Kivitz Alan, Baret-Cormel Lydie, van Hoogstraten Hubert, Wang Sheldon, Parrino Janie, Xu Christine, Stanislav Marina
Altoona Center for Clinical Research, Duncansville, PA, USA.
Sanofi, Paris, France.
Rheumatol Ther. 2018 Jun;5(1):231-242. doi: 10.1007/s40744-017-0090-2. Epub 2017 Dec 5.
Sarilumab is a human monoclonal antibody that blocks the interleukin-6 receptor alpha (IL-6Rα). The phase 3 SARIL-RA-EASY study (EASY) assessed the robustness of an autoinjector (pen) for administering sarilumab when used by adults with active moderate-to-severe rheumatoid arthritis (RA) who are candidates for anti-IL-6R therapy in an unsupervised real-world setting.
EASY was a 12-week, multicenter, randomized, open-label, parallel-group usability study of the sarilumab pen and prefilled syringe. Patients were randomized 1:1:1:1 to sarilumab 150 or 200 mg every 2 weeks (q2w) administered via pen or syringe, plus background disease-modifying antirheumatic drugs. Patients reported their ability to remove the pen cap and initiate and complete injections; negative responses were defined as product technical complaints (PTCs). The primary endpoint was the number of validated product technical failures (PTFs; PTC with a validated technical cause). This study was not powered to demonstrate bioequivalence or differences in efficacy among groups.
A total of 217 patients were randomized. There were 600 successful injections with the sarilumab pen in 108 patients and no pen-associated PTFs. One PTC was observed (the pen was mistakenly activated before injection). At week 12, 88% of patients indicated the pen was "easy" to use, and 98% reported they were "satisfied" with the pen. Proportions of patients achieving an American College of Rheumatology 20/50/70 response and a 28-joint disease activity score by C-reactive protein < 2.6 were similar at each dose between the pen and syringe groups, as were the pharmacokinetics. There were no clinically meaningful differences in adverse events (AEs), serious AEs, and AEs leading to discontinuation in the pen and syringe groups. The most common treatment-emergent AEs were infections and neutropenia.
This study demonstrated the ease of use and robustness of the sarilumab pen when used by patients with RA in an unsupervised setting. Pharmacokinetics, safety, and efficacy were generally similar for the pen and syringe groups (NCT02057250).
Sanofi Genzyme and Regeneron Pharmaceuticals, Inc.
Clinicaltrials.gov identifier, NCT02057250.
萨立鲁单抗是一种可阻断白细胞介素-6受体α（IL-6Rα）的人源单克隆抗体。3期SARIL-RA-EASY研究（EASY）评估了自动注射器（笔式注射器）在无监督的真实环境中供患有活动性中重度类风湿性关节炎（RA）且适合接受抗IL-6R治疗的成人使用时，用于注射萨立鲁单抗的稳健性。
EASY是一项为期12周的多中心、随机、开放标签、平行组可用性研究，对比了萨立鲁单抗笔式注射器和预填充注射器。患者按1:1:1:1随机分组，分别接受每2周（q2w）一次、剂量为150或200mg的萨立鲁单抗笔式注射器或注射器注射，并加用背景改善病情抗风湿药物。患者报告其取下笔帽、开始并完成注射的能力；负面反应被定义为产品技术投诉（PTC）。主要终点是经过验证的产品技术故障（PTF；有经过验证技术原因的PTC）数量。本研究未设定用于证明各组间生物等效性或疗效差异。
共217例患者被随机分组。108例患者使用萨立鲁单抗笔式注射器成功注射600次，未出现与笔式注射器相关的PTF。观察到1次PTC（注射前笔式注射器被误激活）。在第12周时，88%的患者表示笔式注射器“易于”使用，98%的患者报告他们对笔式注射器“满意”。笔式注射器组和注射器组在各剂量下达到美国风湿病学会20/50/70反应以及基于C反应蛋白的28关节疾病活动评分<2.6的患者比例相似，药代动力学情况也相似。笔式注射器组和注射器组在不良事件（AE）、严重AE以及导致停药的AE方面无临床意义上的差异。最常见的治疗中出现的AE是感染和中性粒细胞减少。
本研究证明了萨立鲁单抗笔式注射器在无监督环境中供RA患者使用时的易用性和稳健性。笔式注射器组和注射器组的药代动力学、安全性和疗效总体相似（NCT02057250）。
赛诺菲安万特公司和再生元制药公司
Clinicaltrials.gov标识符，NCT02057250
