Fingolimod therapy in early multiple sclerosis

An efficacy analysis of the transforms and freedoms studies by time since first symptom

Mark Agius, Xiangyi Meng, Peter Chin, Augusto Grinspan, Ronny Hashmonay

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Aims: The phase 3 TRANSFORMS and FREEDOMS studies established the efficacy of fingolimod in reducing multiple sclerosis (MS) relapses and magnetic resonance imaging lesions compared with intramuscular (IM) interferon (IFN) β-1a and placebo over 12 and 24 months, respectively. Methods: To investigate the efficacy of fingolimod at the approved 0.5 mg dose in patients early in the MS disease course, post hoc subgroup analyses of TRANSFORMS (n = 272) and FREEDOMS (n = 217) data were conducted in patients who experienced their first MS symptom <3 years before randomization. Results: Fingolimod 0.5 mg reduced annualized relapse rate by 73.4% (P = 0.0002) versus IFNβ-1a IM and by 67.4% (P < 0.0001) versus placebo in patients with <3 years since first symptom; respective reductions were 45.4% and 51.4% in subgroups of patients with ≥3 years since first symptom. For patients with <3 years since their first symptom, significantly fewer new/newly enlarged T2 lesions were observed with fingolimod versus IFNβ-1a IM (mean number, 1.94 vs. 2.95; P = 0.036) or placebo (4.1 vs. 10.7; P < 0.001); the mean number of gadolinium-enhancing T1 lesions was significantly reduced versus placebo (0.3 vs. 1.1; P < 0.001). Conclusion: Fingolimod 0.5 mg is highly effective in reducing relapses and MRI activity in patients early in the MS disease course.

Original languageEnglish (US)
Pages (from-to)446-451
Number of pages6
JournalCNS Neuroscience and Therapeutics
Volume20
Issue number5
DOIs
StatePublished - 2014

Fingerprint

Multiple Sclerosis
Placebos
Interferons
Recurrence
Therapeutics
Gadolinium
Random Allocation
Fingolimod Hydrochloride
Magnetic Resonance Imaging

Keywords

  • Early medical intervention
  • Fingolimod
  • Interferon β
  • Pharmacotherapy
  • Relapse

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Physiology (medical)
  • Psychiatry and Mental health
  • Pharmacology
  • Medicine(all)

Cite this

Fingolimod therapy in early multiple sclerosis : An efficacy analysis of the transforms and freedoms studies by time since first symptom. / Agius, Mark; Meng, Xiangyi; Chin, Peter; Grinspan, Augusto; Hashmonay, Ronny.

In: CNS Neuroscience and Therapeutics, Vol. 20, No. 5, 2014, p. 446-451.

Research output: Contribution to journalArticle

Agius, Mark ; Meng, Xiangyi ; Chin, Peter ; Grinspan, Augusto ; Hashmonay, Ronny. / Fingolimod therapy in early multiple sclerosis : An efficacy analysis of the transforms and freedoms studies by time since first symptom. In: CNS Neuroscience and Therapeutics. 2014 ; Vol. 20, No. 5. pp. 446-451.
@article{3734fcdc10954a93bcc6ad90f2d4b580,
title = "Fingolimod therapy in early multiple sclerosis: An efficacy analysis of the transforms and freedoms studies by time since first symptom",
abstract = "Aims: The phase 3 TRANSFORMS and FREEDOMS studies established the efficacy of fingolimod in reducing multiple sclerosis (MS) relapses and magnetic resonance imaging lesions compared with intramuscular (IM) interferon (IFN) β-1a and placebo over 12 and 24 months, respectively. Methods: To investigate the efficacy of fingolimod at the approved 0.5 mg dose in patients early in the MS disease course, post hoc subgroup analyses of TRANSFORMS (n = 272) and FREEDOMS (n = 217) data were conducted in patients who experienced their first MS symptom <3 years before randomization. Results: Fingolimod 0.5 mg reduced annualized relapse rate by 73.4{\%} (P = 0.0002) versus IFNβ-1a IM and by 67.4{\%} (P < 0.0001) versus placebo in patients with <3 years since first symptom; respective reductions were 45.4{\%} and 51.4{\%} in subgroups of patients with ≥3 years since first symptom. For patients with <3 years since their first symptom, significantly fewer new/newly enlarged T2 lesions were observed with fingolimod versus IFNβ-1a IM (mean number, 1.94 vs. 2.95; P = 0.036) or placebo (4.1 vs. 10.7; P < 0.001); the mean number of gadolinium-enhancing T1 lesions was significantly reduced versus placebo (0.3 vs. 1.1; P < 0.001). Conclusion: Fingolimod 0.5 mg is highly effective in reducing relapses and MRI activity in patients early in the MS disease course.",
keywords = "Early medical intervention, Fingolimod, Interferon β, Pharmacotherapy, Relapse",
author = "Mark Agius and Xiangyi Meng and Peter Chin and Augusto Grinspan and Ronny Hashmonay",
year = "2014",
doi = "10.1111/cns.12235",
language = "English (US)",
volume = "20",
pages = "446--451",
journal = "CNS Neuroscience and Therapeutics",
issn = "1755-5930",
publisher = "Wiley-Blackwell",
number = "5",

