Safety of biologics in patients with autoimmune rheumatic diseases during pregnancy: Systematic review and meta-analysis

Shiran Li; Hongxi Liu; Siyu Zeng; Jingxian Xie; Zhimin Li; Yong Yang; Junlan Chuan

doi:10.1016/j.autrev.2025.103827

Safety of biologics in patients with autoimmune rheumatic diseases during pregnancy: Systematic review and meta-analysis

Autoimmun Rev. 2025 May 13;24(8):103827. doi: 10.1016/j.autrev.2025.103827. Online ahead of print.

Authors

Shiran Li¹, Hongxi Liu¹, Siyu Zeng¹, Jingxian Xie², Zhimin Li¹, Yong Yang³, Junlan Chuan⁴

Affiliations

¹ Department of Pharmacy, Personalized Drug Therapy Key Laboratory of Sichuan Province, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu 610072, China.
² Department of Pharmacy, Personalized Drug Therapy Key Laboratory of Sichuan Province, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu 610072, China; College of Pharmacy, Southwest Medical University, Luzhou, China.
³ Department of Pharmacy, Personalized Drug Therapy Key Laboratory of Sichuan Province, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu 610072, China. Electronic address: yyxpower@126.com.
⁴ Department of Pharmacy, Personalized Drug Therapy Key Laboratory of Sichuan Province, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu 610072, China. Electronic address: chuanjunlan@foxmail.com.

PMID: 40339681
DOI: 10.1016/j.autrev.2025.103827

Abstract

Background: Patients with autoimmune rheumatic diseases (ARDs) face the dual challenge of controlling disease activity while ensuring fetal safety during pregnancy. Biologics are increasingly used to treat ARDs, but evidence regarding their safety during pregnancy remains uncertain. This study aims to systematically evaluate the safety of biologics during pregnancy by performing a systematic review and meta-analysis.

Methods: A comprehensive search was conducted in major databases to identify studies involving pregnant ARDs patients treated with biologics from inception to 30th September 2024. The outcomes assessed included small for gestational age (SGA), cesarean section, preterm birth (PTB), low birth weight (LBW), gestational diabetes mellitus (GDM), pre-eclampsia, gestational hypertension, severe maternal infection, birth defects (BD), and a composite outcome of fetal miscarriage or death.

Results: A total of 40 studies involving 11,712 patients were included. The pooled prevalence of adverse pregnancy outcomes (APOs) in patients exposed to biologics was comparable to those observed in the general ARDs population. Compared to other biologics, tumor necrosis factor inhibitors (TNFis) was associated with a significantly lower prevalence of cesarean section (26.93 % vs. 63.64 %, p = 0.01), early pregnancy loss (10.44 % vs. 18.77 %, p = 0.03), and termination of pregnancy (8.59 % vs. 16.11 %, p < 0.01). Compared to csDMARDs, biologic use during pregnancy did not significantly increase the risk of APOs.

Conclusion: Exposure to biologics during pregnancy in ARDs patients does not significantly increase the risk of APOs, with TNFis showing a well-supported safety profile, while non-TNFi biologics may carry higher risks, requiring cautious evaluation.

Keywords: Autoimmune rheumatic disease; Biologics; Pregnancy outcome.

Publication types

Review