Kwak-Kim Joanne, Maier Curtis C, Villano Caren M, Bowman Christopher J, Brennan Frank R, Stanislaus Dinesh, Hillegas Aimee, Krayer John, Prell Rodney A, Papenfuss Tracey L, Cauvin Annick, Gamse Joshua, Dahlman Anna, Enright Brian, Leshin Lawrence, Rao Gautham K, Helms Whitney, Fuller Claudette L, Yang Xiuhua, Chen Connie, Mitchell-Ryan Shermaine
Chicago Medical School, Rosalind Franklin University of Medicine and Science, Reproductive Medicine and Immunology, Obstetrics and Gynecology, Clinical Sciences Department, Vernon Hills, IL, USA.
GSK, Nonclinical Safety, Collegeville, PA, USA.
J Reprod Immunol. 2025 Jun;169:104453. doi: 10.1016/j.jri.2025.104453. Epub 2025 Feb 16.
There have been remarkable advancements in understanding the complex and dynamic immune biological processes engaged during all stages of pregnancy. Exquisite control of immune processes is critical to successful outcome in all stages of pregnancy from ovulation to birth. There are many immunomodulatory therapeutics that may offer beneficial treatment options for a variety of diseases (e.g., inflammation/autoimmunity, cancer) to patients that are or desire to become pregnant. It is important to understand the potential for these immunomodulatory therapeutics to alter the critical immune processes in pregnancy to inform clinical risk relative to successful pregnancy. The Health and Environmental Sciences Institute-Developmental and Reproductive Toxicology/Immuno-safety Technical Committee (HESI DART/ITC) conducted a survey on approaches to assess adverse pregnancy outcomes with immunomodulators. HESI DART/ITC also organized a workshop for an extended discussion on immune mechanisms during pregnancy, the adequacy of current tools/methodologies to identify concerns for potential pregnancy hazards from immunomodulatory therapies, ways to identify and address scientific gaps, and global regulatory considerations across various immunomodulatory modalities and indications. In this manuscript we summarize learnings from these efforts to characterize risk within this patient population, promote more informed treatment decisions, and enable safer pharmacological interventions during pregnancy.
在理解孕期各个阶段所涉及的复杂且动态的免疫生物学过程方面已经取得了显著进展。免疫过程的精确调控对于从排卵到分娩的孕期各个阶段的成功结局至关重要。有许多免疫调节疗法可能为患有或希望怀孕的患者提供针对多种疾病（例如炎症/自身免疫性疾病、癌症）的有益治疗选择。了解这些免疫调节疗法改变孕期关键免疫过程的可能性，对于告知与成功妊娠相关的临床风险很重要。健康与环境科学研究所发育与生殖毒理学/免疫安全技术委员会（HESI DART/ITC）针对评估免疫调节剂对不良妊娠结局的方法进行了一项调查。HESI DART/ITC还组织了一次研讨会，以深入讨论孕期的免疫机制、当前工具/方法对于识别免疫调节疗法潜在妊娠危害问题的充分性、识别和解决科学差距的方法以及各种免疫调节方式和适应症的全球监管考量。在本手稿中，我们总结了这些努力的成果，以描述该患者群体的风险特征，促进更明智的治疗决策，并在孕期实现更安全的药物干预。
