Outcomes following biosimilar TNF inhibitor use for inflammatory-mediated immune disorders in pregnancy

R Scott¹, H Parker², S Mccartney², P Harrow², D Williams^{1

3}, I Giles^{4

5}

Affiliations

¹ Department of Obstetrics, University College London Hospital NHS Foundation Trust, London, UK.
² Department of Gastroenterology, University College London Hospital NHS Foundation Trust, London, UK.
³ The Institute for Women's Health, University College London, London, UK.
⁴ Department for Rheumatology, University College London Hospital NHS Foundation Trust, London, UK.
⁵ Centre for Rheumatology, University College London, University College London Hospitals NHS Foundation Trust, London, UK.

PMID: 35845229
PMCID: PMC9277732
DOI: 10.1177/1753495X211028779

Outcomes following biosimilar TNF inhibitor use for inflammatory-mediated immune disorders in pregnancy

R Scott et al. Obstet Med. 2022 Jun.

. 2022 Jun;15(2):104-107.

doi: 10.1177/1753495X211028779. Epub 2021 Sep 2.

Authors

R Scott¹, H Parker², S Mccartney², P Harrow², D Williams^{1

3}, I Giles^{4

5}

Affiliations

¹ Department of Obstetrics, University College London Hospital NHS Foundation Trust, London, UK.
² Department of Gastroenterology, University College London Hospital NHS Foundation Trust, London, UK.
³ The Institute for Women's Health, University College London, London, UK.
⁴ Department for Rheumatology, University College London Hospital NHS Foundation Trust, London, UK.
⁵ Centre for Rheumatology, University College London, University College London Hospitals NHS Foundation Trust, London, UK.

PMID: 35845229
PMCID: PMC9277732
DOI: 10.1177/1753495X211028779

Abstract

Background: Biosimilar tumour necrosis factor inhibitors (TNFi) are increasingly used to treat inflammatory immune-mediated disorders as they cost less than the originator biologic drug. More women are therefore becoming pregnant on biosimilar TNFi. This is the first paper to explore the safety and efficacy of biosimilar therapies in pregnancy.

Methods: A retrospective review of clinical data reviewed pregnancy outcomes and inflammatory disease activity in 18 pregnancies where the mother was using a biosimilar TNFi at conception.

Results: Biosimilar therapy was not associated with congenital abnormalities, preterm birth or other adverse pregnancy outcomes. Stopping biosimilar TNFi in pregnancy was associated with childbirth at an earlier gestation, as well as a flare of inflammatory disease in pregnancy or post-partum.

Conclusions: Women and clinicians should feel confident in using biosimilar TNFi in early pregnancy, and continuing them through pregnancy to prevent flares in late pregnancy or the early post-partum.

Keywords: Biosimilar; gastroenterology; inflammatory; pregnancy; rheumatology.

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Conflict of interest statement

Declaration of conflicting interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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References

1. Isaacs JD, Cutolo M, Keystone EC, et al.. Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody. J Intern Med 2016; 279: 41–59. - PubMed
1. Bonovas S, Fiorino G, Allocca M, et al.. Biologic therapies and risk of infection and malignancy in patients with inflammatory bowel disease: a systematic review and network meta-analysis. Clin Gastroenterol Hepatol 2016; 14: 1385–1397.e10. - PubMed
1. Giles I, Yee CS, Gordon C. Stratifying management of rheumatic disease for pregnancy and breastfeeding. Nat Rev Rheumatol 2019; 15: 391–402. - PubMed
1. World Health Organization. Expert Committee on Biological Standardization. Geneva, 19 to 23 October 2009. Guidelines on evaluation of similar biotherapeutic products (SBPs), https://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPE... (2010, accessed 21 June 2021).
1. NHS England » What is a biosimilar medicine? https://www.england.nhs.uk/publication/what-is-a-biosimilar-medicine/ (accessed 21 June 2021).

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Outcomes following biosimilar TNF inhibitor use for inflammatory-mediated immune disorders in pregnancy

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Outcomes following biosimilar TNF inhibitor use for inflammatory-mediated immune disorders in pregnancy

Authors

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Conflict of interest statement

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