Ariela Hoxha1, Antonia Calligaro2, Emma Di Poi3, Susanna Peccatori4, Maria Favaro2, Teresa Del Ross2, Roberta Ramonda2, Chiara Grava5, Bernd Raffeiner2, Paola Ravagni4, Salvatore De Vita3, Amelia Ruffatti2. 1. Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy. Electronic address: arielahoxha@hotmail.com. 2. Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy. 3. Clinic of Rheumatology, DSMB, University Hospital "Santa Maria della Misericordia", 33100 Udine, Italy. 4. Rheumatology Unit, S. Chiara Hospital, 38122 Trento, Italy. 5. Department of Medicine, S. Martino Hospital, 32100 Belluno, Italy.
Abstract
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.
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-tumornecrosis 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.
Authors: Megan E B Clowse; Angela E Scheuerle; Christina Chambers; Anita Afzali; Alexa B Kimball; John J Cush; Maureen Cooney; Laura Shaughnessy; Mark Vanderkelen; Frauke Förger Journal: Arthritis Rheumatol Date: 2018-07-22 Impact factor: 10.995
Authors: L F Perez-Garcia; R J E M Dolhain; S Vorstenbosch; W Bramer; E van Puijenbroek; J M W Hazes; B Te Winkel Journal: Hum Reprod Update Date: 2020-11-01 Impact factor: 15.610