}

TY - JOUR

T1 - Fingolimod therapy in early multiple sclerosis

T2 - An efficacy analysis of the transforms and freedoms studies by time since first symptom

AU - Agius, Mark

AU - Meng, Xiangyi

AU - Chin, Peter

AU - Grinspan, Augusto

AU - Hashmonay, Ronny

PY - 2014

Y1 - 2014

N2 - Aims: The phase 3 TRANSFORMS and FREEDOMS studies established the efficacy of fingolimod in reducing multiple sclerosis (MS) relapses and magnetic resonance imaging lesions compared with intramuscular (IM) interferon (IFN) β-1a and placebo over 12 and 24 months, respectively. Methods: To investigate the efficacy of fingolimod at the approved 0.5 mg dose in patients early in the MS disease course, post hoc subgroup analyses of TRANSFORMS (n = 272) and FREEDOMS (n = 217) data were conducted in patients who experienced their first MS symptom <3 years before randomization. Results: Fingolimod 0.5 mg reduced annualized relapse rate by 73.4% (P = 0.0002) versus IFNβ-1a IM and by 67.4% (P < 0.0001) versus placebo in patients with <3 years since first symptom; respective reductions were 45.4% and 51.4% in subgroups of patients with ≥3 years since first symptom. For patients with <3 years since their first symptom, significantly fewer new/newly enlarged T2 lesions were observed with fingolimod versus IFNβ-1a IM (mean number, 1.94 vs. 2.95; P = 0.036) or placebo (4.1 vs. 10.7; P < 0.001); the mean number of gadolinium-enhancing T1 lesions was significantly reduced versus placebo (0.3 vs. 1.1; P < 0.001). Conclusion: Fingolimod 0.5 mg is highly effective in reducing relapses and MRI activity in patients early in the MS disease course.

AB - Aims: The phase 3 TRANSFORMS and FREEDOMS studies established the efficacy of fingolimod in reducing multiple sclerosis (MS) relapses and magnetic resonance imaging lesions compared with intramuscular (IM) interferon (IFN) β-1a and placebo over 12 and 24 months, respectively. Methods: To investigate the efficacy of fingolimod at the approved 0.5 mg dose in patients early in the MS disease course, post hoc subgroup analyses of TRANSFORMS (n = 272) and FREEDOMS (n = 217) data were conducted in patients who experienced their first MS symptom <3 years before randomization. Results: Fingolimod 0.5 mg reduced annualized relapse rate by 73.4% (P = 0.0002) versus IFNβ-1a IM and by 67.4% (P < 0.0001) versus placebo in patients with <3 years since first symptom; respective reductions were 45.4% and 51.4% in subgroups of patients with ≥3 years since first symptom. For patients with <3 years since their first symptom, significantly fewer new/newly enlarged T2 lesions were observed with fingolimod versus IFNβ-1a IM (mean number, 1.94 vs. 2.95; P = 0.036) or placebo (4.1 vs. 10.7; P < 0.001); the mean number of gadolinium-enhancing T1 lesions was significantly reduced versus placebo (0.3 vs. 1.1; P < 0.001). Conclusion: Fingolimod 0.5 mg is highly effective in reducing relapses and MRI activity in patients early in the MS disease course.

KW - Early medical intervention

KW - Fingolimod

KW - Interferon β

KW - Pharmacotherapy

KW - Relapse

UR - http://www.scopus.com/inward/record.url?scp=84898688274&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84898688274&partnerID=8YFLogxK

U2 - 10.1111/cns.12235

DO - 10.1111/cns.12235

M3 - Article

VL - 20

SP - 446

EP - 451

JO - CNS Neuroscience and Therapeutics

JF - CNS Neuroscience and Therapeutics

SN - 1755-5930

IS - 5

ER -