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

Research output: Contribution to journalArticle

25 Citations (Scopus)

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

Fingerprint

Mycophenolic Acid
Relapsing-Remitting Multiple Sclerosis
Interferon-beta
Gadolinium
Safety
Multiple Sclerosis
Multicenter Studies
Interferon beta-1a
Brain
Therapeutics

Keywords

  • CellCept
  • Immunosuppression
  • Interferon beta 1a
  • MRI activity
  • Mycophenolate mofetil
  • Relapsing-remitting multiple sclerosis

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology
  • Pharmacology

Cite this

A randomized, blinded, parallel-group, pilot trial of mycophenolate mofetil (CellCept) compared with interferon beta-1a (Avonex) in patients with relapsing-remitting multiple sclerosis. / Frohman, Elliot; Cutter, Gary; Remington, Gina; Gao, Hongjiang; Rossman, Howard; Weinstock-Guttman, Bianca; Durfee, Jacqueline E.; Conger, Amy; Carl, Ellen; Stuve, Olaf; Greenberg, Benjamin; Salter, Amber; Frohman, Teresa C.; Shah, Anjali; Bates, Angela; Cox, Jennifer L.; Dwyer, Michael G.; Shah, Anjali; Greenberg, Benjamin M.; Racke, Michael K.; Zivadinov, Robert.

In: Therapeutic Advances in Neurological Disorders, Vol. 3, No. 1, 01.2010, p. 15-28.

Research output: Contribution to journalArticle

Frohman, E, Cutter, G, Remington, G, Gao, H, Rossman, H, Weinstock-Guttman, B, Durfee, JE, Conger, A, Carl, E, Stuve, O, Greenberg, B, Salter, A, Frohman, TC, Shah, A, Bates, A, Cox, JL, Dwyer, MG, Shah, A, Greenberg, BM, Racke, MK & Zivadinov, R 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', Therapeutic Advances in Neurological Disorders, vol. 3, no. 1, pp. 15-28. https://doi.org/10.1177/1756285609353354
Frohman, Elliot ; Cutter, Gary ; Remington, Gina ; Gao, Hongjiang ; Rossman, Howard ; Weinstock-Guttman, Bianca ; Durfee, Jacqueline E. ; Conger, Amy ; Carl, Ellen ; Stuve, Olaf ; Greenberg, Benjamin ; Salter, Amber ; Frohman, Teresa C. ; Shah, Anjali ; Bates, Angela ; Cox, Jennifer L. ; Dwyer, Michael G. ; Shah, Anjali ; Greenberg, Benjamin M. ; Racke, Michael K. ; Zivadinov, Robert. / A randomized, blinded, parallel-group, pilot trial of mycophenolate mofetil (CellCept) compared with interferon beta-1a (Avonex) in patients with relapsing-remitting multiple sclerosis. In: Therapeutic Advances in Neurological Disorders. 2010 ; Vol. 3, No. 1. pp. 15-28.
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T1 - A randomized, blinded, parallel-group, pilot trial of mycophenolate mofetil (CellCept) compared with interferon beta-1a (Avonex) in patients with relapsing-remitting multiple sclerosis

AU - Frohman, Elliot

AU - Cutter, Gary

AU - Remington, Gina

AU - Gao, Hongjiang

AU - Rossman, Howard

AU - Weinstock-Guttman, Bianca

AU - Durfee, Jacqueline E.

AU - Conger, Amy

AU - Carl, Ellen

AU - Stuve, Olaf

AU - Greenberg, Benjamin

AU - Salter, Amber

AU - Frohman, Teresa C.

AU - Shah, Anjali

AU - Bates, Angela

AU - Cox, Jennifer L.

AU - Dwyer, Michael G.

AU - Shah, Anjali

AU - Greenberg, Benjamin M.

AU - Racke, Michael K.

AU - Zivadinov, Robert

PY - 2010/1

Y1 - 2010/1

N2 - 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.

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KW - MRI activity

KW - Mycophenolate mofetil

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