Abstract: Combination Interferon-Beta 1a and Mycophenolate Mofetil in RRMS (The 27th Annual Meeting of the CMSC and the 5th Cooperative Meeting of the CMSC-ACTRIMS)

Thursday, May 30, 2013

Jacqueline A Nicholas, MD , Neurology, The Ohio State University Wexner Medical Center, Columbus, OH

Yuhong Yang, MD , Neurology, The Ohio State University Wexner Medical Center, Columbus, OH

Caroline Schaffer, - , Neurology, The Ohio State University Wexner Medical Center, Columbus, OH

Morgan Savel, BS , Neurology, The Ohio State University Wexner Medical Center, Columbus, OH

Kyle Porter, M.A.S. , Center for Biostatistics, The Ohio State University, Columbus, OH

Claudia Kirsch, MD , Radiology, The Ohio State University Wexner Medical Center, Columbus, OH

Michael K Racke, MD , The Ohio State University Wexner Medical Center, Columbus, OH

Aaron Boster, MD , Neurology, The Ohio State University Wexner Medical Center, Columbus, OH

Kottil Rammohan, MD , Neurology, University of Miami, Miami, FL

Background: Combination of mycophenylate mofetil (MM) with interferon beta-1a (IFN-b1a) has the potential to improve tolerability of interferon while enhancing the long-term efficacy of this agent in patients with relapsing remitting multiple sclerosis (RRMS).

Objectives: To examine the efficacy and safety of combination MM with IFN-b1a in the management of patients with RRMS.

Methods: A one-year, open-label, prospective, unblinded pilot study where McDonald 2005 RRMS patients were randomized to either IFN-b1a sq TIW monotherapy (n=15) vs. combination IFN + MM 2000 mg daily from day 0 to 28 weeks (n=14). Demographics, neurologic examination, EDSS, MSFC, MSQLI, brain MRI, serum blood counts and liver function tests were collected at baseline and at week 52. The study was approved by our IRB.

Results: There were no significant between-group differences in baseline demographics (mean ± SD, median): Age (IFN+MM) 36.4±9.9, 42 vs. (IFN) 41.3±10.9, 43; Female 60% vs. 46.7%; Caucasian 80% vs. 93%, EDSS 2.7±2.0, 2.5 vs. 3.1±1.1, 3.0. There were no between-group differences in MxA expression at weeks 0, 4, 16, 28, 40, or 52. There were no significant between-group differences for annualized relapse rate, EDSS, MSFC, MSQLI or adverse events. The number of new/enlarging T2 lesions at 52 weeks was significantly higher in IFN vs IFN+MM (fisher exact test, p=0.046). There were no significant between-group differences in T1 gad lesions. One IFN+MM patient died from suicide.

Conclusions: Patients in both arms remained stable with regards to ARR and measures of disease progression throughout the trial. The interferon arm demonstrated a significantly higher number of new/enlarging T2 lesions at 52 weeks as compared to the IFN + MM arm. The interferon and combination arms did not have progression of disability by EDSS over 52 weeks. Serious adverse events occurred including death from suicide which highlights the need for increased surveillance for mood disorders and suicidal ideation in the MS population.

DX47 Combination Interferon-Beta 1a and Mycophenolate Mofetil in RRMS