Preliminary Results of the FASM Study, an On-Going Italian Active Pharmacovigilance Project.
FASM study
adverse drugs reactions
disease-modifying therapies
multiple sclerosis
pharmacovigilance project
safety
Journal
Pharmaceuticals (Basel, Switzerland)
ISSN: 1424-8247
Titre abrégé: Pharmaceuticals (Basel)
Pays: Switzerland
ID NLM: 101238453
Informations de publication
Date de publication:
15 Dec 2020
15 Dec 2020
Historique:
received:
19
10
2020
revised:
09
12
2020
accepted:
12
12
2020
entrez:
18
12
2020
pubmed:
19
12
2020
medline:
19
12
2020
Statut:
epublish
Résumé
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.
Sections du résumé
BACKGROUND AND AIM
OBJECTIVE
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
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
CONCLUSIONS
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.
Identifiants
pubmed: 33333889
pii: ph13120466
doi: 10.3390/ph13120466
pmc: PMC7765255
pii:
doi:
Types de publication
Journal Article
Langues
eng
Subventions
Organisme : Agenzia Italiana del Farmaco, Ministero della Salute
ID : Fondi di Farmacovigilanza 2010-2011, art.4, comma 2 della Convenzione stipulata il 18/03/2016 tra AIFA e la Regione Campania, per Progetto Regionale di Farmacovigilanza dal titolo "Progetto per il monitoraggio e aumento delle segnalazioni di reazioni avve
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