Short-term laboratory and related safety outcomes for the multiple sclerosis oral disease-modifying therapies: an observational study.
Administration, Oral
Adult
Crotonates
/ administration & dosage
Databases, Factual
Dimethyl Fumarate
/ administration & dosage
Female
Fingolimod Hydrochloride
/ administration & dosage
Follow-Up Studies
Humans
Hydroxybutyrates
Immunosuppressive Agents
/ administration & dosage
Male
Middle Aged
Multiple Sclerosis
/ drug therapy
Nitriles
Prospective Studies
Toluidines
/ administration & dosage
Adverse events
dimethyl fumarate
fingolimod
multiple sclerosis
population-based study
teriflunomide
Journal
Expert opinion on drug safety
ISSN: 1744-764X
Titre abrégé: Expert Opin Drug Saf
Pays: England
ID NLM: 101163027
Informations de publication
Date de publication:
Apr 2021
Apr 2021
Historique:
pubmed:
22
12
2020
medline:
30
4
2021
entrez:
21
12
2020
Statut:
ppublish
Résumé
Real-world safety data for the oral multiple sclerosis (MS) disease-modifying therapies (DMTs), dimethyl fumarate (DMF), fingolimod, and teriflunomide are important. We examined laboratory test abnormalities and adverse health conditions in new users. Linked laboratory and administrative health data were accessed for all persons with MS (PwMS) filling their first oral DMT prescription in two Canadian provinces. PwMS were followed from first prescription fill until discontinuation, death, emigration or study end. Proportions of PwMS, and incidence rates (IR)/100 person-years, were calculated for ≥1 event of elevated alanine aminotransferase (ALT) (>the upper limit of normal [ULN]; all DMTs), liver toxicity (ALT>3xULN; fingolimod); lymphopenia and proteinuria (DMF), and cardiac arrhythmia, hypertension and pneumonia (all DMTs). Overall, 1,140 PwMS were followed for up to 2 years. The short-term, real-world incidences of abnormal laboratory results or adverse events were consistent with the pivotal clinical trial findings. Longer-term safety data are still needed.
Sections du résumé
BACKGROUND
BACKGROUND
Real-world safety data for the oral multiple sclerosis (MS) disease-modifying therapies (DMTs), dimethyl fumarate (DMF), fingolimod, and teriflunomide are important. We examined laboratory test abnormalities and adverse health conditions in new users.
METHODS
METHODS
Linked laboratory and administrative health data were accessed for all persons with MS (PwMS) filling their first oral DMT prescription in two Canadian provinces. PwMS were followed from first prescription fill until discontinuation, death, emigration or study end. Proportions of PwMS, and incidence rates (IR)/100 person-years, were calculated for ≥1 event of elevated alanine aminotransferase (ALT) (>the upper limit of normal [ULN]; all DMTs), liver toxicity (ALT>3xULN; fingolimod); lymphopenia and proteinuria (DMF), and cardiac arrhythmia, hypertension and pneumonia (all DMTs).
RESULTS
RESULTS
Overall, 1,140 PwMS were followed for up to 2 years.
CONCLUSIONS
CONCLUSIONS
The short-term, real-world incidences of abnormal laboratory results or adverse events were consistent with the pivotal clinical trial findings. Longer-term safety data are still needed.
Identifiants
pubmed: 33342303
doi: 10.1080/14740338.2021.1867536
doi:
Substances chimiques
Crotonates
0
Hydroxybutyrates
0
Immunosuppressive Agents
0
Nitriles
0
Toluidines
0
teriflunomide
1C058IKG3B
Dimethyl Fumarate
FO2303MNI2
Fingolimod Hydrochloride
G926EC510T
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM