Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review
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SYSTEMATIC REVIEW
Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review N. Ghalandari1,2,4 · R. J. E. M. Dolhain1,4 · J. M. W. Hazes1,2,4 · E. P. van Puijenbroek3 · M. Kapur5 · H. J. M. J. Crijns2
© The Author(s) 2020
Abstract Background Inflammatory autoimmune diseases are chronic diseases that often affect women of childbearing age. Therefore, detailed knowledge of the safety profile of medications used for management of inflammatory autoimmune diseases during pregnancy is important. However, in many cases the potential harmful effects of medications (especially biologics) during pregnancy (and lactation) on mother and child have not been fully identified. Objective Our aim was to update the data on the occurrence of miscarriages and (major) congenital malformations when using biologics during pregnancy based on newly published articles. Additionally, we selected several different secondary outcomes that may be of interest for clinicians, especially information on adverse events in the use of a specific biologic during pregnancy. Material and Methods A search was conducted from 1 January 2015 until 4 July 2019 in Embase.com, Medline Ovid, Web of Science, Cochrane CENTRAL, and Google Scholar with specific search terms for each database. Selection of publications was based on title/abstract and followed by full text (double blinded, two researchers). An overview was made based on outcomes of interest. References of the included publications were reviewed to include and minimize the missing publications. Results A total of 143 publications were included. The total number of cases ranged from nine for canakinumab to 4276 for infliximab. The rates of miscarriages and major congenital malformations did not show relevant differences from those rates in the general population. Conclusion Despite limitations to our study, no major safety issues were reported and no trend could be identified in the reported malformations.
Key Points
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40265-020-01376-y) contains supplementary material, which is available to authorized users. * N. Ghalandari [email protected] 1
Department of Rheumatology, Erasmus University Medical Center, Rotterdam, The Netherlands
2
Medicines Evaluation Board (MEB), Graadt van Roggenweg 500, 3531 AH Utrecht, The Netherlands
3
Netherlands Pharmacovigilance Centre Lareb, ‘s Hertogenbosch, The Netherlands
4
Academic Center of Inflammunity, Erasmus University Medical Center, Rotterdam, The Netherlands
5
Utrecht University of Medical Sciences, Utrecht, The Netherlands
The rates of miscarriages and major congenital malformations after exposure to biologics during pregnancy do not deviate from these rates in the general population. It is likely that use of adalimumab, certolizumab pegol, and etanercept is safe during pregnancy. Data on risks of using abatacept, anakinra, canakinumab, golimumab, rituximab, tocilizumab, ustekinumab, and vedol
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