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

Research output: Contribution to journalArticlepeer-review

27 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)15-28
Number of pages14
JournalTherapeutic Advances in Neurological Disorders
Volume3
Issue number1
DOIs
StatePublished - Jan 2010

Keywords

  • CellCept
  • MRI activity
  • immunosuppression
  • interferon beta 1a
  • mycophenolate mofetil
  • relapsing-remitting multiple sclerosis

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