由于无应答和/或研究设计而从阿达木单抗转换为巴瑞替尼的患者的临床结局：类风湿关节炎患者的 III 期数据。
Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis.
机构信息
The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan
Dept of Rheumatology, Sorbonne Universite,Pierre Louis Institute of Epidemiology and Public Health, Pépites team; APHP, GH Pitie Salpetriere, Paris, France.
出版信息
Ann Rheum Dis. 2019 Jul;78(7):890-898. doi: 10.1136/annrheumdis-2018-214529. Epub 2019 Apr 30.
OBJECTIVE
To evaluate clinical outcomes in patients who changed treatment from adalimumab to baricitinib, an oral Janus kinase (JAK)1/JAK2 inhibitor, during a phase III programme.
METHODS
In phase III RA-BEAM, patients were randomised 3:3:2 to placebo, baricitinib 4 mg once daily, or adalimumab 40 mg biweekly. At week 16 or subsequent visits, non-responders were rescued to open-label baricitinib 4 mg. At week 52, patients could enter a long-term extension (LTE) and continue on baricitinib or switch from adalimumab to baricitinib 4 mg with no adalimumab washout period. Percentage of patients achieving low disease activity and remission were assessed, along with physical function, patient's assessment of pain, and safety.
RESULTS
Thirty-five (7%) baricitinib-treated and 40 (12%) adalimumab-treated patients were rescued to baricitinib in RA-BEAM; 78% (381/487) of baricitinib-treated and 72% (238/330) of adalimumab-treated patients who were not rescued in RA-BEAM, entered the LTE and continued/were switched to baricitinib. In both baricitinib-rescued and adalimumab-rescued patients, there were significant improvements in all measures up to 12 weeks after rescue compared with the time of rescue. Patients who switched from adalimumab to baricitinib showed improvements in disease control through 12 weeks in the LTE. Exposure-adjusted incidence rates for treatment-emergent adverse events (TEAEs) and infections, including serious events, were similar for patients who switched from adalimumab to baricitinib and those who continued on baricitinib.
CONCLUSIONS
Switching from adalimumab to baricitinib (without adalimumab washout) was associated with improvements in disease control, physical function and pain during the initial 12 weeks postswitch, without an increase in TEAEs, serious adverse events or infections.
TRIAL REGISTRATION NUMBERS
NCT01710358, NCT01885078.
目的
评估在 III 期 RA-BEAM 项目中，从阿达木单抗转换为巴瑞替尼（一种口服 Janus 激酶（JAK）1/JAK2 抑制剂）治疗的患者的临床结局。
方法
在 III 期 RA-BEAM 中，患者按 3:3:2 的比例随机分配至安慰剂、巴瑞替尼 4mg 每日一次或阿达木单抗 40mg 每两周一次。在第 16 周或后续访视时，无应答者转为开放标签的巴瑞替尼 4mg。在第 52 周时，患者可进入长期扩展（LTE）期，并继续使用巴瑞替尼或无阿达木单抗洗脱期从阿达木单抗转换为巴瑞替尼 4mg。评估了达到低疾病活动和缓解的患者比例，以及身体功能、患者对疼痛的评估和安全性。
结果
在 RA-BEAM 中，有 35 名（7%）接受巴瑞替尼治疗的患者和 40 名（12%）接受阿达木单抗治疗的患者转为巴瑞替尼治疗；在 RA-BEAM 中未被解救的 78%（381/487）的巴瑞替尼治疗患者和 72%（238/330）的阿达木单抗治疗患者进入 LTE 期并继续/转为巴瑞替尼治疗。在巴瑞替尼解救和阿达木单抗解救的患者中，与解救时相比，在解救后 12 周时所有指标均有显著改善。在 LTE 期，从阿达木单抗转换为巴瑞替尼的患者在疾病控制方面的改善可持续至 12 周。从阿达木单抗转换为巴瑞替尼的患者和继续接受巴瑞替尼治疗的患者的治疗中出现的不良事件（TEAEs）和感染（包括严重事件）的发生率相似。
结论
从阿达木单抗转换为巴瑞替尼（无阿达木单抗洗脱期）与初始 12 周后疾病控制、身体功能和疼痛的改善相关，而 TEAEs、严重不良事件或感染无增加。
临床试验注册号
NCT01710358，NCT01885078。
Zotero 插件