Peking University People's Hospital, Beijing, China.
Jiangxi Pingxiang People's Hospital, Pingxiang, China.
Adv Ther. 2021 Jan;38(1):772-781. doi: 10.1007/s12325-020-01572-y. Epub 2020 Nov 25.
Baricitinib is an oral, selective inhibitor of Janus kinase which demonstrates clinical efficacy in patients with rheumatoid arthritis (RA). This report aims to analyze the onset time of baricitinib in Chinese patients with moderately to severely active RA who had an inadequate response to methotrexate.
This post hoc analysis evaluated clinical improvements of Chinese patients treated with baricitinib 4 mg once daily compared with placebo, based on data from a phase 3 study RA-BALANCE. Efficacy measures including American College of Rheumatology 20% (ACR20) response, ACR core set values, Disease Activity Score modified to include the 28 diarthrodial joint count (DAS28) using high-sensitivity C-reactive protein (hsCRP), DAS28-erythrocyte sedimentation rate, Simplified Disease Activity Index, Clinical Disease Activity Index, DAS28-hsCRP ≤ 3.2 response (low disease activity), and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were evaluated at weeks 1, 2, 4, 8, 12, 14, 16, 20, and 24 (except for FACIT-F evaluated every 4 weeks). A logistic regression model and an analysis of covariance model were used to analyze treatment comparisons of categorical and continuous measures, respectively.
Statistically significant (p ≤ 0.05) improvements were observed as early as week 1 or 2 for the baricitinib group compared to placebo in almost all main efficacy measures. For other outcomes including 66 swollen joint count, 68 tender joint count, FACIT-F, and DAS28-hsCRP ≤ 3.2 response rate, differences were evident (p ≤ 0.05) by week 4 in the baricitinib group compared with placebo. Significant improvements in all efficacy measures were sustained through 24 weeks.
Baricitinib demonstrated a rapid onset of efficacy on ACR20 response, ACR core set values, disease activity, and patient-reported outcome improvements in Chinese patients from RA-BALANCE.
ClinicalTrials.gov identifier, NCT02265705.
巴瑞替尼是一种口服、选择性 Janus 激酶抑制剂，在对甲氨蝶呤治疗反应不足的类风湿关节炎（RA）患者中显示出临床疗效。本报告旨在分析巴瑞替尼在中国中重度活动型 RA 患者中的起效时间，这些患者对甲氨蝶呤治疗反应不足。
这项事后分析评估了来自 RA-BALANCE 三期研究中接受巴瑞替尼 4mg 每日一次治疗的中国患者的临床改善情况，与安慰剂相比。疗效评估包括美国风湿病学会 20%（ACR20）应答、ACR 核心量表值、包括 28 个关节计数的疾病活动评分（DAS28）改良版（采用高敏 C 反应蛋白[hsCRP]）、DAS28-红细胞沉降率、简化疾病活动指数、临床疾病活动指数、DAS28- hsCRP≤3.2 应答（低疾病活动）和慢性疾病治疗疲劳功能评估-疲劳（FACIT-F），在第 1、2、4、8、12、14、16、20 和 24 周（除 FACIT-F 每 4 周评估一次外）进行评估。采用逻辑回归模型和协方差分析模型分别分析分类和连续测量的治疗比较。
与安慰剂相比，巴瑞替尼组在几乎所有主要疗效测量中，从第 1 周或第 2 周开始就观察到统计学上显著（p≤0.05）的改善。对于其他结局，包括 66 个肿胀关节计数、68 个压痛关节计数、FACIT-F 和 DAS28-hsCRP≤3.2 应答率，巴瑞替尼组在第 4 周时与安慰剂相比差异显著（p≤0.05）。所有疗效测量指标的改善在 24 周时持续存在。
在 RA-BALANCE 研究中，巴瑞替尼在中国患者中显示出 ACR20 应答、ACR 核心量表值、疾病活动度和患者报告结局改善的快速起效。
ClinicalTrials.gov 标识符，NCT02265705。
