{"id":49,"title":"Monoclonal Antibody Dispensing Around Pregnancy: A Descriptive Analysis Using Electronic Health Records in Italy","title_zh":"妊娠前后单克隆抗体配药趋势：基于意大利伦巴第电子健康档案的人群描述性分析","url":"https://pubmed.ncbi.nlm.nih.gov/42989522","doi":"10.1002/pds.70518","pmid":"42989522","journal":"Pharmacoepidemiol Drug Saf","kind":"paper","lang":"en","published_at":"2026-11-01T00:00:00+00:00","fetched_at":"2026-11-08T03:43:52+00:00","authors":["Aiton E","Nazzari V","Cornish R","Faber BG","Burden C","Birchenall K","Borges MC","Lawlor DA","Zuccolo L"],"primary_topic":"repro-immunology","topics":[{"slug":"art-clinical","score":1.0,"hits":["assisted reproductive"]},{"slug":"repro-immunology","score":1.0,"hits":["autoimmune"]},{"slug":"ethics-policy","score":1.0,"hits":["guidelines"]}],"topic_score":1.0,"preference_score":10.0,"preference_labels":["卵母细胞-胚胎转换 / 母源-合子转换"],"llm_score":63.0,"final_score":73.0,"score_dims":{"novelty":62,"rigor":82,"impact":52,"relevance":48,"translation":58},"recommend_reason":"大样本人群登记数据清晰刻画了孕期单抗用药的真实世界趋势与停药行为，对合并自身免疫病的备孕/ART患者用药咨询有参考价值；但主题属药物流行病学与妊娠期用药安全，与胚胎/ART实验室核心问题距离较远，且ART仅作为次要关联因素出现。","keywords":["单克隆抗体","妊娠期用药","停药模式","药物流行病学","自身免疫病","辅助生殖技术"],"selected":1,"story_id":243,"llm_provider":"deepseek","llm_model":"deepseek-flash","llm_effort":"low","source_key":"pubmed-art","source_name":"PubMed · 辅助生殖临床","source_tier":1,"mention_count":1,"has_interpretation":false,"journal_key":null,"journal_tier":"unknown","journal_if":null,"is_mock":false,"summary_zh":"该研究利用意大利伦巴第2012—2024年电子健康档案，纳入1 871 929名14—49岁育龄女性及855 865次妊娠，描述自身免疫病用单克隆抗体生物制剂在妊娠前后的配药趋势。结果显示，妊娠期单抗配药率由2012年的0.0041%升至2024年的0.27%（增长逾60倍）；妊娠期配药比例从孕前0.081%降至孕晚期0.051%；既往用药者中53.3%（385/722）在孕前或孕期停药，孕期换药罕见（3.3%），停药比例随时间下降且因药物而异。社会人口学因素与停药关联有限，辅助生殖技术使用呈提示性关联（OR=1.92，95%CI 0.98–3.77）。结论认为配药增加与停药减少可能反映药物可及性提升、安全性证据累积及指南更新。","summary":"PURPOSE: To describe trends in dispensing of monoclonal antibody biologics (mAbs) for autoimmune conditions during and around pregnancy. METHODS: We conducted a population-wide study of women of reproductive age (14-49 years) resident in Lombardy, Italy, between 2012 and 2024. We described trends over time in the prevalence of mAb dispensations among women of reproductive age, and during pregnancy. For each pregnancy, we assessed the prevalence of mAb dispensations before, during, and after pregnancy in trimesters. We described dispensing patterns and explored maternal factors associated with discontinuation. RESULTS: We included 1 871 929 women of reproductive age and 855 865 pregnancies. Prevalence of mAb dispensing during pregnancy increased over 60-fold over the study period, from 0.0041% in 2012 to 0.27% in 2024. Pregnancy affected mAb dispensing, with prevalence decreasing from 0.081% before pregnancy to 0.051% by the third trimester. Over half (n = 385/722, 53.3%) of pre-existing mAb users discontinued before or during pregnancy, while switching between mAbs during pregnancy was rare (n = 24/722, 3.3%). Discontinuation decreased over time, and varied substantially between mAbs. We found limited evidence that sociodemographic factors were associated with discontinuation, but that some health factors may be, such as use of assisted reproductive technology (OR = 1.92, 95% CI: 0.98-3.77). CONCLUSIONS: Italian population-wide data from 2012 to 2024 show an increase in mAbs dispensed during pregnancy, and fewer instances of discontinuing these drugs over time. These trends may reflect increasing drug availability, accumulating safety evidence, and recent changes in guidelines for mAb use in pregnancy.","interpretation_basis":null,"fulltext_status":null,"interpretation":null,"fulltext":{"available":false,"status":null,"reason":"尚未抓取全文（未入选、分数未达阈值，或还没跑 fulltext 步骤）","pmcid":null,"license":null,"chars":0,"source":null,"fetched_at":null}}