Monthly methylprednisolone in combination with interferon beta or glatiramer acetate for relapsing-remitting multiple sclerosis: A multicentre, single-blind, prospective trial.

OBJECTIVES

Multiple sclerosis is usually clinically characterized by repeated subacute relapses followed by remissions. Corticosteroids are used for relapses, and this treatment has been shown to increase the speed of recovery from these. We aimed to evaluate the efficacy and safety of pulsed methylprednisolone given every month as an add-on therapy to interferon beta or glatiramer acetate in patients with relapsing-remitting multiple sclerosis.

PATIENTS AND METHODS

This was a multi-center, examiner-blinded, prospective study. Absolute annualized relapse rates and Expanded Disability Status Scale scores were calculated.

RESULTS

103 patients were given intravenous methylprednisolone (1 dose of 1g IV) once a month for 12 months as add-on therapy and were assessed during this period. The decrease in the absolute annualized relapse rate was 0.69, and 72 patients were relapse-free at the end of the year. Sixty-nine of the 103 patients had the same Expanded Disability Status Scale scores at the end of one year, while 21 were less disabled, and 13 sustained disability progression. Health related quality of life measured using the MS Quality of Life scale improved significantly during the study period.

CONCLUSION

The addition of monthly pulsed methylprednisolone to subcutaneous interferon beta or glatiramer acetate therapy significantly reduced the relapse rate and may also be beneficial in terms of disease progression. These combinations were also safe, and most patients tolerated methylprednisolone as an add-on to interferon beta or glatiramer acetate.