Center of Clinical Neuroscience (T.Z.), Neurological University Clinic Carl Gustav Carus, University of Technology, Dresden; NeuroPoint Patient Academy and Neurological Practice (M.L.), Ulm; Department of Neurology (B.T.), Center of Neuroimmunology, Philipps-University, Marburg; Bonn Neurological Practice (S.S.); Neurological Practice (H.A.), Munich; Department of Neurology (L.K.), University Hospital Münster, Münster; Centre for Multiple Sclerosis (J.H.), Jewish Hospital Berlin; Kassel and Vellmar Neurology Practice (C.L.), Vellmar, Germany; Oxford PharmaGenesis (C.A-M.C.); Oxford PharmaGenesis (J.A.F.), United Kingdom; and Novartis Pharma GmbH (C.C.), Nuremberg, Germany.
Neurol Neuroimmunol Neuroinflamm. 2019 Mar 7;6(3):e548. doi: 10.1212/NXI.0000000000000548. eCollection 2019 May.
To assess the long-term real-world benefit-risk profile of fingolimod in patients with relapsing MS in Germany.
This analysis used data from the noninterventional real-world study, Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA), to assess prospectively the persistence, effectiveness, and safety of fingolimod over 36 months (±90 days) in Germany. For inclusion in the effectiveness analysis (n = 2,537), patients were required to have received fingolimod for the first time in PANGAEA, to have at least 12 months of data, and to have completed each 12-month follow-up period. For the safety analysis (n = 3,266), patients were additionally allowed to have received fingolimod before enrollment.
At baseline, 94.7% of patients in the effectiveness analysis had received a previous disease-modifying therapy. After 36 months, 70.4% of patients were still receiving fingolimod. Over this period, annualized relapse rates decreased to 0.265 (95% CI: 0.244-0.286) from 1.79 (95% CI: 1.75-1.83), and mean Expanded Disability Status Scale scores remained stable (mean change from baseline: +0.049 [95% CI: -0.015 to +0.114]). In total, 16% of patients had 6-month confirmed disability improvement, 12.5% had 6-month confirmed disability worsening, and 52.4% were free from relapses and 6-month confirmed disability worsening. Adverse events (AEs) and serious AEs were experienced by up to 23.4% and 3.9% of patients, respectively, during any of the 12-month follow-up periods. The frequency and nature of AEs were in line with previous findings.
Using systematically collected data from PANGAEA, this analysis demonstrates the sustained effectiveness, high persistence, and manageable safety profile of fingolimod over 36 months.
评估在德国复发型多发性硬化症患者中使用芬戈莫德的长期真实世界获益-风险概况。
本分析使用非干预性真实世界研究——Post-Authorization Non-interventional German sAfety study of GilEnyA（PANGAEA）的数据，前瞻性评估芬戈莫德在德国的 36 个月（±90 天）的持续性、疗效和安全性。为了纳入疗效分析（n=2537），患者必须在 PANGAEA 中首次接受芬戈莫德治疗，至少有 12 个月的数据，并且完成了每 12 个月的随访期。对于安全性分析（n=3266），允许患者在入组前接受芬戈莫德治疗。
在基线时，疗效分析中的 94.7%的患者接受了之前的疾病修正治疗。36 个月后，70.4%的患者仍在接受芬戈莫德治疗。在此期间，年复发率从 1.79（95%CI：1.75-1.83）下降至 0.265（95%CI：0.244-0.286），扩展残疾状态量表评分保持稳定（与基线相比的平均变化：+0.049 [95%CI：-0.015 至 +0.114]）。总共有 16%的患者有 6 个月确认的残疾改善，12.5%的患者有 6 个月确认的残疾恶化，52.4%的患者无复发和 6 个月确认的残疾恶化。在任何 12 个月的随访期间，分别有 23.4%和 3.9%的患者经历了不良事件（AE）和严重不良事件（SAE）。AE 的频率和性质与之前的发现一致。
使用 PANGAEA 系统收集的数据，本分析证明了芬戈莫德在 36 个月内的持续疗效、高持续性和可管理的安全性。
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