LIVERPOOL, ENGLAND – Hydroxychloroquine was not associated with any adverse long-term complications in the children of women with systemic lupus erythematosus who used the drug during pregnancy or while breastfeeding in a multicenter, cross-sectional survey.
In fact the research, recently reported at the British Society for Rheumatology annual conference, showed that the disease-modifying antirheumatic drug (DMARD) reduced exposed children’s risk of admission to hospital for infection (14% vs. 24.8% for nonexposed children; P = .03) and the need for outpatient visits (12.6% vs. 23.1%; P = .0.03).
There was no significant increased risk for congenital anomalies (2.1% vs. 2.2%), including congenital heart block (2.0% vs. 2.9%), or developmental problems such as attention-deficit hyperactivity disorder (0% vs. 2.9% for ADHD). Mothers who used the DMARD were also no more at risk of developing eclampsia during their pregnancy than those who did not (11% vs. 9%; P = .75).
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Hydroxychloroquine use did not have any long-term complications during pregnancy and breastfeeding, investigators said.
"Hydroxychloroquine should be continued during pregnancy and breastfeeding," advised study investigator Dr. Mary Gayed of the department of rheumatology at the University of Birmingham (England).
Dr. Gayed, who presented the study findings on behalf of the British Isles Lupus Assessment Group (BILAG), said that these were hopefully reassuring findings. "We know that immunosuppressive agents, including hydroxychloroquine, are used in SLE [systemic lupus erythematosus] during pregnancy to prevent disease flare and to ensure optimum outcomes for both mother and child," she said, explaining the rationale behind the research, "but there are few published data regarding the long-term outcome of these children."
Randomized, controlled study data have shown that women who continue treatment with hydroxychloroquine during their pregnancy exhibit no disease activity and require only low doses of steroids by the end of their pregnancy, Dr. Gayed observed. This has been corroborated by other studies that have shown that discontinuing the DMARD leads to higher disease activity and the need for higher steroid doses.
Lack of good disease control during pregnancy is linked to maternal complications such as high blood pressure, proteinuria, thrombocytopenia, and secondary antiphospholipid syndrome. "We also know that women who have active lupus during pregnancy have a reduced rate of live births, earlier deliveries, increased pregnancy losses, and increased small-for-gestational-age babies, which makes it key to control disease activity throughout pregnancy," said Dr. Gayed.
Dr. Gayed and associates have previously reported their findings on the long-term out comes of all DMARDs used to treat SLE in pregnancy and will release further data from their survey on the safety of azathioprine at the upcoming European League Against Rheumatism Congress next month in Paris. The current research question was to look at their data specifically with regard to hydroxychloroquine and how this affected maternal, neonatal, and childhood outcomes.
Their retrospective survey involved 200 women with SLE, defined using American College of Rheumatology criteria, who gave birth to a total of 287 children. Of these, 118 women used the DMARD during their pregnancy or while breastfeeding, with 149 children exposed to hydroxychloroquine during the neonatal or postnatal periods. The majority of women (n = 76) used the drug during pregnancy and breastfeeding, 42 during pregnancy only, and 4 only while they were breastfeeding. There were 102 women who did not use the drug during pregnancy or breastfeeding and who gave birth to 138 nonexposed children.
At the birth of their children, the mean age of mothers was 32 years, and they had a mean disease duration of 7.5 years overall, with a mean maternal disease duration of 6.5 years versus 8.6 years comparing the hydroxychloroquine-exposed with the nonexposed children. The majority (66%) of the women were white, 15% were South Asian, 10% Afro-Caribbean, 1% Chinese, 1% Hispanic, and the remainder of other or unstated ethnicity. There was no significant difference in the use of azathioprine, aspirin, or heparin, but mothers who used hydroxychloroquine were significantly more likely to use steroids than women who did not use the DMARD (66% vs. 51%; P = .02).
The median gestational age at delivery was 38 weeks in both hydroxychloroquine-exposed and nonexposed children. There was no statistical difference in birth weight between the groups, which was a mean of 2.8 kg in both exposed and nonexposed children. The median age of children exposed to hydroxychloroquine at enrollment was 2.1 years versus 4.6 years for nonexposed children.
The findings are limited by the fact that these are self-reported data, and it was not always possible to check medical records, Dr. Gayed said. Data on disease activity and prednisolone dose were also not available. That said, "this U.K. cross-sectional survey highlights that hydroxychloroquine is compatible with pregnancy," Dr. Gayed concluded.