Babies of women with relapsing multiple sclerosis (RMS) who receive daily injections of Copaxone (glatiramer acetate) while pregnant carry the same risk of developing birth defects as babies as a whole, according to a study by the therapy’s developer, Teva Pharmaceutical Industries.
The findings can help doctors counsel and treat women with RMS who become pregnant. The study, “Pregnancy Outcomes From The Branded Glatiramer Acetate Pregnancy Database,” was published in the International Journal of MS Care.
Copaxone is a synthetic protein that simulates the production of myelin, a substance that protects nerve fibers in the brain and spinal cord and that is degraded in MS. The drug also suppresses the immune system by preventing T-cells — a type of immune system cells — from damaging myelin in a process called demyelination.
There have been no well-controlled studies in pregnant women’s use of Copaxone until now.
Tevla decided to investigate whether babies born to MS patients treated with Copaxone while pregnant were at higher risk of having a congenital problem than babies as a whole.
Researchers compared data on babies born to Copaxone-treated MS patients with data on babies born to healthy women.
The 5,025 cases of Copaxone-treated women were in a database containing information on the therapy’s safety, known as the Glatiramer Acetate Pharmacovigilance Database. The two databases of healthy women were the the Metropolitan Atlanta Congenital Defects Program and the European Surveillance of Congenital Anomalies.
Researchers’ analysis showed that the rates of congenital problems in the databases were comparable. This indicated that there was no greater risk of a baby from a Copaxone-treated MS patients having a congenital problem than babies at large.
“Physicians now have this data to consider as they consult with their RMS patients planning a family or already pregnant, to make individual treatment decisions,” Dr. Patricia K. Coyle, the study’s senior author, said in a news release.
“With more than 20 years of data collected on COPAXONE, we are able to share this important analysis with physicians to consider and counsel their patients of child-bearing age,” added Dr. Rob Koremans, president and CEO of Teva Global Specialty Medicines. “We are pleased to put forward this data that may help facilitate that conversation.”