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 Scopus citations


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
Issue number5
StatePublished - 2014



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

ASJC Scopus subject areas

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

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