In the etanercept group, major defects were seen in 9.4% of all pregnancies in the etanercept group and in 4.5% of the control group. Pregnancies resulted in live births in 94% of the etanercept group and 88% of the control group (due to a higher rate of spontaneous abortion in the control group).
Among live births, 8.5% in the etanercept group had major defects, compared with 1.7% of the control group, reported Dr. Diana L. Johnson of the University of California, San Diego, and her associates.
The two groups did not differ significantly in mean birth weight of full-term infants, mean gestational age at delivery of live births, or pregnancy terminations.
The women took etanercept to treat rheumatoid arthritis; psoriasis or psoriatic arthritis; ankylosing spondylitis; or multiple diseases.
The project is sponsored in part by grants from 10 pharmaceutical companies including Amgen Inc., which markets etanercept with Wyeth Pharmaceuticals.
▸ Adalimumab. The OTIS Autoimmune Diseases in Pregnancy Project also followed 33 women who took adalimumab for rheumatoid arthritis during the first trimester of pregnancy and followed them in the same manner as the etanercept cohort. Their birth outcomes were compared with birth outcomes of 52 pregnant women with the same disease but no adalimumab treatment and 45 pregnant women without rheumatoid arthritis.
Preliminary data from the ongoing study suggest that rates of spontaneous abortion, stillbirth, congenital defects, and preterm deliveries are similar between groups and within the expected range in the general population, Dr. Johnson and her associates reported in a separate poster. A larger sample size is needed, however, to draw firm conclusions, she added.
The companies that fund the project include Abbott Laboratories, which markets adalimumab.
▸ Systemic sclerosis. Worsening of systemic sclerosis and progression to organ problems in three out of five Hungarian women after pregnancy surprised investigators in a separate study. Previous reports identified a higher risk for maternal scleroderma renal crisis in the third trimester, but other than that have suggested that disease symptoms generally do not change or may improve during pregnancy.
The five pregnancies among 400 women with systemic sclerosis who were seen at two medical centers from 1995 to 2007 resulted in five infants with no severe organ complications, reported Dr. G. Szucs of the University of Debrecen (Hungary), and associates.
One mother with limited cutaneous disease had a normal, full-term delivery. One with diffuse cutaneous disease had a spontaneous preterm birth. Three women (one with limited cutaneous disease and two with diffuse systemic sclerosis) were delivered by C-section because of maternal hypertension and proteinuria with a high risk for renal crisis.
The hypertension and proteinuria disappeared after C-section delivery in one woman with diffuse disease, who was treated with an ACE inhibitor to avert renal crisis.
Three other women (one with limited disease and two with diffuse disease) developed severe manifestations of systemic sclerosis after delivery—fibrosing alveolitis; cardiomyopathy with arrhythmias or cardiac failure; renal failure; and/or rapidly progressing skin symptoms.
Pregnant women with systemic sclerosis “should be monitored often and carefully after delivery for not only renal but other life-threatening complications,” Dr. Szucs suggested.