Anti-TNF Has Low Risk of Congenital Malformation

VBCR - August 2015, Volume 4, No 4 - In the News

Exposure to biologics around the time of conception does not appear to have negative effects on neonates, according to data from the German biologics RABBIT (Rheumatoid Arthritis Observation of Biologic Therapy) registry. Although there are extensive data on the safety of biologic DMARDs, concerns remain about giving the drugs to pregnant women because of the potential adverse effects on offspring.

The registry included 106 pregnancies in 89 women aged ≤45 years occurring between 2001 and 2014; of these pregnancies, 42 occurred between 2011 and 2014. Thirty-eight women had stopped biologics prior to conception, 57 were exposed to biologics at conception, and 11 were biologic naive at conception.

The women who discontinued biologics prior to conception had been treated with rituximab (n = 13), etanercept (n = 12), adalimumab (n = 9), toci­liz­umab (n = 2), and infliximab (n = 2). The most common biologics received by women at conception were etanercept (n = 29) and adalimumab (n = 11).

Five spontaneous abortions occurred in 38 (13%) pregnancies during which biologics had been stopped at least 4 weeks prior to conception, and 11 spontaneous abortions were reported among 57 (19%) pregnancies exposed to biologics at conception.

The investigators, led by senior author Angela Zink, MD, German Rheumatism Research Center, Berlin, noted that these rates of spontaneous abortion were similar to those found in the general population.

Induced abortions were performed in 4 pregnancies: 3 in the 38 women who stopped biologics prior to conception and the fourth in a woman who was on a biologic at conception.

The rate of live births was 100% for biologic-naive women, 79% for those who stopped biologics at conception, and 79% for those who were taking biologics at conception.

Congenital defects were observed in 3 infants born to mothers who stopped biologics and 1 infant whose mother was on a biologic at conception.

Remission during pregnancy was rarely observed in patients with long-standing RA. Of note, a proportion of patients had increased disease activity during pregnancy, contrary to other observational studies in which pregnancy has been found to reduce disease activity.

Of 23 patients in remission prior to baseline, 10 (43%) remained in remission during pregnancy, whereas only 7 (14%) of 49 patients not in remission prior to pregnancy achieved remission during pregnancy. Strangfeld A, et al. Presented at: 16th Annual European Congress of Rheumatology. Abstract OP0017.

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