Maniscalco Giorgia Teresa, Brescia Morra Vincenzo, Florio Ciro, Lus Giacomo, Tedeschi Gioacchino, Cianfrani Maddalena, Docimo Renato, Miniello Stefania, Romano Felice, Sinisi Leonardo, Spitaleri Daniele L A, Longo Giuseppe, Trama Ugo, Triassi Maria, Scavone Cristina, Capuano Annalisa
Multiple Sclerosis Center, "A. Cardarelli" Hospital, 80131 Naples, Italy.
Neurological Clinic and Stroke Unit, "A. Cardarelli" Hospital, 80131 Naples, Italy.
Pharmaceuticals (Basel). 2020 Dec 15;13(12):466. doi: 10.3390/ph13120466.
Disease-modifying therapies (DMTs) used in multiple sclerosis (MS) have distinct safety profiles. In this paper, we report preliminary results of an on-going pharmacovigilance project (the FASM study).
Neurologists working at involved multiple sclerosis centers collected 272 Individual Case Safety Reports (ICSRs). Adverse drug reactions (ADRs) mainly occurred in adult patients and in a higher percentage of women compared to men. No difference was found in ADRs distribution by seriousness. The outcome was reported as favorable in 61% of ICSRs. Out of 272 ICSRs, almost 53% reported dimethyl fumarate, fingolimod and IFN beta 1a as suspected. These medications were commonly associated to the occurrence of ADRs related hematological, gastrointestinal, general, infective or cancer disorders. The median time to event (days) was 177 for dimethyl fumarate, 1058 for fingolimod and 413 for IFN beta 1a. The median time to event for the remaining suspected drugs was 226.
We believe that our results, together with those that will be presented at the end of the study, may bring new knowledge concerning the safety profile of DMTs and their proper use. This will provide the opportunity to draw new recommendations both for neurologists and patients.
用于治疗多发性硬化症（MS）的疾病修正疗法（DMTs）具有不同的安全性特征。在本文中，我们报告了一项正在进行的药物警戒项目（FASM研究）的初步结果。
参与研究的多发性硬化症中心的神经科医生收集了272份个体病例安全报告（ICSRs）。药物不良反应（ADRs）主要发生在成年患者中，女性的发生率高于男性。ADRs在严重程度分布上未发现差异。在61%的ICSRs中报告结果为良好。在272份ICSRs中，近53%报告富马酸二甲酯、芬戈莫德和干扰素β-1a为可疑药物。这些药物通常与血液学、胃肠道、全身性、感染性或癌症相关疾病的ADRs发生有关。富马酸二甲酯的事件发生中位数时间（天）为177，芬戈莫德为1058，干扰素β-1a为413。其余可疑药物的事件发生中位数时间为226。
我们相信，我们的结果以及研究结束时将呈现的结果，可能会带来有关DMTs安全性特征及其合理使用的新知识。这将为神经科医生和患者提供制定新建议的机会。
