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 language | English (US) |
|---|---|
| Pages (from-to) | 446-451 |
| Number of pages | 6 |
| Journal | CNS Neuroscience and Therapeutics |
| Volume | 20 |
| Issue number | 5 |
| DOIs | |
| State | Published - 2014 |
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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 journal › Article
}
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 -