Comparative effectiveness of teriflunomide and dimethyl fumarate

A nationwide cohort study

Mathias Due Buron, Thor Ameri Chalmer, Finn Sellebjerg, Jette Frederiksen, Monika Katarzyna Góra, Zsolt Illes, Matthias Kant, Zsolt Mezei, Thor Petersen, Peter Vestergaard Rasmussen, Homayoun Roshanisefat, Houry Hassanpour-Kalam-Roudy, Tobias Sejbæk, Anna Tsakiri, Arkadiusz Weglewski, Per Soelberg Sorensen, Melinda Magyari

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

OBJECTIVE: To compare on-treatment efficacy and discontinuation outcomes in teriflunomide (TFL) and dimethyl fumarate (DMF) in the treatment of relapsing-remitting multiple sclerosis (RRMS) in a real-world setting.

METHODS: We identified all patients starting TFL or DMF from the Danish Multiple Sclerosis Registry and compared on-treatment efficacy outcomes between DMF using TFL, adjusted for clinical baseline variables and propensity score-based methods.

RESULTS: We included 2,236 patients in the study: 1,469 patients on TFL and 767 on DMF. Annualized relapse rates (ARRs) in TFL and DMF were 0.16 (95% confidence interval [CI] 0.13-0.20) and 0.09 (95% CI 0.07-0.12), respectively. Relapse rate ratio for DMF/TFL was 0.58 (95% CI 0.46-0.73, p < 0.001). DMF had a higher relapse-free survival proportion at 48 months of follow-up (p < 0.05). We observed no difference in Expanded Disability Status Scale score worsening. Discontinuations due to disease breakthrough were 10.2% (95% CI 7.6%-12.8%) and 22.1% (95% CI 19.2%-25.0%) for DMF and TFL, respectively. A subgroup analysis of ARRs in 708 patients with available baseline MRI T2 lesion amount reported similar results after adjustment.

CONCLUSION: We found lower ARR, higher relapse-free survival, and lower incidence of discontinuation due to disease breakthrough on treatment with DMF compared with TFL.

CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with RRMS, DMF is more effective in preventing relapses and has lower discontinuation due to disease breakthrough compared with TFL.

OriginalsprogEngelsk
TidsskriftNeurology
Vol/bind92
Udgave nummer16
Sider (fra-til)e1811-e1820
ISSN0028-3878
DOI
StatusUdgivet - 1. apr. 2019

Fingeraftryk

Cohort Studies
Confidence Intervals
Relapsing-Remitting Multiple Sclerosis
Dimethyl Fumarate
Propensity Score
Registries
Incidence

