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Type: Conference item
Title: Intra-uterine exposure to anti-TNF-alpha therapy (ERA study): Neonatal levels of TNF antibodies correlate with duration of therapy in pregnancy
Author: Julsgaard, M.
Christensen, L.A.
Gearry, R.
Andrews, J.M.
Rosella, O.
Connor, S.
Walsh, A.J.
Brown, S.
Connell, W.
Gibson, P.
Bell, S.J.
Citation: Journal of Gastroenterology and Hepatology, 2013, vol.28, iss.Suppl. 2, pp.85-85
Publisher: Wiley
Issue Date: 2013
ISSN: 1440-1746
Conference Name: Australian Gastroenterology Week (AGW) (7 Oct 2013 - 9 Oct 2013 : Melbourne, Australia)
Statement of
M Julsgaard, LA Christensen, R Gearry, J Andrews, O Rosella, S Connor, A Walsh, S Brown, W Connell, P Gibson, SJ Bell
Abstract: Background: Recent studies suggest no adverse pregnancy outcomes in babies exposed to anti TNF antibodies (ATA), however the long term implications are unknown. Current guidelines recommend cessation of treatment in the last trimester of pregnancy to reduce foetal exposure but this is difficult for women who are not in deep remission. Measurement of ATA levels is becoming available and may guide decision making. Aims: To determine drug levels of ATA in cord blood of babies exposed to ATA in pregnancy; and to correlate this with maternal levels, the duration of therapy in pregnancy, and time to clearance of ATA in infants. Methods: ATA levels were measured by ELISA in cord and maternal blood at delivery (Therapeutic range 3–7μg/ml). If positive at birth, babies were tested at 3, 6, 9 and 12 months. Demographics, disease phenotype, duration of anti TNF use in pregnancy, medication and pregnancy out-comes were collected by questionnaire and from the treating doctor. Results: To date 20 women have been recruited. 11 mother-baby pairs have been tested (5 on infliximab, 7 on adalimumab). Drug was ceased prior to the third trimester in 4. There was an inverse correlation between time since last exposure, and neonatal and maternal ATA levels at birth(r2=0.2 and 0.3 respectively). There was no difference between the two drugs. Mothers who stopped prior to week 30 had undetectable or very low levels. Babies whose mothers stopped treatment prior to week 30 had levels below 3 g/ml. Two babies of seven exposed in the last trimester had levels above 7μg/ml (10, 12). Three babies tested to date at 3 months had near undetectable levels but had not completely cleared. Conclusions: ATA levels in the neonate inversely correlate with the time since last exposure. Cessation of ATA prior to week 30 results in low levels in the neonate and early clearance and is a good option for women in deep remission. Follow up will determine whether high neonatal levels have any negative consequences. Recruitment is ongoing.
Rights: © 2013 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd
DOI: 10.1111/jgh.12365_6
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