Division of Neurology, Department of Clinical Neurosciences, Lausanne University Hospital and University of Lausanne, Rue du Bugnon 46, 1011 Lausanne, Switzerland; Laboratories of Neuroimmunology, Neuroscience Research Center , Lausanne University, Epalinges, Switzerland.
Division of Neurology, Department of Clinical Neurosciences, Lausanne University Hospital and University of Lausanne, Rue du Bugnon 46, 1011 Lausanne, Switzerland.
Rev Neurol (Paris). 2021 Oct;177(8):935-940. doi: 10.1016/j.neurol.2020.11.009. Epub 2021 Feb 23.
In countries where fingolimod is available as first-line therapy without restrictions, we have an opportunity to observe long-term efficacy profile of this drug in treatment-naive patients according to their initial disease activity.
We retrospectively analysed the data of RRMS patients treated with FTY, focusing on 2 groups: 17 highly active patients (HA) defined as follows: ≥2 relapses in the year before treatment initiation and either≥1 Gd-enhancing T1 lesion or a significant increase in T2 lesion load from a baseline MRI; and 37 "not highly active" (NHA). We reviewed treatment efficacy (defined as NEDA-3), reasons for discontinuation and treatment tolerance in both groups.
Mean follow-up duration was 48.2 months, SD 18.4. Fingolimod efficiently reduced relapses (NHA 90.3% reduction, P<0.001, HA 84.9%, P<0.001), and new Gd enhancing lesions (NHA 85.4% reduction, P=0.019, HA 92.3%, P=0.043). The proportion of patients reaching NEDA-3 status was higher in the NHA group (NHA: 80% at 2 years and 66% at 4 years, HA: 58% at 2 years and 38% at 4 years, P=0.042). Fingolimod was discontinued in 20 cases, mainly because of lack of efficacy (n=15).
FTY is efficient in reducing relapses and new Gd enhancing lesions in both HA and NHA patients although the probability of achieving NEDA-3 over time is higher in early-treated treatment-naive NHA patients.
在没有限制的情况下，将芬戈莫德作为一线治疗药物的国家，我们有机会根据患者的初始疾病活动度观察该药在未经治疗的初治患者中的长期疗效概况。
我们回顾性分析了接受 FTY 治疗的 RRMS 患者的数据，重点关注 2 组患者：17 例高度活跃患者（HA），定义如下：在治疗开始前的 1 年内有≥2 次复发，或基线 MRI 上有≥1 个钆增强 T1 病变或 T2 病变负荷明显增加；和 37 例“非高度活跃”（NHA）患者。我们在这两组患者中评估了治疗效果（定义为 NEDA-3）、停药原因和治疗耐受性。
平均随访时间为 48.2 个月，标准差为 18.4。芬戈莫德能有效减少复发（NHA 减少 90.3%，P<0.001，HA 减少 84.9%，P<0.001）和新的钆增强病变（NHA 减少 85.4%，P=0.019，HA 减少 92.3%，P=0.043）。NHA 组达到 NEDA-3 状态的患者比例较高（NHA：2 年时为 80%，4 年时为 66%，HA：2 年时为 58%，4 年时为 38%，P=0.042）。芬戈莫德因疗效不佳而停药的有 20 例（n=15）。
FTY 可有效减少 HA 和 NHA 患者的复发和新的钆增强病变，尽管早期治疗的初治 NHA 患者随着时间的推移达到 NEDA-3 的可能性更高。
