Publications

RA and psoriasis may present in women of child-bearing potential, however there are currently no adequate or well-controlled studies of tofacitinib (TOF) or any DMARD in pregnant women. Pregnancy was an exclusion criterion of TOF randomized clinical trials because of the unknown effects of TOF on mother and child; TOF is a small molecule with the potential to cross the placenta. The current analysis looked at reported pregnancies and their outcomes from TOF RA and psoriasis clinical safety databases up to April 2014 (N=9815), including patients receiving TOF monotherapy and TOF + MTX combination therapy. Pregnancy outcomes were analyzed from patients who received TOF at the time of conception and/or during the course of pregnancy, and cases of identified paternal exposure to TOF. Outcomes were categorized as: healthy newborn, medical termination, fetal death (death after 20 weeks’ gestation), congenital malformation, spontaneous abortion, or pending/lost to follow-up. Only a small number of pregnancies were identified: 31 in RA patients; 16 in psoriasis patients. Of these, 16 (51.6%) and 9 (56.3%) were healthy newborns, respectively. Two of the three cases of paternal exposure to TOF in RA trials were healthy newborns, the third a spontaneous abortion (TOF + MTX combination therapy); approximately half of the 41 cases of paternal exposure to TOF in psoriasis trials were healthy newborns.Although no clear cut associations can be made, based on the limited clinical data reported, unintentional exposure to TOF during conception/pregnancy does not appear to increase the risk to the fetus.