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Fingolimod therapy in early multiple sclerosis: an efficacy analysis of the TRANSFORMS and FREEDOMS studies by time since first symptom.
- Source :
-
CNS neuroscience & therapeutics [CNS Neurosci Ther] 2014 May; Vol. 20 (5), pp. 446-51. Date of Electronic Publication: 2014 Mar 31. - Publication Year :
- 2014
-
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.<br />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.<br />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).<br />Conclusion: Fingolimod 0.5 mg is highly effective in reducing relapses and MRI activity in patients early in the MS disease course.<br /> (© 2014 John Wiley & Sons Ltd.)
- Subjects :
- Adult
Disease Progression
Female
Fingolimod Hydrochloride
Gadolinium
Humans
Immunologic Factors therapeutic use
Interferon beta-1a
Interferon-beta therapeutic use
Kaplan-Meier Estimate
Magnetic Resonance Imaging methods
Male
Multiple Sclerosis pathology
Secondary Prevention
Sphingosine therapeutic use
Time Factors
Treatment Outcome
Immunosuppressive Agents therapeutic use
Multiple Sclerosis drug therapy
Propylene Glycols therapeutic use
Sphingosine analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1755-5949
- Volume :
- 20
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- CNS neuroscience & therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 24684973
- Full Text :
- https://doi.org/10.1111/cns.12235