A multicenter, placebo-controlled pilot study of intravenous immune globulin treatment of antiphospholipid syndrome during pregnancy☆,☆☆,★
Section snippets
Methods
We performed a randomized, double-blind, placebo-controlled pilot trial. Women with antiphospholipid antibodies who were at high risk for pregnancy loss were recruited for inclusion in the study at 6 university medical centers through currently existing referral and consultation networks. Women with a single live conceptus who were at ≤12 weeks’ gestation could enroll in the study. Eligibility criteria included the following: (1) the presence of ≥20 immunoglobulin G phospholipid-binding (GPL)
Results
We identified 30 women as candidates for enrollment during the 2-year period from 1995 to 1997. Among these, 14 women were not eligible for enrollment for the following reasons: 3 were not pregnant, 5 declined to enroll, 1 was identified after 12 weeks’ gestation, and 5 did not have appropriate levels of antiphospholipid antibodies when tested in the central laboratory. The remaining 16 women were randomly assigned to receive either intravenous immune globulin (n = 7) or placebo (n = 9). All
Comment
Intravenous immune globulin therapy has been used for the successful treatment of several autoimmune conditions, including Kawasaki disease14 and systemic lupus erythematosus.15 Its mechanism of action is thought to include solubilizing immune complexes or anti-idiotypic down-regulation of autoantibody production. Indeed, Spinnato et al10 showed that immune globulin treatment during pregnancy resulted in a decline in anticardiolipin antibody levels in a group of women with antiphospholipid
Acknowledgements
We thank the Bayer Corporation, West Haven, Conn, for the donation of the Gamimune-N.
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Supported by the Bayer Corporation, West Haven, Connecticut.
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Reprint requests: D. Ware Branch, MD, Rm 2B200, Department of Obstetrics and Gynecology, University of Utah School of Medicine, 50 N Medical Dr, Salt Lake City, UT 84132.
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0002-9378/2000 $12.00 + 06/1/103091