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Effect of Anti-TNF Biologic Exposure During Pregnancy on Villitis of Unknown Etiology Diagnoses in Patients with Autoimmune Disease

  • Maternal Fetal Medicine/Biology: Original Article
  • Published:
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Abstract

Tumor necrosis factor-α (TNF-α) antagonists are highly effective in controlling autoimmune diseases. This has led to speculation that they might also be useful in treating inflammatory placental conditions, such as chronic villitis of unknown etiology (VUE). VUE affects 10–15% of term placentas and is associated with recurrent fetal growth restriction (FGR) and pregnancy loss. We aimed to evaluate outcomes in patients with autoimmune diseases with and without anti-TNF-α biologic exposure during gestation. This retrospective cohort study compared pregnant women with autoimmune disease taking anti-TNF-α biologics (n = 89) to pregnant women with autoimmune disease but not taking a biologic (n = 53). We extracted data on all patients meeting our inclusion criteria over a 20-year period. Our primary outcome was the diagnosis of VUE by histology. Our secondary outcomes were maternal and neonatal complications such as preeclampsia, FGR, and neonatal intensive care admission. Kruskal–Wallis and chi-squared tests were performed as appropriate for statistical analysis. Maternal characteristics were comparable between groups, and there was no increase in adverse pregnancy outcomes based on anti-TNF-α treatment. Exposure to anti-TNF-α therapy had no significant effect on the incidence of VUE or other obstetric complications. Within the cohort exposed to anti-TNF-α biologics during pregnancy, the rate of VUE was 9.3%, which is comparable to the reported general population risk. Our data support the safety profile of biologic use in pregnancy.

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Data Availability

De-identified data will be provided by the corresponding author upon reasonable request.

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Funding

Funding support for this project was provided by the NIH HD065987 (EALE) and a Mayo Clinic Career Development Award (EALE).

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Mayo Clinic, 200 First Ave. SW, Rochester, MN, 55905, USA

    Hannah M. Scott, Sylvie Girard, Regan N. Theiler & Elizabeth Ann L. Enninga

  2. Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA

    Ramila Mehta & Megan E. Branda

  3. ICON PLC, Nashville, TN, USA

    Jennifer Hughes

  4. Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA

    Sunanda V. Kane

  5. Department of Immunology, Mayo Clinic, Rochester, MN, USA

    Sylvie Girard & Elizabeth Ann L. Enninga

  6. Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA

    Andrew P. Norgan

Authors
  1. Hannah M. Scott
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  9. Elizabeth Ann L. Enninga
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Corresponding author

Correspondence to Elizabeth Ann L. Enninga.

Ethics declarations

Ethics Approval

This study was approved by the Mayo Clinic Institutional Review Board, application #22–0016101, on June 16, 2022.

Consent to Participate

Only data from patients who provided Minnesota Research Authorization was gathered for this analysis.

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All authors have read, reviewed, and approved the work submitted in this manuscript.

Conflict of Interest

SVK is a consultant for Fresenius Kabi and Janssen, which both produce anti-TNF molecules. RNT is an advisor to Delfina and has a know-how agreement with HeraMed. The remaining authors report no conflict of interest.

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Scott, H.M., Mehta, R., Branda, M.E. et al. Effect of Anti-TNF Biologic Exposure During Pregnancy on Villitis of Unknown Etiology Diagnoses in Patients with Autoimmune Disease. Reprod. Sci. 31, 997–1005 (2024). https://doi.org/10.1007/s43032-023-01402-w

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  • DOI: https://doi.org/10.1007/s43032-023-01402-w

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