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Published in: Clinical Pharmacokinetics 5/2024

Open Access 07-04-2024 | Infliximab | Systematic Review

Pharmacokinetics of Monoclonal Antibodies Throughout Pregnancy: A Systematic Literature Review

Authors: J. van Gendt, R. Emaus, M. C. Visschedijk, D. J. Touw, D. G. Bouwknegt, K. de Leeuw, J. R. Prins, P. Malik, Paola Mian

Published in: Clinical Pharmacokinetics | Issue 5/2024

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Abstract

Background and Objective

Although little information is available on the pharmacokinetics (PK) of monoclonal antibodies (mAbs) during pregnancy, multiple mAbs are being used during pregnancy for various indications. The aim of this systematic literature review was to characterize the PK of mAbs throughout pregnancy.

Methods

A systematic literature search was carried out in PubMed and Embase on 21 April 2023. Articles were included when information on PK or exposure parameters of mAbs in pregnant women was available.

Results

A total of 42 relevant articles were included, of which eight discussed adalimumab, three certolizumab pegol, five eculizumab, one golimumab, 12 infliximab (IFX), two natalizumab, one canakinumab, one omalizumab, five tocilizumab, eight ustekinumab, and five vedolizumab. One of the 42 studies reported information on clearance (CL) and volume of distribution (VD) of IFX; all other studies only reported on serum concentrations in the pre-pregnancy state, different trimesters, and the postpartum period. For all of the assessed mAbs except IFX, serum concentrations were similar to concentrations in the pre-pregnancy state or modestly decreased. In contrast, IFX trough concentrations generally increased in the second and third trimesters in comparison to the non-pregnant state.

Conclusion

Available information suggests that the anatomical and physiological changes throughout pregnancy may have meaningful effects on the PK of mAbs. For most mAbs (not IFX), modestly higher dosing (per mg) maybe needed during pregnancy to sustain a similar serum exposure compared to pre-pregnancy.
Appendix
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Metadata
Title
Pharmacokinetics of Monoclonal Antibodies Throughout Pregnancy: A Systematic Literature Review
Authors
J. van Gendt
R. Emaus
M. C. Visschedijk
D. J. Touw
D. G. Bouwknegt
K. de Leeuw
J. R. Prins
P. Malik
Paola Mian
Publication date
07-04-2024
Publisher
Springer International Publishing
Published in
Clinical Pharmacokinetics / Issue 5/2024
Print ISSN: 0312-5963
Electronic ISSN: 1179-1926
DOI
https://doi.org/10.1007/s40262-024-01370-7

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