A one-year prospective, randomized, placebo-controlled, quadruple-blinded, phase II safety pilot trial of combination therapy with interferon beta-1a and mycophenolate mofetil in early relapsing-remitting multiple sclerosis (TIME MS)

Gina M. Remington, Katherine Treadaway, Teresa Frohman, Amber Salter, Olaf Stuve, Michael K. Racke, Kathleen Hawker, Federica Agosta, Maria Pia Sormani, Massimo Filippi, Elliot M. Frohman

Research output: Contribution to journalArticle

21 Scopus citations

Abstract

Background: Mycophenolate mofetil (MMF) is an oral DNA base synthesis inhibitor with immunomodulatory effects on B cells, T cells, and macrophages. Objective: To conduct a safety and tolerability pilot study of interferon beta-1a (IFN-b1a) in combination with either placebo or oral MMF in multiple sclerosis (MS). Methods: Twenty-four treatment-naïve R-RMS patients participated in a one-year prospective, placebo-controlled, blinded, safety pilot clinical trial. Every patient injected weekly intramuscular interferon beta-1a. The cohort was then randomized (1 : 1) to either active oral MMF or identical-appearing placebo tablets. Clinical evaluations were assessed every 3 months, along with brain MRI scans performed at baseline and repeated every 60 days for one year. Comprehensive laboratory assessments were monitored for safety, along with adverse events. Results: In this small pilot investigation, no differences were identified between the two treatment groups with respect to patient-reported adverse events, MRI metrics, or laboratory abnormalities. Notwithstanding these observations, and the limited number of patients treated, trends appeared to favor the combination therapy regimen. Conclusions: The combination treatment regimen of interferon beta-1a and MMF appeared to be well tolerated in this pilot study. Despite the small sample size, therapeutic trends were observed in favor of combination therapy. An adequately powered controlled trial of MMF in MS appears warranted.

Original languageEnglish
Pages (from-to)3-13
Number of pages11
JournalTherapeutic Advances in Neurological Disorders
Volume3
Issue number1
DOIs
StatePublished - Jan 2010
Externally publishedYes

Keywords

  • CellCept
  • immunosuppression
  • mycophenolate mofetil
  • relapsing-remitting multiple sclerosis
  • treatment naïve

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