Preliminary Results of the FASM Study, an On-Going Italian Active Pharmacovigilance Project.

Autor: Maniscalco GT; Multiple Sclerosis Center, 'A. Cardarelli' Hospital, 80131 Naples, Italy.; Neurological Clinic and Stroke Unit, 'A. Cardarelli' Hospital, 80131 Naples, Italy., Brescia Morra V; MS Clinical Care and Research Centre, Department of Neuroscience, 'Federico II'' University, 80131 Naples, Italy., Florio C; Multiple Sclerosis Center, 'A. Cardarelli' Hospital, 80131 Naples, Italy.; Neurological Clinic and Stroke Unit, 'A. Cardarelli' Hospital, 80131 Naples, Italy., Lus G; Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, II Clinic of Neurology University of Campania 'Luigi Vanvitelli', 80131 Naples, Italy., Tedeschi G; I Clinica Neurologica e Neurofisiopatologia Azienda Ospedaliera Universitaria-Università della Campania 'Luigi Vanvitelli', 80138 Naples, Italy., Cianfrani M; AOU San Giovanni di Dio Ruggi D'aragona, 84131 Salerno, Italy., Docimo R; MS Center and Neurological Outpatient Service, 'San Giuseppe Moscati' Hospital, 81031 Aversa, Italy., Miniello S; Neurology and Stroke Unit, 'Sant'Anna e San Sebastiano' Hospital, 81100 Caserta, Italy., Romano F; Multiple Sclerosis Center and Neurological and Stroke Unit, CTO Hospital, AORN 'Ospedali dei Colli', 80131 Naples, Italy., Sinisi L; Neurological Unit and MS Center, San Paolo Hospital, ASL Napoli 1 Centro, 80125 Naples, Italy., Spitaleri DLA; UOC Neurologia-Centro Sclerosi Multipla-AORN San G. Moscati, 83100 Avellino, Italy., Longo G; Direzione Generale, 'A. Cardarelli' Hospital, 80131 Naples, Italy., Trama U; Regional Pharmaceutical Unit, Campania Region, 80143 Naples, Italy., Triassi M; Department of Public Health, 'Federico II'' University, 80138 Naples, Italy., Fasm Group, Scavone C; Department of Experimental Medicine, University of Campania 'Luigi Vanvitelli', 80138 Naples, Italy.; Regional Center of Pharmacovigilance and Pharmacoepidemiology of Campania Region, 80138 Naples, Italy., Capuano A; Department of Experimental Medicine, University of Campania 'Luigi Vanvitelli', 80138 Naples, Italy.; Regional Center of Pharmacovigilance and Pharmacoepidemiology of Campania Region, 80138 Naples, Italy.
Jazyk: angličtina
Zdroj: Pharmaceuticals (Basel, Switzerland) [Pharmaceuticals (Basel)] 2020 Dec 15; Vol. 13 (12). Date of Electronic Publication: 2020 Dec 15.
DOI: 10.3390/ph13120466
Abstrakt: Background and Aim: 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).
Results: 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.
Conclusion: 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.
Databáze: MEDLINE
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