PMID- 27344079 OWN - NLM STAT- MEDLINE DCOM- 20171204 LR - 20220409 IS - 1778-7254 (Electronic) IS - 1297-319X (Linking) VI - 84 IP - 2 DP - 2017 Mar TI - Pregnancy and foetal outcomes following anti-tumor necrosis factor alpha therapy: A prospective multicentre study. PG - 169-173 LID - S1297-319X(16)30096-3 [pii] LID - 10.1016/j.jbspin.2016.03.014 [doi] AB - 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 (TNFalpha) 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-TNFalpha, disease activity, DMARD therapy, pregnancy/foetal outcomes were registered. RESULTS: Twenty-four/38 (71.1%) pregnancies were exposed to anti-TNFalpha 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-TNFalpha antagonists. No congenital malformations were found in connection to paternal exposure. CONCLUSION: Study results suggest that anti-TNFalpha drugs could be safe when administered during conception/I trimester and following paternal exposure. CI - Copyright (c) 2016 Societe francaise de rhumatologie. Published by Elsevier SAS. All rights reserved. FAU - Hoxha, Ariela AU - Hoxha A AD - Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy. Electronic address: arielahoxha@hotmail.com. FAU - Calligaro, Antonia AU - Calligaro A AD - Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy. FAU - Di Poi, Emma AU - Di Poi E AD - Clinic of Rheumatology, DSMB, University Hospital "Santa Maria della Misericordia", 33100 Udine, Italy. FAU - Peccatori, Susanna AU - Peccatori S AD - Rheumatology Unit, S. Chiara Hospital, 38122 Trento, Italy. FAU - Favaro, Maria AU - Favaro M AD - Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy. FAU - Del Ross, Teresa AU - Del Ross T AD - Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy. FAU - Ramonda, Roberta AU - Ramonda R AD - Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy. FAU - Grava, Chiara AU - Grava C AD - Department of Medicine, S. Martino Hospital, 32100 Belluno, Italy. FAU - Raffeiner, Bernd AU - Raffeiner B AD - Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy. FAU - Ravagni, Paola AU - Ravagni P AD - Rheumatology Unit, S. Chiara Hospital, 38122 Trento, Italy. FAU - De Vita, Salvatore AU - De Vita S AD - Clinic of Rheumatology, DSMB, University Hospital "Santa Maria della Misericordia", 33100 Udine, Italy. FAU - Ruffatti, Amelia AU - Ruffatti A AD - Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani, 2, 35128 Padova, Italy. LA - eng PT - Journal Article PT - Multicenter Study DEP - 20160622 PL - France TA - Joint Bone Spine JT - Joint bone spine JID - 100938016 RN - 0 (Antirheumatic Agents) RN - 0 (Tumor Necrosis Factor-alpha) SB - IM MH - Adult MH - Antirheumatic Agents/*therapeutic use MH - Arthritis, Rheumatoid/*drug therapy MH - Female MH - Fetal Diseases/chemically induced MH - Humans MH - Middle Aged MH - Pregnancy MH - Pregnancy Outcome MH - Prospective Studies MH - Spondylarthropathies/*drug therapy MH - Tumor Necrosis Factor-alpha/*antagonists & inhibitors OTO - NOTNLM OT - Ankylosing spondylitis OT - Anti-TNFalpha agents OT - Foetal outcome OT - Pregnancy OT - Psoriatic arthritis OT - Rheumatoid arthritis EDAT- 2016/06/28 06:00 MHDA- 2017/12/05 06:00 CRDT- 2016/06/27 06:00 PHST- 2015/11/10 00:00 [received] PHST- 2016/03/24 00:00 [accepted] PHST- 2016/06/28 06:00 [pubmed] PHST- 2017/12/05 06:00 [medline] PHST- 2016/06/27 06:00 [entrez] AID - S1297-319X(16)30096-3 [pii] AID - 10.1016/j.jbspin.2016.03.014 [doi] PST - ppublish SO - Joint Bone Spine. 2017 Mar;84(2):169-173. doi: 10.1016/j.jbspin.2016.03.014. Epub 2016 Jun 22.