Published: April 17, 2010
Reviewed by Ari Green, MD; Assistant Professor, University of California, San Francisco.
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TORONTO — Multiple sclerosis patients treated with glatiramer acetate (Copaxone) reported a trend to lessening of the fatigue caused by the disease, researchers said here at the annual meeting of the American Academy of Neurology.
After six months, 59.1% of the patients given the immunomodulator had experienced an improvement of fatigue severity as measured with the total Modified Fatigue Impact Scale score compared with baseline, Norman Putzki, MD, of the Klinik fur Neurologie und Neurophysiologie in St. Gallen, Switzerland, and colleagues reported. “Fatigue is one of the most frequent and most debilitating symptoms of multiple sclerosis,” Putzki and his noted in their poster presentation. “Its origin is poorly understood, but immunologic mechanisms may play a role.” The researchers scrutinized outcomes with glatiramer acetate because the drug is thought to modulate T-cell activation. Glatiramer acetate is also believed to favorably impact the Th1 to Th2 ratio — the subsets of T cells that produce different cytokine activity, which characterizes different immunologic responses. However, other recent work also suggests that GA may exhibit its primary clinical effect via modulation of antigen presentation on monocytes and B cells and not by changing T cell activity. Putzki and colleagues enrolled 29 patients diagnosed with the remitting-relapsing form of multiple sclerosis. They had been diagnosed for a mean of 34 months and their mean Expanded Disability Status Scale score was 2.2 — indicating minimal to mild disability. These patients — 20 of whom were women — were naïve to multiple sclerosis treatment when they were started on glatiramer acetate. Their scores on the Modified Fatigue Impact Scale at baseline were compared with similar scores at the end of six months in this prospective, observational study. “The majority of patients who initiate GA experience a mild decrease of fatigue severity while fatigue worsening is rare,” Putzki reported. The mean scores of the physical subscore of the scale showed a tendency to decrease from baseline to month 6 while the other subscores and the total scores did not show significant changes during the investigational period. Mean Functional System Scores decreased from 4.4 to 4.1 (P=0.06). Only a few patients scored worse six months after treatment initiation with glatiramer acetate, the researchers reported. A limitation of the study is that it is difficult to draw definitive conclusions from very small open label trials such as this one.
The study was supported by Teva, Germany. Putzki disclosed financial relationships with Biogen Idec, Merck Serono, Schering, Teva Neuroscience, sanofi-aventis, Allegan, Ipsen and Novartis. Other authors disclosed financial relationships with Antisense Therapeutics, Bayer, GlaxoSmithKline and Pfizer. |
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Primary source: Neurology (Supplement) 2010 Annual Meeting Program
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