Citation

Frohman EM, Cutter G, Gao H, Salter A, Remington G, Conger A, Treadaway K, Frohman TC, Bates A, Stuve O, Greenberg BM, Rossman H, Weinstock Guttman B, Lindzen E, Durfee JE, Carl E, Dwyer MG, Shah A, Cox JL, Racke MK, Zivadinov R. Ther. Adv. Neurol. Disorders 2010; 3(1): 15-28.

Copyright

(Copyright © 2010)

DOI

10.1177/1756285609353354

PMID

unavailable

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. © 2010, SAGE Publications. All rights reserved.

Language: en

Keywords

adult; human; female; male; injury; insomnia; abdominal pain; pilot study; depression; screening; anxiety; randomized controlled trial; suicide attempt; clinical trial; treatment outcome; neuroimaging; fatigue; article; controlled study; clinical article; priority journal; controlled clinical trial; double blind procedure; headache; nuclear magnetic resonance imaging; influenza; drug safety; backache; drug efficacy; diarrhea; drug tolerability; nausea; drug withdrawal; multicenter study; relapse; side effect; flu like syndrome; pruritus; leg pain; paresthesia; multiple sclerosis; radiography; laboratory test; monotherapy; dizziness; face pain; mycophenolic acid 2 morpholinoethyl ester; urinary tract infection; tooth infection; speech disorder; beta1a interferon; incontinence; injection site reaction; upper respiratory tract infection; epistaxis; taste disorder; weakness; hemorrhoid; sinusitis; therapy effect; eye infection; abscess; gadolinium; contrast enhancement; CellCept; ear infection; immunosuppression; interferon beta 1a; metal taste; MRI activity; mycophenolate mofetil; relapsing-remitting multiple sclerosis; trigeminal nerve disease