Imai Yuki, Takanashi Satoshi, Kaneko Yuko
Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan.
Rheumatol Int. 2025 Aug 26;45(9):207. doi: 10.1007/s00296-025-05941-0.
This study aimed to evaluate the effectiveness and safety of tocilizumab in polymyalgia rheumatica (PMR) in the real world.
All consecutive patients diagnosed with PMR who visited Keio University Hospital between May 2012 and October 2022 were retrospectively reviewed. Patients were divided into three groups: the tocilizumab group, the immunosuppressant group without biological agents, and the glucocorticoid monotherapy group. We collected clinical data including relapse, glucocorticoid doses, and adverse events during follow-up.
A total of 125 patients with PMR was included in the analyses, with a mean age of 73.6 years and 83 (66.4%) female. Among them, 52 (41.6%) were in the tocilizumab group, 23 (18.4%) in the immunosuppressant group, and 50 (40.0%) in the glucocorticoid group. The glucocorticoid group showed the lowest serum C-reactive protein level at diagnosis (P = 0.046). Tocilizumab extended the time to relapse, even when given to patients with a relatively refractory disease course, although relapse assessment was not independent of C-reactive protein levels. The time to glucocorticoid discontinuation was the shortest in the tocilizumab group (P < 0.001 for induction or re-induction, P = 0.08 for maintenance). Tocilizumab use, methotrexate use and the number of relapses were identified as significant predictors of achieving glucocorticoid-free status. Adverse events were not significantly different between the three groups.
Tocilizumab effectively reduced relapse rates and demonstrated glucocorticoid-sparing effects in patients with refractory PMR in the real world, with no significant safety issues. These results further support the existing evidence that tocilizumab may be a promising treatment option in real-world settings.
本研究旨在评估托珠单抗在现实世界中治疗风湿性多肌痛（PMR）的有效性和安全性。
回顾性分析2012年5月至2022年10月期间在庆应义塾大学医院就诊的所有连续诊断为PMR的患者。患者分为三组：托珠单抗组、无生物制剂的免疫抑制剂组和糖皮质激素单药治疗组。我们收集了随访期间的临床数据，包括复发情况、糖皮质激素剂量和不良事件。
共有125例PMR患者纳入分析，平均年龄73.6岁，女性83例（66.4%）。其中，托珠单抗组52例（41.6%），免疫抑制剂组23例（18.4%），糖皮质激素组50例（40.0%）。糖皮质激素组在诊断时血清C反应蛋白水平最低（P = 0.046）。托珠单抗延长了复发时间，即使给予病程相对难治的患者，尽管复发评估并非独立于C反应蛋白水平。托珠单抗组糖皮质激素停用时间最短（诱导或再诱导时P < 0.001，维持时P = 0.08）。使用托珠单抗、使用甲氨蝶呤和复发次数被确定为实现无糖皮质激素状态的显著预测因素。三组不良事件无显著差异。
在现实世界中，托珠单抗有效降低了难治性PMR患者的复发率，并显示出糖皮质激素节省效应，且无显著安全问题。这些结果进一步支持了现有证据，即托珠单抗在现实世界环境中可能是一种有前景的治疗选择。
