TY - JOUR
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 M.
AU - Cutter, Gary
AU - Gao, Hongjiang
AU - Salter, Amber
AU - Remington, Gina
AU - Conger, Amy
AU - Treadaway, Katherine
AU - Frohman, Teresa C.
AU - Bates, Angela
AU - Stuve, Olaf
AU - Greenberg, Benjamin M.
AU - Rossman, Howard
AU - Weinstock Guttman, Bianca
AU - Lindzen, Eric
AU - Durfee, Jacqueline E.
AU - Carl, Ellen
AU - Dwyer, Michael G.
AU - Shah, Anjali
AU - Cox, Jennifer L.
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.
AB - 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.
KW - CellCept
KW - MRI activity
KW - immunosuppression
KW - interferon beta 1a
KW - mycophenolate mofetil
KW - relapsing-remitting multiple sclerosis
UR - http://www.scopus.com/inward/record.url?scp=77953404087&partnerID=8YFLogxK
U2 - 10.1177/1756285609353354
DO - 10.1177/1756285609353354
M3 - Article
C2 - 21180633
AN - SCOPUS:77953404087
SN - 1756-2856
VL - 3
SP - 15
EP - 28
JO - Therapeutic Advances in Neurological Disorders
JF - Therapeutic Advances in Neurological Disorders
IS - 1
ER -