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Estriol/Copaxone Reduces Relapse in Women With MS

Mid-stage trial shows efficacy over 1 year

Positive results have been reported from a phase II study that evaluated the sex hormone estriol (Trimesta, Synthetic Biologics), in combination with Copaxone (glatiramer acetate, Teva Neuroscience), in women with relapsing-remitting multiple sclerosis (RRMS). According to the authors, the new findings invite further study of estriol as a potential approach for treating women with MS.

The study was funded by the National MS Society, by additional private donors, and by the National Institute of Neurological Disorders and Stroke.

The findings were presented April 29 at the American Academy of Neurology’s annual meeting in Philadelphia, Pennsylvania.

MS is a potentially disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis. Most people with MS are diagnosed between the ages of 20 and 50, and at least two to three times more women than men have the disease.

Estriol levels rise significantly during later pregnancy — a time when many women’s MS disease activity declines. This led some researchers to suspect that estriol may be responsible for the easing of MS symptoms during pregnancy.

In the new study, investigators recruited 164 women aged 18 to 50 years with RRMS at sites across the U.S. All of the participants were receiving standard Copaxone therapy (daily subcutaneous injections) and were randomly assigned to additional treatment with estriol in pill form or placebo for 2 years.

The study’s primary outcome measure was the effects of the treatment combination on relapse rates. Secondary outcomes included several clinical and magnetic resonance imaging (MRI) measures of disability progression and cognitive function. In addition, laboratory and gynecologic tests monitored potential safety issues associated with the use of estriol and other estrogen hormones, including breast and endometrial (uterine) cancers.

Preliminary results showed that the combination of Copaxone and estriol appeared to be safe over the 2-year treatment period. No severe adverse events were experienced by patients in either treatment group.

After the first year of the study, patients receiving combined therapy (Copaxone and estriol) experienced a significant reduction in relapse rates compared with those receiving Copaxone and placebo, and secondary cognitive testing suggested a possible benefit for those in the combination-treatment group. However, after the second year of the study, there were no statistical differences in relapse rates between those treated with Copaxone and estriol versus those treated with Copaxone and placebo.

Estriol is one of several estrogen sex hormones in the body. Some forms of estrogen are available for prescription as methods of birth control and for the treatment of symptoms associated with menopause. The oral form of estriol used in this trial is not available in the U.S.

Source: National MS Society; April 29, 2014.

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