University of Texas Southwestern Medical Center, Dallas.
Keio University School of Medicine, Tokyo, Japan.
Arthritis Care Res (Hoboken). 2020 Aug;72(8):1112-1121. doi: 10.1002/acr.24007.
To evaluate the long-term efficacy and safety of maintaining baricitinib monotherapy in patients with active rheumatoid arthritis (RA) originally treated with baricitinib monotherapy or switched from methotrexate (MTX) or the combination of baricitinib plus MTX to baricitinib monotherapy.
This is a post hoc analysis of patients from the RA-BEGIN study who entered a long-term extension, RA-BEYOND, and were assessed for up to 24 weeks. In RA-BEGIN, MTX-naive patients with early active RA were randomized to MTX monotherapy, baricitinib 4 mg monotherapy, or baricitinib 4 mg plus MTX. At week 52, all patients entering RA-BEYOND received baricitinib 4 mg monotherapy. MTX could be prescribed during RA-BEYOND at the investigator's discretion.
Patients in RA-BEYOND who were not rescued in RA-BEGIN (n = 423) were evaluated. Of these, 47% continued baricitinib monotherapy and 53% added MTX, with similar proportions from the 3 original arms. Patients with lower disease activity at the RA-BEYOND baseline generally continued to do well with baricitinib monotherapy as assessed by the Simplified Disease Activity Index, the Clinical Disease Activity Index, and the Health Assessment Questionnaire disability index scores. Patients prescribed MTX had higher disease activity at the RA-BEYOND baseline and had improved disease activity after the addition of MTX. Safety outcomes were similar across treatment groups.
Many patients responded well to continued baricitinib monotherapy or to switching to baricitinib monotherapy from MTX monotherapy or baricitinib plus MTX, showing sustained or improved disease control. The groups of patients who had less disease control on their original therapies showed sustained or improved disease control with the addition of MTX to baricitinib.
评估最初接受巴利昔替尼单药治疗或从甲氨蝶呤（MTX）或巴利昔替尼联合 MTX 转换为巴利昔替尼单药治疗的活动性类风湿关节炎（RA）患者继续接受巴利昔替尼单药治疗的长期疗效和安全性。
这是 RA-BEGIN 研究中患者的事后分析，他们进入了长期扩展研究 RA-BEYOND，并在长达 24 周的时间内进行评估。在 RA-BEGIN 中，初治早期活动性 RA 的 MTX 初治患者被随机分配至 MTX 单药治疗、巴利昔替尼 4mg 单药治疗或巴利昔替尼 4mg 联合 MTX 治疗。在第 52 周，所有进入 RA-BEYOND 的患者均接受巴利昔替尼 4mg 单药治疗。RA-BEYOND 期间可由研究者酌情开具 MTX 处方。
评估了未在 RA-BEGIN 中缓解的 RA-BEYOND 患者（n=423）。其中，47%继续接受巴利昔替尼单药治疗，53%加用 MTX，3 个原始治疗组的比例相似。RA-BEYOND 基线时疾病活动度较低的患者通常继续接受巴利昔替尼单药治疗，简化疾病活动度指数、临床疾病活动度指数和健康评估问卷残疾指数评分评估结果良好。加用 MTX 的患者 RA-BEYOND 基线时疾病活动度较高，加用 MTX 后疾病活动度得到改善。各组间安全性结局相似。
许多患者对继续接受巴利昔替尼单药治疗或从 MTX 单药治疗或巴利昔替尼联合 MTX 转换为巴利昔替尼单药治疗反应良好，表现出持续或改善的疾病控制。在原始治疗中疾病控制较差的患者，加用 MTX 可使疾病得到持续或改善控制。
