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| |  AAN MEETING: Treatment With Higher Dose Rebif Reduces MS Activity VANCOUVER, BC and MINNEAPOLIS, MN -- May 1, 1998 -- New results from the PRISMS study, the largest clinical trial completed in relapsing-remitting multiple sclerosis (MS), were presented today at the 50th annual meeting of the American Academy of Neurology. In this study, Ares-Serono’s Rebif (interferon beta-1a) at two doses (66 mcg and 132 mcg weekly) reduced the number of relapses and delayed progression of disability compared to placebo, in a dose-related fashion. MRI findings included significant reductions in disease activity and accumulation of burden of disease, supporting the positive clinical results and the profound effect of the high dose (132 mcg). Relapsing-remitting MS (RRMS) is the most common form of the disease, involving alternating periods of increased disability (relapses) and recovery (remissions). Over time, most patients develop permanent disability. Magnetic Resonance Imaging (MRI) provides a window on the disease's pathology: MRI burden of disease represents the total area of the brain affected by lesions or plaques, and MRI disease activity measures flares of inflammatory activity and morphological changes such as appearance or enlargement of lesions. "For patients and their neurologists, it is comforting that both studied doses work and are safe and the higher dose of IFN beta-1a provides greater benefit without increased risk," said Donald Paty, M.D., director of research, MS programs, Vancouver Hospital &- Health Sciences Centre, University of British Columbia hospital site and professor of neurology, UBC. "It is intuitive that reductions of MRI activity of 88 percent, as seen with the high dose in this study, will have a beneficial impact on the long-term clinical picture. “This is the highest dose of interferon beta we have used in MS to date and is a significant addition to the arsenal of drugs we have to treat this chronic and debilitating disease." During the AAN conference, two back-to-back presentations focused on MRI disease activity. A subgroup of 198 patients, from a total of 560 patients enrolled in the PRISMS clinical trial, underwent 11 monthly MRI scans, two before and nine after beginning treatment. "The methodology used in this MRI study has set a new standard, and will serve as a model and reference for the monitoring and evaluation of this disease in clinical trials in the treatment of MS," Dr. Paty said. In the first presentation, patients were grouped according to the number of active lesions measured at the beginning of the study: no activity (no lesions), low activity (one to two lesions) and high activity (greater than two lesions). In the placebo group, the level of baseline MRI activity predicted the level of activity during the study. Patients with higher baseline activity accumulated more activity in the placebo group but showed proportionally greater reduction in activity when treated, particularly with the higher dose. The second presentation explored the ability of different methods of MRI assessment to detect treatment effect in MS studies. Proton density/T2 (PD/T2) scans detect morphological activity and T1-gadolinium enhanced (T1-Gd) scans measure inflammatory activity. These types of activity were evaluated separately and in combination. Although fewer active lesions were identified with PD/T2, this method was statistically better able to identify treatment and dose effects than was gadolinium activity.
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