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Wednesday

 

Old Drug Has New Promise in MS























Minocycline, an inexpensive oral therapy with a proven safety record, may have a new role to treat patients with possible multiple sclerosis (MS), a new study suggests.

The antibiotic has been around for 40 years and is better known as a treatment for infections and severe acne, but a new study showed that after 6 months of treatment, minocycline reduced the absolute risk of developing MS by 27.4%, and the relative risk by 44.6%, compared with placebo in patients with clinically isolated syndrome.

"This is comparable with the efficacy of other approved therapies," said lead author, Luanne Metz, MD, professor and head, Division of Neuroscience, Department of Clinical Neurosciences, University of Calgary, Alberta, Canada.

She added that this is the first phase 3 trial to demonstrate a benefit for an antibiotic in MS. Not only does minocycline require no safety monitoring, but giving it to patients involves "a simple prescription" that doesn't require "complex paperwork," she said.

The findings were presented here at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2015.

Multiple Immune Effects

Although minocycline is an antibiotic, it has multiple immune-modulating effects, including preventing leukocytes from crossing the blood-brain barrier, and inhibition of microglia, a mechanism that might be important in MS, said Dr Metz.

Previous research suggested that minocycline might actually modulate disease activity in MS, as a monotherapy or as an add-on treatment.

The new study included adult patients at 12 centers across Canada who had their first clinical demyelinating event within the previous 180 days and had at least two T2 hyperintense lesions on brain MRI.

Researchers randomly assigned participants to placebo or to 100 mg of generic minocycline twice daily. According to Dr Metz, this is the standard dose used to treat an infection or for long-term acne therapy.

Participants continued receiving the assigned therapy for up to 24 months or until they had changes that indicated they had MS.

The two groups were similar at baseline except that more patients in the placebo group had a spinal cord site of onset (P = .04), which is a predictor of an earlier switch to MS, said Dr Metz. As well, more patients in the placebo group had two or more gadolinium-enhancing lesions. "That was one factor, along with spinal cord site, that could bias in favor of the drug."

Cranial MRI was done at baseline and at regular intervals for 24 months. Participants were contacted by phone throughout the study, "so we were in touch with patients at least every 3 months," said Dr Metz.

The MRI scans were interpreted by the same blinded independent reader at the University of British Columbia in Vancouver.

The primary outcome was the proportion of patients who had a relapse or MRI changes that would confirm they had definite MS (as determined by the McDonald criteria of 2005) at 6 months.

Of the 143 patients who were randomly assigned, 1 was assigned in error because the criteria were not met. At 6 months, 9 patients had withdrawn from the study in the minocycline group (3 because of drug intolerance) and 4 in the placebo group had withdrawn. By the end of 24 months, 18 had withdrawn in the minocycline group compared with 6 in placebo group.

Story Source: The above story is based on materials provided by MEDSCAPE
Note: Materials may be edited for content and length

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