Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
National Center for Neurological Disorders, Shanghai, China.
Front Immunol. 2024 Mar 13;15:1343531. doi: 10.3389/fimmu.2024.1343531. eCollection 2024.
The aims of this study were to report the effectiveness and safety of teriflunomide in Chinese patients with relapsing-remitting multiple sclerosis (RRMS) and to explore the association of paramagnetic rim lesion (PRL) burden with patient outcome in the context of teriflunomide treatment and the impact of teriflunomide on PRL burden.
This is a prospective observational study. A total of 100 RRMS patients treated with teriflunomide ≥3 months were included in analyzing drug persistence and safety. Among them, 96 patients treated ≥6 months were included in assessing drug effectiveness in aspects of no evidence of disease activity (NEDA) 3. The number and total volume of PRL were calculated in 76 patients with baseline susceptibility-weighted imaging (SWI), and their association with NEDA3 failure during teriflunomide treatment was investigated.
Over a treatment period of 19.7 (3.1-51.7) months, teriflunomide reduced annualized relapse rate (ARR) from 1.1 ± 0.8 to 0.3 ± 0.5, and Expanded Disability Status Scale (EDSS) scores remained stable. At month 24, the NEDA3% and drug persistence rate were 43.8% and 65.1%, respectively. In patients with a baseline SWI, 81.6% had at least 1 PRL, and 42.1% had ≥4 PRLs. The total volume of PRL per patient was 0.3 (0.0-11.5) mL, accounting for 2.3% (0.0%-49.0%) of the total T2 lesion volume. Baseline PRL number ≥ 4 (OR = 4.24, = 0.009), younger onset age (OR = 0.94, = 0.039), and frequent relapses in initial 2 years of disease (OR = 13.40, = 0.026) were associated with NEDA3 failure. The PRL number and volume were not reduced ( = 0.343 and 0.051) after teriflunomide treatment for more than 24 months. No new safety concerns were identified in this study.
Teriflunomide is effective in reducing ARR in Chinese patients with RRMS. Patients with less PRL burden, less frequent relapses, and relatively older age are likely to benefit more from teriflunomide, indicating that PRL might be a valuable measurement to inform clinical treatment decision.
本研究旨在报告特立氟胺在中国复发缓解型多发性硬化（RRMS）患者中的疗效和安全性，并探讨特立氟胺治疗过程中顺磁环（PRL）负荷与患者结局的相关性，以及特立氟胺对 PRL 负荷的影响。
这是一项前瞻性观察性研究。共纳入 100 例接受特立氟胺治疗≥3 个月的 RRMS 患者，分析药物的持久性和安全性。其中，纳入 96 例接受特立氟胺治疗≥6 个月的患者，评估其在无疾病活动（NEDA）3 方面的药物疗效。对基线时接受磁敏感加权成像（SWI）检查的 76 例患者计算 PRL 的数量和总容积，并探讨其与特立氟胺治疗期间 NEDA3 失败的关系。
在 19.7（3.1-51.7）个月的治疗期间，特立氟胺将年化复发率（ARR）从 1.1±0.8 降至 0.3±0.5，扩展残疾状态量表（EDSS）评分保持稳定。在 24 个月时，NEDA3%和药物维持率分别为 43.8%和 65.1%。在基线时接受 SWI 检查的患者中，81.6%至少有 1 个 PRL，42.1%有≥4 个 PRL。每位患者的 PRL 总容积为 0.3（0.0-11.5）mL，占总 T2 病变容积的 2.3%（0.0%-49.0%）。基线时 PRL 数量≥4（OR=4.24， =0.009）、发病年龄较小（OR=0.94， =0.039）和疾病初始 2 年内频繁复发（OR=13.40， =0.026）与 NEDA3 失败相关。在接受特立氟胺治疗超过 24 个月后，PRL 数量和体积并未减少（ =0.343 和 0.051）。本研究未发现新的安全性问题。
特立氟胺在中国 RRMS 患者中可有效降低 ARR。PRL 负荷较低、复发频率较低和年龄相对较大的患者可能从特立氟胺中获益更多，表明 PRL 可能是一种有价值的治疗决策依据。
