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Combination Mycophenolate Mofetil (CellCept) and Interferon Beta (Rebif/Betaferon) Safe and Effective in Advanced MS: Presented at ECTRIMS
By Bruce Sylvester
THESSALONIKI, GREECE -- October 6, 2005 -- Combination treatment with mycophenolate mofetil (MMF, CellCept) and interferon beta (INF-b, Rebif, or Betaferon) has a beneficial effect on progression of disability in patients with multiple sclerosis (MS), and can stabilise the disease course without major adverse effects, researchers reported here on September 30th at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
The combination has the potential to become a cotherapy for MS patients not responding to established monotherapies, said Lodi Gogovska, MD, assistant professor of medicine, University of Skopje, Skopje, Macedonia.
"We saw a benefit from this combination treatment in 15 patients, and the combination was, notably, well tolerated in most patients," she said.
Dr. Gogovska and colleagues evaluated the combination of MMF and INF-b in 17 patients who had active disease and had relapsed in the preceding 6 months or secondary progressive MS without recent relapses but whose disability had worsened in the previous 6 months.
"We saw potential in this small study for a combination treatment that might prove to be of great help to certain populations of MS patients, and the implication of this study is certainly that this line of investigation should be pursued."
The open-label study enrolled patients with secondary progressive MS, with deterioration of 1 point or more in Expanded Disability Status Scale (EDSS) score during 6 months preceding enrollment, or with relapsing-remitting MS (RRMS) with 2 or more relapses in the previous 6 months.
The researchers administered CellCept 1 to 1.5 g/day for 18 months in addition to ongoing Rebif or Betaferon therapy.
Primary outcome measures were change in EDSS and in the proportion of patients who improved, remained stable, or worsened, defined as a change of at least 1 point in EDSS for patients with baseline EDSS 4.5 or less, and a change of 0.5 point for those with baseline EDSS 5.0 or more points.
Safety outcomes were measured by incidence of adverse events occurring during the 18 months of the study.
Results showed a treatment benefit in 88.2% of subjects, with 70.5% of them showing improvement and 17.6% remaining stable. Two patients (11.7%) deteriorated.
"This study also showed a significant beneficial effect on relapse rate and on proportion of relapse-free patients," the authors noted. "No major side effects were observed and the treatment was well tolerated."
"Combination of MMF and Interferon beta has influence on disability progression in MS," they concluded. "Its potential to stabilise the disease course and safe side effect profile would make this combination a promising treatment option for patients with MS who do not seem to benefit from 1 of the established therapies."
[Presentation title: Interferon Beta Combined With Mycophenolate Mofetil in Multiple Sclerosis. Poster 640]
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