Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria.
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Rheumatology (Oxford). 2021 May 14;60(5):2256-2266. doi: 10.1093/rheumatology/keaa576.
To evaluate the long-term efficacy of once-daily baricitinib 4 mg in patients with active RA who were either naïve to DMARDs or who had inadequate response (IR) to MTX.
Analyses of data from two completed 52-week, phase III studies, RA-BEGIN (DMARD-naïve) and RA-BEAM (MTX-IR), and one ongoing long-term extension (LTE) study (RA-BEYOND) were performed (148 total weeks). At week 52, DMARD-naïve patients treated with MTX monotherapy or baricitinib 4 mg+MTX in RA-BEGIN were switched to open-label baricitinib 4 mg monotherapy; MTX-IR patients treated with adalimumab (+MTX) in RA-BEAM were switched to open-label baricitinib 4 mg (+MTX) in the LTE. Patients who received placebo (+MTX) were switched to baricitinib 4 mg (+MTX) at week 24. Low disease activity (LDA) [Simple Disease Activity Index (SDAI) ≤11], clinical remission (SDAI ≤ 3.3), and physical functioning [Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ 0.5] were assessed. Data were assessed using a non-responder imputation.
At week 148, SDAI LDA was achieved in up to 61% of DMARD-naïve patients and 59% of MTX-IR patients initially treated with baricitinib, and SDAI remission was achieved in up to 34% of DMARD-naïve patients and 24% of MTX-IR patients; HAQ-DI ≤ 0.5 was reached in up to 48% of DMARD-naïve patients and 38% of MTX-IR patients initially treated with baricitinib. Over 148 weeks, 3.6% and 10.7% of MTX-IR patients discontinued across treatment groups due to lack of efficacy or due to adverse events, respectively; discontinuation rates were similar in the DMARD-naïve population.
Treatment with baricitinib 4 mg demonstrated efficacy for up to 3 years and was well tolerated.
评估每日一次巴瑞替尼 4mg 对初治或甲氨蝶呤治疗应答不足的活动性类风湿关节炎患者的长期疗效。
对两项已完成的 52 周、III 期研究 RA-BEGIN（初治）和 RA-BEAM（MTX 应答不足）以及一项正在进行的长期扩展（LTE）研究 RA-BEYOND 的数据进行分析（共 148 周）。第 52 周时，接受甲氨蝶呤单药治疗或 RA-BEGIN 中巴瑞替尼 4mg+甲氨蝶呤治疗的初治患者转换为开放性标签巴瑞替尼 4mg 单药治疗；接受 RA-BEAM 中阿达木单抗（+甲氨蝶呤）治疗的 MTX 应答不足患者转换为 LTE 中开放性标签巴瑞替尼 4mg（+甲氨蝶呤）。第 24 周时，接受安慰剂（+甲氨蝶呤）的患者转换为巴瑞替尼 4mg（+甲氨蝶呤）。评估低疾病活动度（SDAI≤11）、临床缓解（SDAI≤3.3）和身体功能[健康评估问卷残疾指数（HAQ-DI）≤0.5]。使用无应答者插补法进行数据分析。
第 148 周时，初治患者中有多达 61%和 MTX 应答不足患者中有多达 59%接受巴瑞替尼治疗的患者达到 SDAI 低疾病活动度，初治患者中有多达 34%和 MTX 应答不足患者中有多达 24%接受巴瑞替尼治疗的患者达到 SDAI 缓解；初治患者中有多达 48%和 MTX 应答不足患者中有多达 38%接受巴瑞替尼治疗的患者达到 HAQ-DI≤0.5。在 148 周的治疗过程中，分别有 3.6%和 10.7%的 MTX 应答不足患者因缺乏疗效或因不良事件而停药，初治患者的停药率相似。
巴瑞替尼 4mg 治疗最长达 3 年，疗效良好且耐受性良好。
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