Early Data Suggest Infliximab is Safe in Pregnancy.

ATLANTA -- Information is emerging about the effect of infliximab in pregnancy, and the initial results indicate no higher risk of miscarriage or birth defects, Dr. Jeffry A. Katz said at the annual Digestive Disease Week.

This is the first information available on human exposures to infliximab during pregnancy according to Centocor Inc.--makers of Remicade (infliximab)--researchers at Case Western Reserve University in Cleveland, and other investigators.

Prior to approval of the monoclonal antibody by the Food and Drug Administration for treating patients with Crohn's disease and rheumatoid arthritis, studies in a mouse model showed no evidence of maternal toxicity, embryotoxicity, or teratogenicity.

Among 42 pregnancies identified in women who had Crohn's disease or rheumatoid arthritis and were treated with infliximab, follow-up information was available for 35 women.

The incidences of live births, miscarriages, and therapeutic terminations were consistent with those observed in a national cohort of healthy women, according to Dr. Katz, of Case Western Reserve University.

Exact dates of drug exposure were documented for 20 of the 35 women studied.

The remaining 15 were simply identified as having received, infliximab. The authors of the study noted that the data should be viewed in light of the fact that, in Crohn's disease and rheumatoid arthritis, disease activity is already associated with the risk of fetal complications.