依那西普生物类似药转换治疗与继续使用依那西普治疗对病情稳定的类风湿关节炎患者的疗效：一项前瞻性多国观察性研究。

Post-switch Effectiveness of Etanercept Biosimilar Versus Continued Etanercept in Rheumatoid Arthritis Patients with Stable Disease: A Prospective Multinational Observational Study.

机构信息

University of Western Ontario and St. Joseph's Hospital, London, ON, Canada.

Cabrini Medical Center, Malvern, VIC, Australia.

出版信息

Adv Ther. 2022 Nov;39(11):5259-5273. doi: 10.1007/s12325-022-02303-1. Epub 2022 Sep 22.

DOI:10.1007/s12325-022-02303-1

PMID:36136243

Abstract

INTRODUCTION

To better inform clinicians about the use of etanercept biosimilar (SB4) in patients with rheumatoid arthritis (RA), COMPANION-B, a prospective real-world observational study, evaluated the effectiveness of the voluntary switch from originator (etanercept, ETN) to SB4 in patients with stable RA (low-disease activity/remission).

METHODS

The study recruited adult patients (18 years or older) with RA (2010 American College of Rheumatology criteria) prescribed ETN as their first or second biologic for at least 6 months across 14 sites in Canada and five in Australia. Patients had stable disease (Disease Activity Score-28 using erythrocyte sedimentation rate [DAS28-ESR] less than 3.2) at enrollment with no evidence of flare within the previous 3 months. Concomitant disease-modifying antirheumatic drugs (DMARDs) were permitted. Patients could elect to continue ETN or voluntarily switch to SB4 in consultation with their doctors. The primary effectiveness measure was the proportion of patients with disease worsening (defined as a DAS28-ESR increase of at least 1.2 from baseline and minimum score of at least 3.2 or a defined modification in RA treatment) during 12 months of follow-up. The secondary effectiveness measure was the proportion of patients with disease worsening at month 6. Serious adverse events (SAEs) and non-serious adverse reactions (NSARs) were recorded.

RESULTS

Of 163 patients enrolled, 109 elected to continue on ETN and 54 switched to SB4; 65.8% of patients received non-biologic DMARD(s), 52.6% methotrexate, and 10.5% oral corticosteroid(s). At month 12, the proportion of patients with disease worsening was comparable in the ETN group (22.8% [95% CI 15.0-32.2]) and SB4 group (17.6% [95% CI 8.4-30.9]). Similarly, the proportions of patients with disease worsening were also comparable at month 6 (ETN: 7.9% [95% CI 3.5-15.0]; SB4: 7.8% [95% CI 2.2-18.9]). SAEs were low and similar across both groups (ETN: 8.7%; SB4: 5.7%). NSARs were slightly higher in the SB4 vs. ETN group (13.2% vs. 2.9%).

CONCLUSIONS

SB4 demonstrated comparable effectiveness to ETN over 12 months in patients with stable RA who voluntarily switched to the biosimilar in a real-world setting.

摘要

简介

为了让临床医生更好地了解依那西普生物类似药（SB4）在类风湿关节炎（RA）患者中的应用，COMPANION-B 是一项前瞻性真实世界观察研究，评估了在病情稳定的 RA 患者（疾病活动度低/缓解）中，从原研药（依那西普，ETN）自愿转换为 SB4 的疗效。

方法

该研究招募了来自加拿大 14 个和澳大利亚 5 个地点的年龄在 18 岁或以上的 RA 患者（2010 年美国风湿病学会标准），至少接受了 6 个月的 ETN 或其作为二线生物制剂治疗。患者在入组时疾病稳定（红细胞沉降率 [ESR] 计算的 DAS28 低于 3.2），且在过去 3 个月内无疾病活动迹象。允许同时使用疾病改善抗风湿药物（DMARDs）。患者可与医生协商后选择继续使用 ETN 或自愿转换为 SB4。主要疗效指标是在 12 个月的随访期间病情恶化（定义为 DAS28-ESR 自基线增加至少 1.2，且最低评分至少为 3.2 或 RA 治疗的明确改变）的患者比例。次要疗效指标是在第 6 个月病情恶化的患者比例。记录严重不良事件（SAE）和非严重不良反应（NSAR）。

结果

在 163 名入组患者中，109 名患者选择继续使用 ETN，54 名患者转换为 SB4；65.8%的患者接受了非生物 DMARD（s），52.6%的患者接受了甲氨蝶呤，10.5%的患者接受了口服皮质类固醇（s）。在第 12 个月时，ETN 组（22.8%[95%CI 15.0-32.2]）和 SB4 组（17.6%[95%CI 8.4-30.9]）的病情恶化患者比例相似。同样，在第 6 个月时，病情恶化的患者比例也相似（ETN：7.9%[95%CI 3.5-15.0]；SB4：7.8%[95%CI 2.2-18.9]）。两组的 SAE 均较低且相似（ETN：8.7%；SB4：5.7%）。SB4 组的 NSAR 略高于 ETN 组（13.2%比 2.9%）。