A new combination treatment regime, for patients with aggressive forms of multiple sclerosis (MS), is offering new hope to a group of patients who would otherwise be at high risk of early disability according to British research due to be published in the Journal of Neurology.

The treatment regime, consisting of a limited course of mitoxantrone (an immunosuppressant normally used to treat cancer) followed by long-term glatiramer acetate (Copaxone - one of two classes of disease modifying drugs for use in relapsing-remitting multiple sclerosis), has proven so successful in this early trial that a full controlled study is now being initiated at 10 centres across the UK to examine the combination further. Investigators are now looking to enrol suitable patients with MS.

In this ‘open’ trial the combination was found to provide a rapid and sustained suppression of relapses in MS patients experiencing frequent, recurrent and disabling attacks (90% reduction in annualised relapse rate maintained, to date, for a mean of 36 months). It was also shown to improve, or at least stabilise, existing levels of disability in the 27 patients who had extremely active forms of the disease. Follow up in early patients now extends to over 5 years.

The patients treated with this new protocol, developed by a research team at the Walton Centre for Neurology and Neurosurgery in Liverpool, had all been diagnosed with Relapsing Remitting MS for less than 5 years and showed clear signs that their disease was likely to progress quickly producing early and severe disability.

Dr Mike Boggild, Consultant Neurologist at the Walton Centre and principal investigator of this research commented:’ This novel treatment regime has proved remarkably effective in a group of patients with early MS and a poor prognosis. Though there are certain risks, associated particularly with the use of Mitoxantrone, we have been able to limit these by using this agent for just a short ‘induction’ period and, balanced against the high risk of early disability for these patients, the outcomes we have seen appear to justify this approach. The effect is so striking that we suspect the two drugs may be acting synergistically’

Karen Ayres, 28 from Warrington is a patient who has benefited from the new treatment protocol. She said: ‘Lying paralysed in hospital, I truly believed that I would never get the chance to travel again, let alone go back to university to study. Without mitoxantrone and Copaxone treatment, I simply don’t think it would have been possible - it is not an exaggeration to say that I feel as though the treatment has given me my life back. I have been able to take up my beloved backpacking again and I am currently studying for a PhD. MS really doesn’t spell the end of your life’

Mitoxantrone, the first immunosuppressant to be approved by the United States Food and Drug Administration (FDA) for use in MS, has previously been shown in randomised controlled studies in the US to reduce relapses in MS, but due to its potential toxicity its use is limited. Previous attempts to extend its effectiveness with subsequent use of interferon-beta have been disappointing, so researchers at the Walton Centre decided to use the alternative class of disease modifying drug, glatiramer acetate (Copaxone).

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