESR] remission rate) were assessed.
RESULTS
In the safety population ( = 356), 90.3% (65/72; weight, ≥15-<30 kg) of patients received adalimumab 20 mg every 2 weeks (q2w) and 98.3% (236/240; weight ≥30 kg) received 40 mg q2w. Incidence of ADRs and serious ADRs was 29.8% (106/356) and 3.4% (12/356), respectively. Incidence of ADRs was significantly higher in patients aged <15 years vs. ≥15 years (34.6% vs. 21.1%, = .0072), those with comorbidities vs. without (38.3% vs. 25.7%, = .0155), and those receiving dose <40 mg q2w vs. ≥40 mg q2w (38.8% vs. 26.9%, = .0418). DAS28-4/ESR remission rate improved from 21.7% (36/166) at baseline to 74.7% (112/150) at week 24.
CONCLUSIONS
Adalimumab was well tolerated and had acceptable safety and effectiveness in patients with JIA in the real-world setting.
目的
本研究旨在评估阿达木单抗治疗幼年特发性关节炎（JIA）患者的真实世界安全性和有效性。
方法
本研究是一项在日本开展的全病例、上市后监测研究（NCT01412021），共纳入接受阿达木单抗治疗、多关节受累的 JIA 患者，观察 24 周。评估安全性（药物不良反应/严重药物不良反应）和有效性（红细胞沉降率 4 变量 28 关节疾病活动度评分[DAS28-4/ESR]缓解率）。
结果
在安全性人群（n=356）中，90.3%（65/72；体重≥15-<30kg）的患者接受每 2 周（q2w）20mg 阿达木单抗治疗，98.3%（236/240；体重≥30kg）接受 40mg q2w 治疗。药物不良反应和严重药物不良反应的发生率分别为 29.8%（106/356）和 3.4%（12/356）。年龄<15 岁的患者药物不良反应发生率显著高于年龄≥15 岁的患者（34.6% vs. 21.1%，P=0.0072），合并症患者显著高于无合并症患者（38.3% vs. 25.7%，P=0.0155），接受剂量<40mg q2w 的患者显著高于接受剂量≥40mg q2w 的患者（38.8% vs. 26.9%，P=0.0418）。基线时 DAS28-4/ESR 缓解率为 21.7%（36/166），治疗 24 周时缓解率提高至 74.7%（112/150）。
结论
阿达木单抗在真实世界环境中治疗 JIA 患者，具有良好的耐受性，且安全性和有效性可接受。
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