Development in the cynomolgus macaque following administration of ustekinumab, a human anti‐il‐12/23p40 monoclonal antibody, during pregnancy and lactation

Abstract

Exposure of macaque fetuses and infants to ustekinumab had no adverse effects on pre- and postnatal development.

Ustekinumab in treatment of Crohn’s disease: design, development, and potential place in therapy

“…Ustekinumab is a US FDA class B medication, primarily based on animal studies in cynomolgus monkeys and with limited human data 6,59,60. Evaluation of the 29 pregnancies reported with maternal use of ustekinumab (at least 1 dose) from 4 psoriasis studies demonstrated no congenital anomalies, a rate of spontaneous abortion comparable to the general population (15%–20%), and no association between a longer duration of ustekinumab exposure before the reported pregnancy and adverse outcomes 61.…”

Pregnancy during Ustekinumab Treatment for Severe Psoriasis

“…The administration of high doses of ustekinumab to cynomolgus monkeys during pregnancy and lactation had no adverse effects on females or fetuses. In this animal model, abortion rates were the same with and without exposure to the drug [12]. According to medication characteristics, it is preferable to avoid ustekinumab during pregnancy, and women of childbearing age should use effective contraception during and up to 15 weeks after treatment [13].…”

Treating Psoriasis During Pregnancy: Safety and Efficacy of Treatments

“…Two fetal development studies of ustekinumab conducted in cynomolgus macaques have revealed no evidence of maternal toxicity, embryotoxicity, or teratogenicity [107]. There are very limited data on the safety of ustekinumab treatment during pregnancy.…”