Rheumatology, Unidade Local de Saúde da Guarda; Unidade Local de Saúde do Alto Minho.
Rheumatology, Hospital Garcia da Orta.
ARP Rheumatol. 2022 Apr-Jun;1(2):109-116.
To compare the effectiveness and safety of original (Enbrel®) and biosimilar (Benepali®) etanercept in Biologic Disease-modifying Antirheumatic Drug (bDMARD)-naïve patients, measured by persistence rates over 36 months of follow-up.
A retrospective multicentre observational study using data collected prospectively from The Rheumatic Diseases Portuguese Registry (Reuma.pt) was performed, including patients with: age ≥ 18 years old; diagnosis of Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Spondyloarthritis (SpA) (axial or peripheral) with active disease and biologic-naïve who initiated treatment with etanercept as the first line biological treatment after 2010. Kaplan-Meyer and Cox regression were used to calculate the persistence rate in treatment. Disease activity at baseline and follow-up data at 6, 12, 18 and 24 months of treatment were compared. Causes for discontinuing therapy were summarized using descriptive statistics. Statistical significance was assumed for 2-sided p-values <0.05.
We included 1693 patients (413 on Benepali® and 1280 on Enbrel®): 864 diagnosed with RA, 335 with PsA and 494 with SpA. The 3-year persistence rates were not significantly different between both treatment groups in RA, PsA and SpA patients. In the adjusted Cox model, hazard ratios of discontinuation were not statistically different (p>0.05). The proportion of subjects in remission or low disease activity in each disease was similar in both groups. Overall, 535 (31.6%) patients discontinued etanercept (428 patients on Enbrel® and 107 patients on Benepali®). The major cause of discontinuation was inefficacy (57.8%). No differences for the occurrence of inefficacy or adverse effects were found between treatment groups.
Benepali® and Enbrel® demonstrated similar effectiveness and safety in RA, PsA and SpA in our cohort of patients. These data corroborate that the original and biosimilar drugs have similar quality characteristics and biological activity.
比较原研（恩利®）和生物类似药（倍利美®）依那西普在生物制剂初治患者中的疗效和安全性，通过 36 个月随访的持续率来衡量。
采用回顾性多中心观察性研究，使用前瞻性收集的来自葡萄牙风湿病登记处（Reuma.pt）的数据，包括年龄≥18 岁；诊断为类风湿关节炎（RA）、银屑病关节炎（PsA）或脊柱关节炎（SpA）（轴性或外周性），疾病活动且生物制剂初治，2010 年后开始依那西普作为一线生物治疗的患者。采用 Kaplan-Meier 和 Cox 回归计算治疗的持续率。比较基线和治疗后 6、12、18 和 24 个月的疾病活动数据。采用描述性统计总结停药原因。假设双侧 p 值<0.05 为具有统计学意义。
共纳入 1693 例患者（贝尼帕利®组 413 例，恩利®组 1280 例）：413 例诊断为 RA，335 例诊断为 PsA，494 例诊断为 SpA。在 RA、PsA 和 SpA 患者中，两组治疗 3 年的持续率无显著差异。在调整后的 Cox 模型中，停药的风险比无统计学差异（p>0.05）。两组患者在每个疾病中处于缓解或低疾病活动的患者比例相似。总体而言，535 例（31.6%）患者停用依那西普（恩利®组 428 例，贝尼帕利®组 107 例）。停药的主要原因是无效（57.8%）。两组之间未发现疗效或不良反应的发生率存在差异。
在我们的患者队列中，贝尼帕利®和恩利®在 RA、PsA 和 SpA 中显示出相似的疗效和安全性。这些数据证实了原研药和生物类似药具有相似的质量特征和生物学活性。
