November 28, 2002
By Adrian Burton
Special to DG News
Interferon beta 1a plus continuous low dose prednisone may dramatically reduce relapse rates in patients with multiple sclerosis (MS).
Worsening of neurological MS symptoms is usually treated with a short-term course of high-dose intravenous glucocorticoids, such as methylprednisolone. However, while this may delay relapses, it does not prevent them, and the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology has recently concluded that there is no evidence of any benefit from short-term glucocorticoid use.
Evidence does exist, however, that a continuous regimen of low-dose prednisone in different combinations with interferon beta 1a and azathioprine can reduce relapse rates by as much as 72 percent. Against this background, Oldrich Kolar, director of the Indiana MS Center, in Indianapolis, Indiana, United States, and colleagues tested a combination therapy. "Our interest was to look for a way [not to lessen the relapse rate], but to stop relapses as safely and as affordably as possible."
In an open label study, Dr. Kolar's group gave 39 men and 149 women, who had relapsing MS and a median age of 45 years, weekly 30-mcg injections of interferon beta 1a and continuous low dose prednisone at a dose of 7.5 to 15 mg/day.
The median duration of the combined therapy was 36 months and patients were followed for four to 71 months.
Patients who experienced a relapse and had an Expanded Disability Status Score (EDSS) increase of 3 or more received additional standard intravenous methylprednisolone for five days, with the total dose not exceeding 3500 mg and a gradual tapering of the prednisone dose from 35 mg/day back to maintenance dose. Those who relapsed but did not exceed an EDSS score increase of more than 3 were treated with a transient increase of the prednisone dose from 0.5 to 1.0 mg/kg for five days up to a maximum of 15 mg/day.
The cohort's annualized relapse rate was less than 0.1. "That's three times lower than with any of the [short term] injection treatments," said Dr. Kolar. The mean EDSS score also fell significantly, from a mean of 2.96 at initiation compared to 2.37 at data processing (p<0.0001).
Though 28 patients had an increase in blood pressure levels and five developed symptoms of diabetes, these were not unmanageable, and no progressive MS disability was registered in any patient, he said.
"People always think daily prednisone treatment will be dangerous, but
we can treat preventively. It's important to understand how steroids work
at the molecular level, and there is an enormous lack of knowledge in this
area," he added.
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