Brigham and Women's Hospital, Boston, Massachusetts.
Lithuanian University of Health Sciences, Kaunas, Lithuania.
Arthritis Rheumatol. 2018 Jan;70(1):40-48. doi: 10.1002/art.40336. Epub 2017 Nov 21.
OBJECTIVE: SB5 is a biosimilar agent for adalimumab (ADA). The aim of this study was to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of SB5 in comparison with reference ADA in patients with rheumatoid arthritis (RA). METHODS: In this phase III, randomized, double-blind, parallel-group study, patients with moderately to severely active RA despite treatment with methotrexate were randomized 1:1 to receive SB5 or reference ADA at a dosage of 40 mg subcutaneously every other week. The primary efficacy end point was the response rate based on the American College of Rheumatology 20% improvement criteria (ACR20) at week 24 in the per-protocol set (completer analysis). Additional end points included efficacy, PK, safety, and immunogenicity assessments. RESULTS: Of the 544 patients randomized to receive a study drug, the full analysis set comprised 542 patients (269 in the SB5 group, 273 in the reference ADA group) and the per-protocol set comprised 476 patients (239 receiving SB5, 237 receiving reference ADA). The ACR20 response rate at week 24 in the per-protocol set was equivalent between those receiving SB5 and those receiving reference ADA (72.4% and 72.2%, respectively); the difference in the ACR20 response rate (0.1%, [95% confidence interval -7.83%, 8.13%]) was within the predefined equivalence margin (±15%). Similar results were seen in the full analysis set (missing data being considered a nonresponse). The SB5 and reference ADA treatment groups were comparable across other end points, including the ACR 50% and ACR 70% improvement response rates, Disease Activity Score in 28 joints based on the erythrocyte sedimentation rate, PK data, incidence of treatment-emergent adverse events, and the antidrug antibody response. Subgroup analyses showed that the efficacy and safety of SB5 and reference ADA were comparable regardless of antidrug antibody status. CONCLUSION: The ACR20 response rate at week 24 was equivalent between patients treated with the biosimilar agent SB5 and those treated with reference ADA. SB5 and reference ADA were both well tolerated, with comparable safety profiles, in patients with RA.
目的：SB5 是一种阿达木单抗（ADA）的生物类似药。本研究旨在评估 SB5 与参照 ADA 相比在接受甲氨蝶呤治疗后仍处于中度至重度活跃期的类风湿关节炎（RA）患者中的疗效、药代动力学（PK）、安全性和免疫原性。
方法：在这项 III 期、随机、双盲、平行组研究中，接受过甲氨蝶呤治疗但病情仍处于中度至重度活跃期的 RA 患者按 1:1 随机分配，接受 SB5 或参照 ADA 治疗，剂量为每两周皮下注射 40mg。主要疗效终点为意向治疗人群（完全分析集）中第 24 周基于美国风湿病学会 20%改善标准（ACR20）的应答率。其他终点包括疗效、PK、安全性和免疫原性评估。
结果：在接受研究药物治疗的 544 名患者中，全分析集包括 542 名患者（SB5 组 269 名，参照 ADA 组 273 名），符合方案集包括 476 名患者（SB5 组 239 名，参照 ADA 组 237 名）。符合方案集患者第 24 周时的 ACR20 应答率在 SB5 组和参照 ADA 组之间相当（分别为 72.4%和 72.2%）；ACR20 应答率的差异（0.1%，95%置信区间 -7.83%，8.13%）在预设的等效边界内（±15%）。在全分析集中也观察到类似的结果（将缺失数据视为无应答）。SB5 和参照 ADA 治疗组在其他终点方面相似，包括 ACR50%和 ACR70%的改善应答率、基于红细胞沉降率的 28 个关节疾病活动度评分、PK 数据、治疗中出现的不良事件发生率和抗药物抗体反应。亚组分析显示，无论是否存在抗药物抗体，SB5 和参照 ADA 的疗效和安全性均相当。
结论：接受生物类似药 SB5 治疗的患者和接受参照 ADA 治疗的患者在第 24 周时的 ACR20 应答率相当。SB5 和参照 ADA 在 RA 患者中均具有良好的耐受性，安全性相似。
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