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

Giorgia Teresa Maniscalco1,2, Vincenzo Brescia Morra3, Ciro Florio1,2

  • 1Multiple Sclerosis Center, "A. Cardarelli" Hospital, 80131 Naples, Italy.

Pharmaceuticals (Basel, Switzerland)
|December 18, 2020
PubMed
Abstract

Insights

Preliminary findings from the FASM study reveal adverse drug reactions (ADRs) associated with multiple sclerosis (MS) disease-modifying therapies (DMTs), primarily affecting women and linked to specific treatments like dimethyl fumarate and fingolimod.

Area of Science:

  • Pharmacovigilance
  • Neurology
  • Drug Safety

Background:

  • Multiple sclerosis (MS) treatments, known as disease-modifying therapies (DMTs), possess varied safety profiles.
  • Understanding these safety profiles is crucial for effective patient management.

Purpose of the Study:

  • To present preliminary findings from the FASM pharmacovigilance study.
  • To analyze adverse drug reactions (ADRs) associated with DMTs in MS patients.

Main Methods:

  • Collection of 272 Individual Case Safety Reports (ICSRs) from multiple sclerosis centers.
  • Analysis of ADRs, patient demographics, drug associations, and time to event.

Main Results:

  • ADRs were more frequent in adult women. No significant difference in ADR seriousness was observed.
  • Dimethyl fumarate, fingolimod, and IFN beta 1a were the most frequently suspected drugs, associated with hematological, gastrointestinal, and other disorders.
  • Median time to event varied among suspected drugs, with fingolimod showing the longest median time (1058 days).

Conclusions:

  • Preliminary results offer insights into DMT safety profiles in MS.
  • Further data will enhance understanding of DMTs' proper use and inform clinical recommendations for neurologists and patients.
Keywords:
FASM studyadverse drugs reactionsdisease-modifying therapiesmultiple sclerosispharmacovigilance projectsafety

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