Langevitz Pnina, Lidar Merav, Rosner Itzhak, Feld Joy, Tishler Moshe, Amital Howard, Aamar Suhail, Elkayam Ori, Balbir-Gurman Alexandra, Abu-Shakra Mahmoud, Mevorach Dror, Kimhi Oded, Molad Yair, Kuperman Ana, Ehrlich Sharon
Department of Rheumatology, Sheba Medical Center, Tel Hashomer, Israel.
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Isr Med Assoc J. 2020 Sep;22(9):557-563.
Tocilizumab is an interleukin 6 (IL-6) receptor antagonist used treat moderate to severe active rheumatoid arthritis (RA). Both intravenous (IV) and subcutaneous (SC) routes are approved for the treatment of adults with RA.
To evaluate SC tocilizumab in a real-life clinical setting.
Our study was a multi-center, open-label, single-arm study. Participants were adults with a diagnosis of active RA, previously treated with disease-modifying antirheumatic drugs (DMARDs), with or without biologic agents. Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or DMARDs for 24 weeks. Efficacy, safety, and immunogenicity were assessed.
Treatment of 100 patients over 24 weeks resulted in improvement in all efficacy parameters assessed: Clinical Disease Activity Index, Disease Activity Score using 28 joint counts and erythrocyte sedimentation rate, American College of Rheumatology response scores, Simplified Disease Activity Index, tender and swollen joint counts, and patient-reported outcomes including fatigue, global assessment of disease activity, pain, and Health Assessment Quality of Life Disease Index. Improvement was achieved as early as the second week of treatment. There were 473 adverse events (AEs)/100 patient-years (PY) and 16.66 serious AEs/100 PY. The most common AEs were neutropenia (12%), leukopenia (11%), and increased hepatic enzymes (11%). Of a total of 42 PY, the rates of serious infections and AEs leading to discontinuation were 4.8, and 11.9 events/100 PY, respectively.
The safety, tolerability, and efficacy profile of tocilizumab SC were comparable to those reported in other studies evaluating the IV and SC routes of administration.
托珠单抗是一种白细胞介素6（IL-6）受体拮抗剂，用于治疗中度至重度活动性类风湿关节炎（RA）。静脉注射（IV）和皮下注射（SC）途径均被批准用于治疗成人RA。
在现实临床环境中评估皮下注射托珠单抗。
我们的研究是一项多中心、开放标签、单臂研究。参与者为诊断为活动性RA的成年人，既往接受过改善病情抗风湿药物（DMARDs）治疗，无论是否使用过生物制剂。参与者接受每周一次皮下注射162mg托珠单抗，作为单一疗法或与甲氨蝶呤或DMARDs联合使用，共24周。评估疗效、安全性和免疫原性。
100例患者经过24周治疗后，所有评估的疗效参数均有改善：临床疾病活动指数、使用28个关节计数和红细胞沉降率的疾病活动评分、美国风湿病学会反应评分、简化疾病活动指数、压痛和肿胀关节计数，以及患者报告的结果，包括疲劳、疾病活动总体评估、疼痛和健康评估生活质量疾病指数。早在治疗的第二周就实现了改善。每100患者年（PY）有473例不良事件（AE），每100 PY有16.66例严重AE。最常见的AE是中性粒细胞减少（12%）、白细胞减少（11%）和肝酶升高（11%）。在总共42 PY中，严重感染和导致停药的AE发生率分别为每100 PY 4.8例和11.9例。
皮下注射托珠单抗的安全性、耐受性和疗效与其他评估静脉注射和皮下注射给药途径的研究报告相当。
