The Safety Profile of Teriflunomide for Multiple Sclerosis Treatment

It’s important, Aaron Miller, MD Professor of Neurology and Medical Director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai Hospital in New York said, to also look at the safety profile of the drug — these safety data in the TOPIC extension trial were very comparable to those that were seen in the pivotal phase 3 relapsing remitting trials.“These are generally very mild, and principally occur early in the course of treatment.”

· A small percent experienced hair thinning that caused them to drop out of the trial. But, those who experienced this is the rest of the group typically saw virtually no reports of hair thinning 6-12 months after beginning the drug treatment.

· A small percent had elevations of transaminases. Though usually mild, it’s important for people to remember that the US prescribing info recommends monthly liver function tests for the first 6 months.

· The third side effect worth mentioning are generally mild GI symptoms that mostly consist of diarrhea. They are more common earlier on, but some physicians do see an occasional patient who continues to experience diarrhea as he or she continues on the drug therapy.

According to Miller, there was one other aspect of data reported in the poster about the effect on lymphocyte counts. Low lymphocyte counts are often a concern with some medications in multiple sclerosis; however, the mean lymphocyte counts stayed up in the normal range throughout treatment with teriflunomide and virtually no patients have a severe drop in lymphocyte counts.

“This appears to be a very safe and effective drug, and is a valuable part of our therapeutic armamentarium. I don’t think teriflunomide addresses all the unmet needs in MS, in fact, no drug meets all the unmet needs, but this is a very well tolerated oral agent.” Miller said.