Division of Rheumatology, Department of Medicine, Solna, and Center for Molecular Medicine, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.
Division of Rheumatology, Jewish General Hospital, Montreal, Quebec, Canada.
Rheumatology (Oxford). 2019 Jul 1;58(7):1214-1220. doi: 10.1093/rheumatology/key450.
Post-hoc analyses of the Rituximab in Myositis trial indicate that specific autoantibodies profiles may influence treatment response. We compared the efficacy and safety of rituximab in anti-synthetase antibody (ARS-ab) positive and negative patients.
Adult idiopathic inflammatory myopathy (IIM) subjects in the Swedish Rheumatology Quality Register who received ⩾ 1 cycle of rituximab were enrolled. Efficacy assessment was based on the International Myositis Assessment and Clinical Studies (IMACS) core set measures and the 2016 ACR/EULAR definition of improvement for PM and DM. Safety assessment included drug-related adverse event and death during study period. Comparisons were done within and between the ARS-ab defined groups before and after first and last cycles. Associations between selected clinical features and improvement after one rituximab cycle were assessed using logistic regression.
Sixty-five subjects were included and 43 had a follow-up visit within 5-10 months. Seventy-eight percent of ARS-ab positive subjects had moderate/major ACR/EULAR improvement after one cycle compared with 50% in the ARS-ab negative group. After several cycles, 79% of the ARS-ab positive and 67% of the ARS-ab negative patients achieved moderate/major improvement. A significant glucocorticoid-sparing effect was only observed in the ARS-ab positive group (P = 0.001). The most frequent adverse events were infections. One ARS-ab positive and two ARS-ab negative patients died during follow-up period.
Irrespectively of their autoantibody status, a majority of subjects treated with several rituximab cycles had moderate/major improvement. In addition, ARS-ab positive subjects experienced a significant glucocorticoid-sparing effect.
Rituximab in Myositis 试验的事后分析表明，特定的自身抗体谱可能影响治疗反应。我们比较了抗合成酶抗体（ARS-ab）阳性和阴性患者接受利妥昔单抗治疗的疗效和安全性。
在瑞典风湿病质量登记处接受 ⩾ 1 个周期利妥昔单抗治疗的成人特发性炎性肌病（IIM）患者被纳入研究。疗效评估基于国际肌炎评估和临床研究（IMACS）核心组测量和 2016 年 ACR/EULAR 对 PM 和 DM 的改善定义。安全性评估包括研究期间与药物相关的不良事件和死亡。在 ARS-ab 定义的组内和组间比较了第一和最后一个周期前后的情况。使用逻辑回归评估选定的临床特征与一个利妥昔单抗周期后的改善之间的关联。
共纳入 65 例患者，43 例在 5-10 个月内进行了随访。78%的 ARS-ab 阳性患者在一个周期后达到中度/主要 ACR/EULAR 改善，而 ARS-ab 阴性组为 50%。经过几个周期，79%的 ARS-ab 阳性和 67%的 ARS-ab 阴性患者达到中度/主要改善。仅在 ARS-ab 阳性组观察到显著的糖皮质激素节省效应（P = 0.001）。最常见的不良事件是感染。在随访期间，1 例 ARS-ab 阳性和 2 例 ARS-ab 阴性患者死亡。
无论其自身抗体状态如何，接受几个利妥昔单抗周期治疗的大多数患者都有中度/主要改善。此外，ARS-ab 阳性患者经历了显著的糖皮质激素节省效应。