Citer dette

Buron, M. D., Chalmer, T. A., Sellebjerg, F., Frederiksen, J., Góra, M. K., Illes, Z., ... Magyari, M. (2019). Comparative effectiveness of teriflunomide and dimethyl fumarate: A nationwide cohort study. Neurology, 92(16), e1811-e1820. https://doi.org/10.1212/WNL.0000000000007314
Buron, Mathias Due ; Chalmer, Thor Ameri ; Sellebjerg, Finn ; Frederiksen, Jette ; Góra, Monika Katarzyna ; Illes, Zsolt ; Kant, Matthias ; Mezei, Zsolt ; Petersen, Thor ; Rasmussen, Peter Vestergaard ; Roshanisefat, Homayoun ; Hassanpour-Kalam-Roudy, Houry ; Sejbæk, Tobias ; Tsakiri, Anna ; Weglewski, Arkadiusz ; Sorensen, Per Soelberg ; Magyari, Melinda. / Comparative effectiveness of teriflunomide and dimethyl fumarate : A nationwide cohort study. I: Neurology. 2019 ; Bind 92, Nr. 16. s. e1811-e1820.
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title = "Comparative effectiveness of teriflunomide and dimethyl fumarate: A nationwide cohort study",
abstract = "OBJECTIVE: To compare on-treatment efficacy and discontinuation outcomes in teriflunomide (TFL) and dimethyl fumarate (DMF) in the treatment of relapsing-remitting multiple sclerosis (RRMS) in a real-world setting.METHODS: We identified all patients starting TFL or DMF from the Danish Multiple Sclerosis Registry and compared on-treatment efficacy outcomes between DMF using TFL, adjusted for clinical baseline variables and propensity score-based methods.RESULTS: We included 2,236 patients in the study: 1,469 patients on TFL and 767 on DMF. Annualized relapse rates (ARRs) in TFL and DMF were 0.16 (95{\%} confidence interval [CI] 0.13-0.20) and 0.09 (95{\%} CI 0.07-0.12), respectively. Relapse rate ratio for DMF/TFL was 0.58 (95{\%} CI 0.46-0.73, p < 0.001). DMF had a higher relapse-free survival proportion at 48 months of follow-up (p < 0.05). We observed no difference in Expanded Disability Status Scale score worsening. Discontinuations due to disease breakthrough were 10.2{\%} (95{\%} CI 7.6{\%}-12.8{\%}) and 22.1{\%} (95{\%} CI 19.2{\%}-25.0{\%}) for DMF and TFL, respectively. A subgroup analysis of ARRs in 708 patients with available baseline MRI T2 lesion amount reported similar results after adjustment.CONCLUSION: We found lower ARR, higher relapse-free survival, and lower incidence of discontinuation due to disease breakthrough on treatment with DMF compared with TFL.CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with RRMS, DMF is more effective in preventing relapses and has lower discontinuation due to disease breakthrough compared with TFL.",
author = "Buron, {Mathias Due} and Chalmer, {Thor Ameri} and Finn Sellebjerg and Jette Frederiksen and G{\'o}ra, {Monika Katarzyna} and Zsolt Illes and Matthias Kant and Zsolt Mezei and Thor Petersen and Rasmussen, {Peter Vestergaard} and Homayoun Roshanisefat and Houry Hassanpour-Kalam-Roudy and Tobias Sejb{\ae}k and Anna Tsakiri and Arkadiusz Weglewski and Sorensen, {Per Soelberg} and Melinda Magyari",
note = "{\circledC} 2019 American Academy of Neurology.",
year = "2019",
month = "4",
day = "1",
doi = "10.1212/WNL.0000000000007314",
language = "English",
volume = "92",
pages = "e1811--e1820",
journal = "Neurology",
issn = "0028-3878",
publisher = "Lippincott Williams & Wilkins",
number = "16",

}

Buron, MD, Chalmer, TA, Sellebjerg, F, Frederiksen, J, Góra, MK, Illes, Z, Kant, M, Mezei, Z, Petersen, T, Rasmussen, PV, Roshanisefat, H, Hassanpour-Kalam-Roudy, H, Sejbæk, T, Tsakiri, A, Weglewski, A, Sorensen, PS & Magyari, M 2019, 'Comparative effectiveness of teriflunomide and dimethyl fumarate: A nationwide cohort study', Neurology, bind 92, nr. 16, s. e1811-e1820. https://doi.org/10.1212/WNL.0000000000007314

Comparative effectiveness of teriflunomide and dimethyl fumarate : A nationwide cohort study. / Buron, Mathias Due; Chalmer, Thor Ameri; Sellebjerg, Finn; Frederiksen, Jette; Góra, Monika Katarzyna; Illes, Zsolt; Kant, Matthias; Mezei, Zsolt; Petersen, Thor; Rasmussen, Peter Vestergaard; Roshanisefat, Homayoun; Hassanpour-Kalam-Roudy, Houry; Sejbæk, Tobias; Tsakiri, Anna; Weglewski, Arkadiusz; Sorensen, Per Soelberg; Magyari, Melinda.

I: Neurology, Bind 92, Nr. 16, 01.04.2019, s. e1811-e1820.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Comparative effectiveness of teriflunomide and dimethyl fumarate

T2 - A nationwide cohort study

AU - Buron, Mathias Due

AU - Chalmer, Thor Ameri

AU - Sellebjerg, Finn

AU - Frederiksen, Jette

AU - Góra, Monika Katarzyna

AU - Illes, Zsolt

AU - Kant, Matthias

AU - Mezei, Zsolt

AU - Petersen, Thor

AU - Rasmussen, Peter Vestergaard

AU - Roshanisefat, Homayoun

AU - Hassanpour-Kalam-Roudy, Houry

AU - Sejbæk, Tobias

AU - Tsakiri, Anna

AU - Weglewski, Arkadiusz

AU - Sorensen, Per Soelberg

AU - Magyari, Melinda

N1 - © 2019 American Academy of Neurology.

