Neurology Department, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain.
Neurology Department, Hospital Clínico San Carlos, Madrid, Spain.
PLoS One. 2021 Oct 13;16(10):e0258437. doi: 10.1371/journal.pone.0258437. eCollection 2021.
To describe the profile of patients with multiple sclerosis (MS) treated with fingolimod in Spain and to assess the effectiveness and safety of fingolimod after 4 years of inclusion in the Spanish Gilenya Registry.
An observational, retrospective/prospective, multicenter case registry, including all patients with relapsing-remitting MS (RRMS) starting treatment with fingolimod in 43 centers in Spain. Analyses were performed in the overall population and in subgroups according to prior disease-modifying therapy (DMT): glatiramer acetate/interferon beta-1 (BRACE), natalizumab, other treatment, or naïve.
Six hundred and sixty-six evaluable patients were included (91.1% previously treated with at least one DMT). The mean annualized relapse rate (ARR) prior to fingolimod was 1.12, and the mean EDSS at fingolimod initiation was 3.03. Fingolimod reduced the ARR by 71.4%, 75%, 75.5%, and 80.3%, after 1, 2, 3 and 4 years, respectively (p<0.001). This significant reduction in the ARR continued to be observed in all subgroups. After 4 years, the EDSS showed a minimal deterioration, with the EDSS scores from year 1 to year 4 remaining mostly stable. The percentage of patients without T1 Gd+ lesions progressively increased from 45.6% during the year prior to fingolimod initiation to 88.2% at year 4. The proportion of patients free from new/enlarged T2 lesions after 4 years of fingolimod treatment was 80.3%. This trend in both radiological measures was also observed in the subgroups. Adverse events (AEs) were experienced by up to 41.6% of patients (most commonly: lymphopenia [12.5%] and urinary tract infection [3.7%]). Most AEs were mild in severity, 3.6% of patients had serious AEs.
The patient profile was similar to other observational studies. The results obtained from the long-term use of fingolimod showed that it was effective, regardless of prior DMT, and it had adequate safety results, with a positive benefit-risk balance.
描述在西班牙接受芬戈莫德治疗的多发性硬化症（MS）患者的特征，并评估在纳入西班牙 Gilenya 登记处 4 年后芬戈莫德的有效性和安全性。
这是一项观察性、回顾性/前瞻性、多中心病例登记研究，纳入了西班牙 43 个中心开始接受芬戈莫德治疗的所有复发缓解型多发性硬化症（RRMS）患者。在总体人群和根据先前疾病修饰治疗（DMT）的亚组中进行了分析：那他珠单抗、干扰素β-1 或醋酸格拉替雷、其他治疗或初治。
共纳入 666 例可评估患者（91.1%之前至少接受过一种 DMT 治疗）。在接受芬戈莫德治疗之前，年平均复发率（ARR）为 1.12，在开始接受芬戈莫德治疗时的 EDSS 评分为 3.03。芬戈莫德分别在 1、2、3 和 4 年后将 ARR 降低了 71.4%、75%、75.5%和 80.3%（p<0.001）。在所有亚组中，这种ARR的显著降低仍在继续观察到。4 年后，EDSS 显示出最小程度的恶化，从第 1 年到第 4 年 EDSS 评分基本保持稳定。在开始接受芬戈莫德治疗前的 1 年内，无 T1 Gd+病变的患者比例逐渐增加至 45.6%，而在第 4 年达到 88.2%。在接受芬戈莫德治疗 4 年后，无新发/扩大 T2 病变的患者比例为 80.3%。这两种影像学指标的趋势在亚组中也观察到。多达 41.6%的患者出现不良事件（AE）（最常见的为：淋巴细胞减少[12.5%]和尿路感染[3.7%]）。大多数 AE 为轻度，3.6%的患者发生严重 AE。
患者特征与其他观察性研究相似。长期使用芬戈莫德的结果表明，无论先前的 DMT 如何，芬戈莫德均有效，且具有良好的安全性结果，具有积极的获益风险平衡。
