Teriflunomide for multiple sclerosis in real-world setting.
OBJECTIVE
Teriflunomide 14 mg is a once-daily oral disease-modifying treatment for relapsing-remitting multiple sclerosis. We examined adverse event (AE) profile and efficacy in real life.


METHODS
In this observational cohort study, we retrospectively examined 1521 blood samples and data of 102 patients followed for up to 28 months.


RESULTS
The number of female patients starting teriflunomide peaked in the fifth decade, 10 years later compared to male patients (P<.001), reflecting pregnancy concerns. Seventy-six percentages of patients shifted to teriflunomide from treatment with interferon-beta. Expanded disability status scale improved in 11% of patients (18.2±3.6 months follow-up) and remained constant in 67.5% (15±5.3 months follow-up). Of ten relapses, three occurred within 6 months after starting treatment. Seventeen patients (16.5%) discontinued teriflunomide: 53% because of AEs and 29% because of relapse. Levels of alanine aminotransferase (ALT) remained normal in 95.3% of the blood samples and remained below 1.5 times the upper limit of normal in 91% of the 4.7% abnormal samples. One-third of the patients had abnormal ALT values at least once. Haematological abnormalities were found in <4% of the blood samples, but at least one abnormal value was observed in up to 21% of the patients.


CONCLUSIONS
Efficacy and safety of teriflunomide in real-life setting support data obtained by the pivotal trials. Laboratory abnormalities are rare among the large number of samples, but patients may commonly have a single mild, abnormal value if frequently tested.
Department of Neurology, Odense University Hospital, Odense, Denmark.
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ML
Elkjaer
Department of Anesthesiology and Intensive Care, University of Pecs, Pecs, Hungary.
T
T
Molnar
Department of Neurology, Odense University Hospital, Odense, Denmark.|Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Z
http://orcid.org/0000-0001-9655-0450
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Illes
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D003437:Crotonates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006885:Hydroxybutyrates; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000097:blood / Q000188:drug therapy*; D009570:Nitriles; D014052:Toluidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D003437:Crotonates; D006885:Hydroxybutyrates; D009570:Nitriles; D014052:Toluidines; C527525:teriflunomide; D000410:Alanine Transaminase
adverse effects; demyelinating diseases efficacy; multiple sclerosis