R. Alroughani, B. Kieseier, R. Gouider, M. Benamor, P. Truffinet, L. Henson Pregnancy outcomes in female patients and partners of male patients in the teriflunomide clinical development program
Background/objectives Teriflunomide is a once-daily oral immunomodulator approved for relapsing-remitting multiple sclerosis. Consistent efficacy and safety of teriflunomide were demonstrated in a large clinical trial program. Animal data suggest that teriflunomide may be associated with a risk of teratogenicity. Teriflunomide plasma concentrations <0.02 mg/L in the mother confer minimal risk of teratogenicity, and can be achieved with an accelerated elimination procedure in humans.
Design and methods: Despite the requirement for reliable contraception, pregnancies were reported across the teriflunomide clinical trial program. Upon discovery of pregnancy, patients were instructed to discontinue treatment and undergo an accelerated elimination procedure. Pregnancy outcomes were collected across phase 2 and 3 clinical studies in the teriflunomide clinical development program and available data through October 2013 are reported.
Results: Eighty-three pregnancies were reported in female patients and 22 in partners of male patients; 26 live births occurred in female patients and 16 in partners of male patients receiving teriflunomide. Twenty-nine pregnancies in female patients and two in partners of male patients were terminated electively. Newborns whose parents were exposed to teriflunomide were healthy and had no structural defects or functional deficits at birth. Spontaneous abortion rate (18.6%) was within the range for general population. Median birth weight for 18 newborns was 3.3 kg, and mean gestational age at birth among 23 cases was 39 weeks, all within typical ranges for general population.
Conclusions: Data from the clinical program have shown no teratogenic signals for teriflunomide in humans, consistent with findings of the Organization of Teratology Information Specialists registry and over 2.5 million patient-years of post-marketing data for leflunomide.
Aubagio is a new oral MS drug that is about as effective as the interferons. As part of your drug development process you have to do reproductive toxicity and give the mums (pregnant animals) drug until it is toxic to them and then you see what it does to the unborne. One thing that was found with aubagio was that there appeared to be mutations in the unborn. So it has low activity, birth defect risks and can make your hair thin. However the question occurs what happensin real -life after the phase III trials. In this study they looked at people taking aubagio and said "so far, good news"- the worries of getting pregnant are so far unfounded.
However the advice should be keep to the contraception until we know more, but if a slip-up occurs then this information may help deal with the news and qwell some of the panic.