Setbacks In Patients With Relapsing-Remitting Multiple Sclerosis Can Be Reduced If Methylprednisolone Is Added To Interferon Beta

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Main Category: Multiple Sclerosis
Article Date: 05 May 2009 - 0:00 PDT

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Conclusions reported in an Article published Online first, as well as in the June edition of The Lancet Neurology, and the announcement made at the American Academy of Neurology meeting in Seattle, USA, all coincide that the substantial decline of the deterioration rate in patients with relapsing-remitting multiple sclerosis (RRMS) can be accomplished by adding oral methylprednisolone (MP) to the standard treatment of subcutaneous interferon beta-1a (IFB1a).

Dr Peter Soelberg Sorensen and his colleagues, from the Danish Multiple Sclerosis Research Center, in Rigshospitalet, Copenhagen, Denmark, conducted a study (the NORMIMS* trial) including 130 patients all with RRMS, who had at least one reversion in the last twelve months and were being treated with subcutaneous IFB1a. These patients were all chosen from 29 centers located in Denmark, Norway, Sweden, and Finland. New safer and effective cures are needed, due to the reason that the treatment IFB1a is only somewhat effective, and other second line-therapies like mitoxantrone and natalizumab which have a superior effectiveness can also have serious health effects, as for example mitoxantrone can be a cause of leukemia in 1 out of 150 patients treated. The patients included in this study where chosen at random to receive in addition to IFB1a, 200mg of oral MP in 66 patients and 64 patients with a matching placebo for five consecutive days, every four weeks for 96 weeks.

The study reflects several important conclusions: 43% of the patients, (26% of MP group and 17% of placebo group) withdrew from the study before week 96. The withdrawals of the MP group were due to important side effects like sleep disturbance and neurological and psychiatric symptoms, and the placebo withdrawals were mainly because they had no effects at all. The average yearly set back rate was 22% in the MP group versus 59% in the placebo group representing three times higher setbacks in the placebo patients. Bone mineral density which can be reduced with extended glucocorticoid therapy, such as MP, remained the same after 96 weeks.

The authors write in conclusion: "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."

In a supplementary observation, Dr Jeffrey A Cohen, Mellen Center for Multiple Sclerosis Treatment and Research, Neurological Institute, Cleveland Clinic, Ohio, USA, points out that whether the addition of oral MP to IFB1a improves outcomes for RRMS patients is still doubtful, regardless of the results from the NORMIMS. This will be the case until the findings of the MECOMBIN study (a similar trial on a larger scale) are made known.

*NORMIMS = nordic trial of oral methylprednisolone as add-on therapy to interferon beta-1a for treatment of relapsing-remitting multiple sclerosis.

"NORdic trial of oral Methylprednisolone as add-on therapy to Interferon beta-1a for treatment of relapsing-remitting Multiple Sclerosis (NORMIMS study): a randomised, placebo-controlled trial"
Per Soelberg Sorensen MD, Svein Ivar Mellgren MD, Anders Svenningsson MD, Irina Elovaara MD, Jette Lautrup Frederiksen MD, Antonie Giaever Beiske MD, Kjell-Morten Myhr MD, Lise Vejby Søgaard PhD, Inge Christoffer Olsen PhD, Magnhild Sandberg-Wollheim MD.
The Lancet Neurology, Early Online Publication, 30 April 2009
doi:10.1016/S1474-4422(09)70085-7
http://www.thelancet.com

Written by Stephanie Brunner (B.A.)
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