Although the biological activity by which Copaxone (glatiramer) exerts its effects i multiple sclerosis (MS) patients is not fully understood, it is believed it can block the induction of autoimmune encephalomyelitis as observed in recent experiments with mice. Research in animals and in vitro systems suggest that glatiramer acetate-specific suppressor T-cells are induced and activated in the periphery.
An ongoing study which combined estriol (estrogen hormone) with Copaxone, a drug used for the treatment of patients with relapsing remitting multiple sclerosis (RRMS), has demonstrated that this combination may improve symptoms for RRMS patients. Findings were presented by Rhonda Voskuhl, M.D., from the University of California, Los Angeles, at the American Academy of Neurology Annual Meeting in Philadelphia.
According to Walter Koroshetz, M.D., deputy director of the National Institute of Neurological Disorders and Stroke (NINDS), “While these results are encouraging, the results of this Phase II study should be considered preliminary as a larger study would be needed to know whether benefits outweigh the risks for persons affected by MS. At present, we cannot recommend estrogen as part of standard therapy for MS. We encourage patients to talk with their doctors before making any changes to their treatment plans.”
MS is an autoimmune disease where immune cells destroy myelin, an insulating fat wrapping, around the axons of neurons in the brain. The loss of myelin brings about movement, balance and cognitive loss as well as pain. Patients with RRMS (the most common form of MS) have relapses (flare-ups) of these neurological symptoms that are followed by recovery times during which symptoms improve.
Previous research suggests that estrogen may have neuroprotective effects and may decrease inflammation, which is a problem in MS. It has been reported that MS patients who are pregnant experience improvement in their symptoms when levels of estrogen increase. However, research into the effects of estrogen therapy in women have presented with mixed results. This study is administering estriol (a derivative of estrogen) which is only produced in the body when a woman is pregnant to determine its potential as a therapeutic agent.
The ongoing two-year trial administered Copaxone along with 8 mg daily of estriol or placebo. The primary goal was to determine if estriol decreased the number of relapses experienced by RRMS patients who were also taking Copaxone. Researchers report at 12 months, estriol and Copaxone treatment was linked with a decrease in relapse rates as compared to Copaxone and placebo. But, at 24 months the difference between therapy groups was not as great as it was at 12 months.
Koroshetz, notes, “The findings presented by Dr. Voskuhl suggest that there may be benefits to supplementing Copaxone therapy with estrogen. A longer study, with more patients, would be necessary to definitively validate these provocative, although early, findings.”