“Live births were reported for the majority of pregnancies of women with rheumatic diseases following maternal certolizumab exposure,” Dr. Cush said.
Almost three-quarters (73.1%) of the 78 women with rheumatic disease had a live birth with no congenital malformations. Around 5% of live births were associated with congenital malformations, and the rates of spontaneous and induced abortions were a respective 11.5% and 14.1%.
In the 132 women with nonrheumatic inflammatory diseases, there were 86.6% live births without and 4.4% with congenital abnormalities and 9.1% and 5.3% spontaneous and induced abortions.
For all indications, there were 12 congenital malformations from 254 live births. These included anal fistula, polydactyl left hand, posterior ankyloglossia, renal cyst for which no treatment was needed, pyloric stenosis, club foot, and left-sided vesicoureteral reflux.
Dr. Cush noted that one neonate in a set of premature twins delivered at 26 weeks died due to brain damage and pneumoperitoneum.
Importantly, the data were “encouraging” he said and “suggest that certolizumab exposure in utero, including the first trimester of exposure, does not adversely affect pregnancy outcome.”
The German biologics registry RABBIT is supported by grants from AbbVie, BMS, Celltrion, Hospira, MSD, Pfizer, Roche, and UCB. Dr. Strangfeld reported having no disclosures. Dr. Zink has received speaker fees from AbbVie, BMS, MSD, Pfizer, Sanofi Aventis, Roche and USB. Dr. Cush disclosed receiving research grants from Pfizer, Celgene, CORRONA, Amgen, the National Institutes of Health, Novartis, and UCB.
*Correction, 6/24/2015: An earlier version of this article contained a misspelled word in the headline.