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Addition of oral Methylprednisolone to standard treatment of subcutaneous Interferon beta-1a substantially reduces the relapse rate in patients with relapsing-remitting multiple sclerosis.

Like other treatments for multiple sclerosis, Interferon beta-1a is only partly effective, and second-line therapies ( Mitoxantrone and Natalizumab ) with enhanced effectiveness can have serious side-effects eg, Mitoxantrone can cause leukaemia in 1 per 150 patients treated. Thus, new safe and effective treatments are needed.

The study ( the NORMIMS trial ) analysed 130 patients with relapsing-remitting multiple sclerosis in 29 centres in Denmark, Norway, Sweden, and Finland, and was carried out by Per Soelberg Sorensen, Danish Multiple Sclerosis Research Center, Rigshospitalet, Copenhagen, Denmark, and colleagues. Each patient had had at least one relapse in the previous 12 months, and was being treated with subcutaneous Interferon beta-1a. Patients were randomised to receive, in addition to Interferon beta-1a, 200mg of oral Methylprednisolone ( 66 patients ) or matching placebo ( 64 ) on five consecutive days, every four weeks for 96 weeks.

The Researchers found that a high number of patients had withdrawn from the study before week 96 ( 26% of Methylprednisolone group, 17% of placebo group ).
Methylprednisolone group withdrawals were mainly because of side-effects, and those from the placebo group mainly because of lack of effect. The mean yearly relapse rate was 22% in the Methylprednisolone group, versus 59% in the placebo group — and was thus nearly three times higher for placebo patients compared with Methylprednisolone patients. Sleep disturbance and neurological and psychiatric symptoms were the most frequent side-effects recorded in the MP group; but bone mineral density ( which can be reduced with prolonged therapy with glucocorticoids such as Methylprednisolone ) had not changed after 96 weeks.

The Authors concluded that oral Methylprednisolone given in pulses every 4 weeks as an add-on therapy to subcutaneous Interferon beta-1a in patients with relapsing-remitting multiple sclerosis leads to a significant reduction in relapse rate. However, because of the small number of patients and the high dropout rate, these findings need to be corroborated in larger cohorts.

Jeffrey A Cohen, Mellen Center for Multiple Sclerosis Treatment and Research, Neurological Institute, Cleveland Clinic ( USA ), commented that despite the results from NORMIMS, whether or not addition of oral Methylprednisolone to Interferon beta-1a improves outcomes for relapsing-remitting multiple sclerosis patients remains uncertain. This will remain the case until the findings of the MECOMBIN study — which is a similar trial in a larger number of patients — are published.

Source: Lancet Neurology, 2009


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