PY - 2019/4/1

Y1 - 2019/4/1

N2 - OBJECTIVE: To compare on-treatment efficacy and discontinuation outcomes in teriflunomide (TFL) and dimethyl fumarate (DMF) in the treatment of relapsing-remitting multiple sclerosis (RRMS) in a real-world setting.METHODS: We identified all patients starting TFL or DMF from the Danish Multiple Sclerosis Registry and compared on-treatment efficacy outcomes between DMF using TFL, adjusted for clinical baseline variables and propensity score-based methods.RESULTS: We included 2,236 patients in the study: 1,469 patients on TFL and 767 on DMF. Annualized relapse rates (ARRs) in TFL and DMF were 0.16 (95% confidence interval [CI] 0.13-0.20) and 0.09 (95% CI 0.07-0.12), respectively. Relapse rate ratio for DMF/TFL was 0.58 (95% CI 0.46-0.73, p < 0.001). DMF had a higher relapse-free survival proportion at 48 months of follow-up (p < 0.05). We observed no difference in Expanded Disability Status Scale score worsening. Discontinuations due to disease breakthrough were 10.2% (95% CI 7.6%-12.8%) and 22.1% (95% CI 19.2%-25.0%) for DMF and TFL, respectively. A subgroup analysis of ARRs in 708 patients with available baseline MRI T2 lesion amount reported similar results after adjustment.CONCLUSION: We found lower ARR, higher relapse-free survival, and lower incidence of discontinuation due to disease breakthrough on treatment with DMF compared with TFL.CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with RRMS, DMF is more effective in preventing relapses and has lower discontinuation due to disease breakthrough compared with TFL.

AB - OBJECTIVE: To compare on-treatment efficacy and discontinuation outcomes in teriflunomide (TFL) and dimethyl fumarate (DMF) in the treatment of relapsing-remitting multiple sclerosis (RRMS) in a real-world setting.METHODS: We identified all patients starting TFL or DMF from the Danish Multiple Sclerosis Registry and compared on-treatment efficacy outcomes between DMF using TFL, adjusted for clinical baseline variables and propensity score-based methods.RESULTS: We included 2,236 patients in the study: 1,469 patients on TFL and 767 on DMF. Annualized relapse rates (ARRs) in TFL and DMF were 0.16 (95% confidence interval [CI] 0.13-0.20) and 0.09 (95% CI 0.07-0.12), respectively. Relapse rate ratio for DMF/TFL was 0.58 (95% CI 0.46-0.73, p < 0.001). DMF had a higher relapse-free survival proportion at 48 months of follow-up (p < 0.05). We observed no difference in Expanded Disability Status Scale score worsening. Discontinuations due to disease breakthrough were 10.2% (95% CI 7.6%-12.8%) and 22.1% (95% CI 19.2%-25.0%) for DMF and TFL, respectively. A subgroup analysis of ARRs in 708 patients with available baseline MRI T2 lesion amount reported similar results after adjustment.CONCLUSION: We found lower ARR, higher relapse-free survival, and lower incidence of discontinuation due to disease breakthrough on treatment with DMF compared with TFL.CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with RRMS, DMF is more effective in preventing relapses and has lower discontinuation due to disease breakthrough compared with TFL.

U2 - 10.1212/WNL.0000000000007314

DO - 10.1212/WNL.0000000000007314

M3 - Journal article

VL - 92

SP - e1811-e1820

JO - Neurology

JF - Neurology

SN - 0028-3878

IS - 16

ER -

Buron MD, Chalmer TA, Sellebjerg F, Frederiksen J, Góra MK, Illes Z et al. Comparative effectiveness of teriflunomide and dimethyl fumarate: A nationwide cohort study. Neurology. 2019 apr 1;92(16):e1811-e1820. https://doi.org/10.1212/WNL.0000000000007314