Carballo Nuria, Pérez García Carolina, Grau Santiago, Monfort Jordi, Durán-Jordà Xavier, Echeverría-Esnal Daniel, Ferrández Olivia
Pharmacy Department, Hospital del Mar-Parc de Salut Mar, Barcelona, Spain.
Universitat Autònoma de Barcelona, Barcelona, Spain.
Front Pharmacol. 2022 Oct 3;13:980832. doi: 10.3389/fphar.2022.980832. eCollection 2022.
Although several randomized clinical trials have confirmed that there is no difference in efficacy between etanercept and its biosimilar versions in the treatment of rheumatoid arthritis (RA), limited real-world evidence is available. We conducted a cohort study to compare the effectiveness and treatment persistence between the reference etanercept (ETN) and the biosimilar GP2015 in RA patients in a real-life setting. Adults with a diagnosis of RA who initiated treatment with ETN or GP2015, between January 2007 and December 2019, were included. The follow-up period was 52 weeks. The primary outcome was the mean of change in the DAS28-CRP values and the adjusted mean difference from baseline to 52 weeks between ETN and GP2015. Other effectiveness endpoints assessed were the rate of patients who achieved remission or low disease activity (LDA) at week 52, who showed a reduction of DAS28-CRP value greater than or equal to 1.2 from baseline to week 52 and rate of good responder patients (those meeting both effectiveness measures) at week 52. Treatment effectiveness over time (baseline, 26 and 52 weeks) was compared between the ETN and GP2015 groups using mixed effects models. Treatment persistence (probability of maintaining the same treatment over time) was also evaluated and shown using Kaplan-Meier survival curves. A total of 115 RA patients were included (ETN, = 90; GP2015, = 25). No differences were observed in the primary outcome: DAS28-CRP score decreased from baseline to week 52 [5.1 to 2.7 (mean of change -2.37) in ETN group and 5.0 to 2.2 (mean of change -2.84) in GP2015 group, -value = 0.372] and the adjusted mean difference was -0.37 (-1.03 to 0.29). No differences were also observed in the other effectiveness endpoints assessed among patients treated with ETN or GP2015: rate of patients who achieved remission (54.1% vs. 66.7%, -value = 0.303) and LDA (71.6% vs. 80.9%, -value = 0.391) at week 52, reduction of DAS28-CRP value greater than or equal to 1.2 from baseline to week 52 (75.6% vs. 80.9%, -value = 0.613) and rate of good responder patients (58.1% vs. 76.1%, -value = 0.202). Drug survival was 82% and 80% for ETN and GP2015, respectively (log-rank -value = 0.804). Etanercept and its biosimilar GP2015 show similar effectiveness and treatment persistence in RA patients in a real-life setting.
尽管多项随机临床试验已证实，在治疗类风湿关节炎（RA）方面，依那西普与其生物类似药版本在疗效上并无差异，但实际应用中的证据有限。我们开展了一项队列研究，以比较在现实环境中，参比依那西普（ETN）与生物类似药GP2015在RA患者中的有效性和治疗持续性。纳入了2007年1月至2019年12月期间开始使用ETN或GP2015进行治疗的成年RA患者。随访期为52周。主要结局是DAS28-CRP值的变化均值以及ETN和GP2015从基线到52周的校正均值差异。评估的其他有效性终点包括在第52周达到缓解或低疾病活动度（LDA）的患者比例、从基线到第52周DAS28-CRP值降低大于或等于1.2的患者比例以及在第52周达到良好反应的患者（同时满足两项有效性指标）比例。使用混合效应模型比较了ETN组和GP2015组随时间（基线、26周和52周）的治疗有效性。还评估了治疗持续性（随时间维持相同治疗的概率），并使用Kaplan-Meier生存曲线进行展示。共纳入115例RA患者（ETN组90例；GP2015组25例）。在主要结局方面未观察到差异：ETN组DAS28-CRP评分从基线降至第52周[从5.1降至2.7（变化均值-2.37）]，GP2015组从5.0降至2.2（变化均值-2.84），P值=0.372，校正均值差异为-0.37（-1.03至0.29）。在接受ETN或GP2015治疗的患者中，评估的其他有效性终点也未观察到差异：第52周达到缓解的患者比例（54.1%对66.7%，P值=0.303）和LDA的患者比例（71.6%对80.9%，P值=0.391）、从基线到第52周DAS-28CRP值降低大于或等于1.2的患者比例（75.6%对80.9%，P值=0.613）以及良好反应患者比例（58.1%对76.1%，P值=0.202）。ETN和GP2015的药物留存率分别为82%和80%（对数秩检验P值=0.804）。在现实环境中，依那西普及其生物类似药GP2015在RA患者中显示出相似的有效性和治疗持续性。
