title: A randomized, blinded, parallel-group, pilot trial of mycophenolate mofetil (CellCept) compared with interferon beta-1a (Avonex) in patients with relapsing-remitting multiple sclerosis.
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.
authors.affiliation: Departments of Neurology and Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
authors.forename: Elliot M
authors.initials: EM
authors.lastname: Frohman
authors.forename: Gary
authors.initials: G
authors.lastname: Cutter
authors.forename: Gina
authors.initials: G
authors.lastname: Remington
authors.forename: Hongjiang
authors.initials: H
authors.lastname: Gao
authors.forename: Howard
authors.initials: H
authors.lastname: Rossman
authors.forename: Bianca
authors.initials: B
authors.lastname: Weinstock-Guttman
authors.forename: Jacqueline E
authors.initials: JE
authors.lastname: Durfee
authors.forename: Amy
authors.initials: A
authors.lastname: Conger
authors.forename: Ellen
authors.initials: E
authors.lastname: Carl
authors.forename: Katherine
authors.initials: K
authors.lastname: Treadaway
authors.forename: Eric
authors.initials: E
authors.lastname: Lindzen
authors.forename: Amber
authors.initials: A
authors.lastname: Salter
authors.forename: Teresa C
authors.initials: TC
authors.lastname: Frohman
authors.forename: Anjali
authors.initials: A
authors.lastname: Shah
authors.forename: Angela
authors.initials: A
authors.lastname: Bates
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Cox
authors.forename: Michael G
authors.initials: MG
authors.lastname: Dwyer
authors.forename: Olaf
authors.initials: O
authors.lastname: Stüve
authors.forename: Benjamin M
authors.initials: BM
authors.lastname: Greenberg
authors.forename: Michael K
authors.initials: MK
authors.lastname: Racke
authors.forename: Robert
authors.initials: R
authors.lastname: Zivadinov