Multiple Sclerosis and Pregnancy: New Research on Estriol

It’s been recognized for a long time – almost as long as Multiple Sclerosis has been known –that when women who have MS are pregnant, they feel much better. In fact, women feel so much better it has often been said it’s too bad we can’t just remain in a pregnant state to keep our symptoms at bay because pregnancy seems to put MS into remission for the vast majority of women.

Like me, you may be wondering if it has been common knowledge that women with MS during pregnancy almost always go into remission, why haven’t we studied this sooner? That answer lies in the need to find a form of the beneficial pregnancy estrogen, estriol, that can be produced in a lab for human use and meet the safety concerns - it appears we may be getting closer to that point.

The recent annual gathering for the American Academy of Neurology (AAN) heard presentations on many different types of research being done for MS treatment and myelin repair, including researchers sharing their findings on the Phase II trial of combining Copaxone with a synthetic version of Estriol (Trimesta, manufactured by Synthetic Biologics). Estriol is the estrogen hormone that naturally occurs in pregnancy – it is produced via the placenta and is found in especially elevated levels in the second half of pregnancy.

The study, A Combination Trial of Estriol Plus Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis, was presented by Rhonda Voskuhl, M.D., the Lead Investigator from UCLA, as part of AAN’s emerging science programs.1

In this study, all of the participants were placed on glatiramer acetate (Copaxone). The group was then randomized and the participants were given either a placebo or 8mg of estriol, to be taken with their Copaxone. After one year in the study, the women who had received the estriol plus the Copaxone had a significant (47%) reduction in relapses compared to the women who had the placebo with their Copaxone.

The relapse rate favoring the combined therapy changed for the second year of the study, with women taking estriol and Copaxone showing a 32% reduction relapse rate over the placebo treatment. While the percentage decreased, it was still a significant improvement in relapse rate over using just Copaxone and the placebo.

Researchers also found that using both estriol and Copaxone in this way had a positive effect on cognitive function, and there was measurable improvement using several different assessment tools. The improvements in cognition remained steady through the 24-month trial period.

Estriol is just one of many different forms of estrogen produced in our bodies and can now be reproduced in pharmaceutical labs. Estrogen is found in birth control pills and also used in hormone replacement treatments but those work in the body in a different way than estriol. There are health concerns about the use of high levels of estrogen, including increased risk of breast and uterine cancer, dementia and stroke, but those risks don’t appear to extend to estriol. The study with estriol did not show any increases in the health problems, but because of these concerns, adding any type of estrogen as part of MS drug therapy is not recommended or approved until further studies are completed to validate these results.

This study was done with 164 women with Relapsing Remitting Multiple Sclerosis (RRMS) between the ages of 18 and 50 enrolled initially; 116 women in total completed the two year study. The cost of the trial was supported primarily by the National Multiple Sclerosis Society, the Southern California chapter of NMSS, and the National Institutes of Health.

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