Therapeutic Advances in Neurological Disorders (Jan 2010)

A randomized, blinded, parallel-group, pilot trial of mycophenolate mofetil (CellCept) compared with interferon beta-1a (Avonex) in patients with relapsing-remitting multiple sclerosis

  • Elliot M. Frohman,
  • Gary Cutter,
  • Gina Remington,
  • Hongjiang Gao,
  • Howard Rossman,
  • Bianca Weinstock-Guttman,
  • Jacqueline E. Durfee,
  • Amy Conger,
  • Ellen Carl,
  • Katherine Treadaway,
  • Eric Lindzen,
  • Amber Salter,
  • Teresa C. Frohman,
  • Anjali Shah,
  • Angela Bates,
  • Jennifer L. Cox,
  • Michael G. Dwyer,
  • Olaf Stuve,
  • Benjamin M. Greenberg,
  • Michael K. Racke,
  • Robert Zivadinov

DOI
https://doi.org/10.1177/1756285609353354
Journal volume & issue
Vol. 3

Abstract

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Background: Mycophenolate mofetil (MMF, CellCept ® ) has been utilized as an antirejection agent in transplant recipients and in patients with myriad autoimmune disorders including multiple sclerosis (MS). Objective: To investigate radiographic and clinical safety involving monotherapy use of daily oral MMF (1 g b.i.d.) versus weekly intramuscular interferon beta 1a (Avonex ® at 30 mcg) in relapsing-remitting MS (RRMS). Methods: We organized a randomized, serial, 6-monthly, MRI-blinded, parallel-group multicenter pilot study to determine the safety of MMF versus interferon beta monotherapy in 35 untreated patients with RRMS, all of whom exhibited evidence of gadolinium (Gd) enhancement on a screening MRI of the brain. The primary outcome was the reduction in the cumulative mean number of combined active lesions (CAL), new Gd-enhancing lesions, and new T2 lesions on MRI analyses. Results: Both interferon beta and MMF appeared safe and well tolerated in the majority of patients. There was no difference between MMF therapy and the standard regimen of interferon beta therapy on the primary safety MRI endpoints of the study. However, the MMF group showed a trend toward a lower accumulation of combined active lesions, CAL, Gd and T2 lesions when compared with interferon beta treated patients. Conclusions: The results from this pilot study suggest that the application of MMF monotherapy in MS deserves further exploration.