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Published on: December 9, 2015
Teriflunomide for multiple sclerosis in real-world setting
M L Elkjaer1, T Molnar2, Z Illes1,3
1Department of Neurology, Odense University Hospital, Odense, Denmark.
Objectives:
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.
Materials And 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.
Insights
This study evaluated teriflunomide (a multiple sclerosis treatment) in real-world use. It found comparable safety and efficacy to clinical trials, with rare lab abnormalities.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Teriflunomide is an oral disease-modifying therapy for relapsing-remitting multiple sclerosis.
- Real-world data on teriflunomide's safety and efficacy are valuable for clinical practice.
Purpose of the Study:
- To assess the adverse event (AE) profile and efficacy of teriflunomide in a real-life setting.
- To compare real-world findings with data from pivotal clinical trials.
Main Methods:
- Observational cohort study involving 102 patients with relapsing-remitting multiple sclerosis.
- Retrospective analysis of 1521 blood samples and patient data over a follow-up period of up to 28 months.
Main Results:
- Teriflunomide showed comparable efficacy to pivotal trials, with 11% improved and 67.5% stable Expanded Disability Status Scale scores.
- Seventy-six percent of patients switched from interferon-beta; 16.5% discontinued teriflunomide, primarily due to AEs (53%) or relapse (29%).
- Elevated alanine aminotransferase (ALT) levels were uncommon (abnormal in <4.7% of samples), though one-third of patients had at least one mild abnormality; hematological abnormalities were also infrequent.
Conclusions:
- Real-world efficacy and safety of teriflunomide align with pivotal trial results.
- Laboratory abnormalities are rare, but mild, transient elevations in ALT may occur with frequent testing.
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