Joint bone spine · 2016
Pregnancy and foetal outcomes following anti-tumor necrosis factor alpha therapy: A prospective multicentre study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Hoxha Ariela, Calligaro Antonia, Di Poi Emma, Peccatori Susanna, Favaro Maria, Del Ross Teresa, Ramonda Roberta, Grava Chiara, Raffeiner Bernd, Ravagni Paola, De Vita Salvatore, Ruffatti Amelia
Аннотация
OBJECTIVE: As many inflammatory rheumatic diseases affect patients in childbearing age, some concern has been expressed about the safety of biologic drugs during pregnancy. This study evaluated the effects of anti-tumor necrosis factor alpha (TNFα) agents on pregnancy/foetal outcomes.
METHODS: Thirty-eight pregnancies were followed prospectively from November 2008 to February 2015. Information about the patients' exposure to anti-TNFα, disease activity, DMARD therapy, pregnancy/foetal outcomes were registered.
RESULTS: Twenty-four/38 (71.1%) pregnancies were exposed to anti-TNFα at conception/I trimester, 11/38 (28.9%) prior to conception and 3 (11.1%) following paternal exposure. There were two congenital malformations: one infant (4.2%) was diagnosed with congenital diaphragmatic hernia and obstructive megaureter; the mother was exposed to adalimumab at conception/I trimester. While one foetus (9.1%) showed a trisomy 16, the mother 38 year-old had suspended etanercept 4 weeks before conception. There was no significant difference in pregnancy/foetal outcome between the two groups. Nor were there any significant differences in pregnancy/foetal outcomes in the various groups being treated with different anti-TNFα antagonists. No congenital malformations were found in connection to paternal exposure.
CONCLUSION: Study results suggest that anti-TNFα drugs could be safe when administered during conception/I trimester and following paternal exposure.
METHODS: Thirty-eight pregnancies were followed prospectively from November 2008 to February 2015. Information about the patients' exposure to anti-TNFα, disease activity, DMARD therapy, pregnancy/foetal outcomes were registered.
RESULTS: Twenty-four/38 (71.1%) pregnancies were exposed to anti-TNFα at conception/I trimester, 11/38 (28.9%) prior to conception and 3 (11.1%) following paternal exposure. There were two congenital malformations: one infant (4.2%) was diagnosed with congenital diaphragmatic hernia and obstructive megaureter; the mother was exposed to adalimumab at conception/I trimester. While one foetus (9.1%) showed a trisomy 16, the mother 38 year-old had suspended etanercept 4 weeks before conception. There was no significant difference in pregnancy/foetal outcome between the two groups. Nor were there any significant differences in pregnancy/foetal outcomes in the various groups being treated with different anti-TNFα antagonists. No congenital malformations were found in connection to paternal exposure.
CONCLUSION: Study results suggest that anti-TNFα drugs could be safe when administered during conception/I trimester and following paternal exposure.