Teriflunomide for multiple sclerosis in real-world setting

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

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.

Original languageEnglish
JournalActa Neurologica Scandinavica
Volume136
Issue number5
Pages (from-to)447–453
ISSN0001-6314
DOIs
Publication statusPublished - 2017

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Alanine Transaminase
Mouth Diseases
Relapsing-Remitting Multiple Sclerosis
Cohort Studies
Safety

Keywords

  • Journal Article

Cite this

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title = "Teriflunomide for multiple sclerosis in real-world setting",
abstract = "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.",
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author = "Elkj{\ae}r, {Maria Louise} and T Molnar and Z Illes",
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year = "2017",
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Teriflunomide for multiple sclerosis in real-world setting. / Elkjær, Maria Louise; Molnar, T; Illes, Z.

In: Acta Neurologica Scandinavica, Vol. 136, No. 5, 2017, p. 447–453.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Teriflunomide for multiple sclerosis in real-world setting

AU - Elkjær, Maria Louise

AU - Molnar, T

AU - Illes, Z

N1 - © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

PY - 2017

Y1 - 2017

N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.1111/ane.12755

DO - 10.1111/ane.12755

M3 - Journal article

C2 - 28321835

VL - 136

SP - 447

EP - 453

JO - Acta Neurologica Scandinavica

JF - Acta Neurologica Scandinavica

SN - 0001-6314

IS - 5

ER -