Ustekinumab Is Safe in Pregnancy

Ustekinumab is approved for the treatment of patients with ulcerative colitis, Crohn’s disease, psoriasis, and psoriatic arthritis. Despite its widespread use in these diseases, little is known about its safety in pregnancy. We do know, however, that ustekinumab (an IgG1 monoclonal antibody) is actively transported across the placenta during pregnancy. 

The authors reviewed the Janssen Global Safety Database and analyzed 420 reported pregnancy outcomes in mothers exposed to ustekinumab during pregnancy. There were 340 live births (81%), 51 spontaneous abortions (12.1%), 25 elective/induced abortions (6%), 3 stillbirths (0.7%), and 1 ongoing pregnancy with a fetal congenital anomaly (0.2%). Among the live births, 33 were born preterm (9.7%). These rates are very similar to the reported rates in the general population in the United States. Similar results were seen with paternal exposure to ustekinumab. There did not appear to be any differences in congenital abnormality rates among the different underlying diseases or medication doses.