Teriflunomide (Aubagio) is a once daily oral disease modifying therapy approved for treating patients with relapsing forms of multiple sclerosis (MS). One of the limitations of its use is its black box warning for potential fetal harm due to birth defects noted in rats and rabbits. Women who are of childbearing age who are not using reliable birth control are advised to not use teriflunomide.
At the Consortium of Multiple Sclerosis Centers annual meeting on May 30, I presented a poster describing 81 pregnancies in female patients and 20 pregnancies in partners of male patients in nine teriflunomide clinical studies. Of these pregnancies, none of the 20 babies born to female patients and 12 live births in partners of male patients had any structural or functional problems. The mean known birth weight and mean gestational age were normal, as was the miscarriage rate.
These findings are consistent with the findings from the pregnancy registry associated with leflunomide, a drug used for rheumatoid arthritis since 1998 and which becomes metabolized to teriflunomide as the active drug. It suggests that teriflunomide may be safe for patients with relapsing multiple sclerosis who are using reliable birth control.
For more, read the full abstract reported at the 2013 Consortium of MS Centers.