Original ResearchFull Report: Clinical—Alimentary TractConcentrations of Adalimumab and Infliximab in Mothers and Newborns, and Effects on Infection
Section snippets
Materials and Methods
Pregnant women with IBD who received treatment with adalimumab (Humira, AbbVie, North Chicago, IL) or infliximab (Remicade, MSD, Kenilworth, NJ) were recruited prospectively from 14 tertiary hospitals in Denmark, Australia, and New Zealand from March 2012 to November 2014. Multiple pregnancies were excluded because they were associated with an increased risk of adverse outcomes.13 If a woman gave birth more than once during the study period (n = 2), both pregnancies were included.
All eligible
Mother–Baby Pairs
Of the 89 pregnant women recruited, 5 (6%) miscarried before GW 10 and 4 (4%) failed blood collection (samples were not correctly prepared or transported), leaving 80 mother–baby pairs for analysis: 42 from Denmark, 29 from Australia, and 9 from New Zealand. Demographic and clinical details are shown in Table 1.
Medical Therapy During Pregnancy
Thirty-six (45%) women received adalimumab and 44 (55%) received infliximab. The majority (90%) received standard-dose treatment (ie, adalimumab 40 mg every other week or infliximab 5
Discussion
This international multicenter study comprehensively examined the outcomes of fetal exposure to the 2 complete IgG1 antibodies, adalimumab and infliximab, in infants born of women with IBD. It provides novel data in a well-characterized prospective cohort representative of clinical practice, showing that postnatal clearance of anti-TNF is prolonged, particularly of infliximab. The study provides a solid evidence-based rationale for the counseling and management of pregnant women and infants
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Conflicts of interest These authors disclose the following: Lisbet Christensen has served on the advisory boards of AbbVie and MSD, and has received speaker’s fee from MSD, Ferring, UCB, Takeda, Tillotts, and AbbVie; Peter Gibson has served on the advisory boards of AbbVie, Ferring, Janssen, Merck, Nestle Health Science, Danone, Allergan, and Takeda, has received consultation fees from AbbVie, Ferring, Janssen, Merck, Nestle Health Science, Danone, Allergan, and Takeda, has received research grants for other investigator-driven studies/clinical trial funding from AbbVie, Janssen, Falk Pharma, Danone, and A2 Milk Company, and has received speaker's fees from Ferring, Takeda, AbbVie, Janssen, Fresenius Kabi, and Pfizer; Richard Gearry has served on the advisory boards of AbbVie, MSD, Janssen, and Baxter, has received research grants for other investigator-driven studies/clinical trial funding from AbbVie and Ferring, and has received speaker's fees from MSD, Ferring, Takeda, AbbVie, and Janssen; Alissa Walsh has served on the advisory boards of AbbVie, Ferring, Janssen, Takeda, and Hospira, and has received speaker's fees from Ferring, Takeda, AbbVie, Janssen, and Hospira; Susan Connor has served on the advisory boards of AbbVie, Janssen, Hospira, and Vifor, and has received speaker's fees from Ferring, AbbVie, Janssen, and Shire; Ian Lawrance has served on the advisory boards of AbbVie, MSD, Ferring, Janssen, Takeda, and Hospira, has received speaker's fees from Ferring, Takeda, AbbVie, Janssen, Hospira, and Shire; Jane Andrews has served on the advisory boards of AbbVie, Ferring, Janssen, Takeda, Hospira, Abbott, Shire, and Pfizer, and has received research grants for other investigator-driven studies/clinical trial funding from AbbVie, Janssen, Ferring, Abbott, Takeda, Shire, Hospira, and Pfizer; Signe Wildt has served on the advisory boards of MSD and Tillotts, and has received speaker’s fees from MSD and Takeda; Miles Sparrow has served on the advisory boards of Janssen, Takeda, and Hospira, and has received speaker’s fees from Ferring, Takeda, AbbVie, Janssen, Hospira, and Shire; Sally Bell has received consultation fees from AbbVie and Janssen, has received research grants for other investigator-driven studies/clinical trial funding from AbbVie, Janssen, and Shire, and has received speaker’s fees from AbbVie and Janssen; Mette Julsgaard has received speaker’s fees from MSD, Ferring, UCB, and Takeda; Christian Hvas has received speaker’s fees from MSD, Takeda, Tillotts, and AbbVie; Jens Kjeldsen has received speaker’s fees from MSD, Takeda, and Bristol-Myers Squibb; William Connell has received speaker’s fees from AbbVie and Janssen; and Steven Brown has received speaker’s fees from AbbVie and Janssen. The remaining authors disclose no conflicts.
Funding The intra-uterine ExposuRe to Anti-tnf-alpha therapy (ERA) study was supported by unrestricted grants from the Health Research Fund of the Central Denmark Region, Colitis-Crohn Denmark, the A.P. Moeller Foundation of the Advancement of Medical Science, the Department of Gastroenterology at Monash University, and Alfred Hospital (Melbourne, Victoria, Australia). The external funders had no involvement in any aspect of the study or writing of the report.
Author names in bold designate shared co-first authors.