Pharmacovigilance Pregnancy Data in a Population of Japanese Patients With Chronic Inflammatory Disease Exposed to Certolizumab Pegol

IF 2.4 4区医学 Q2 RHEUMATOLOGY

International Journal of Rheumatic Diseases Pub Date : 2025-01-15 DOI:10.1111/1756-185X.70048

Mikako Goto, Shigeru Saito, Angela E. Scheuerle, Shinya Yasuda, Niamh Houston, Thomas Kumke, Bernard Lauwerys, Atsuko Murashima

{"title":"Pharmacovigilance Pregnancy Data in a Population of Japanese Patients With Chronic Inflammatory Disease Exposed to Certolizumab Pegol","authors":"Mikako Goto, Shigeru Saito, Angela E. Scheuerle, Shinya Yasuda, Niamh Houston, Thomas Kumke, Bernard Lauwerys, Atsuko Murashima","doi":"10.1111/1756-185X.70048","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Aim</h3>\n \n <p>Uncontrolled chronic inflammatory diseases (CIDs) before, during, and after pregnancy, as well as some CID medications, can increase the risk of impaired fertility in addition to adverse maternal/pregnancy outcomes in women of childbearing age. We report pregnancy outcomes from prospectively reported pregnancies in Japanese women treated with certolizumab pegol (CZP).</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Data from July 2001 to November 2020 on CZP-exposed pregnancies from the CZP Pharmacovigilance safety database were reviewed. Pregnancy outcomes analyzed included live birth, ectopic pregnancy, abortion (miscarriage or medically indicated/elective), and stillbirth. Congenital anomalies (major and minor), preterm delivery, and low birth weight were also examined.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Among 149 prospective pregnancies with maternal CZP exposure and known outcomes identified in Japanese women, 111/149 (74.5%) involved at least first-trimester exposure and 53/149 (35.6%) were exposed in all trimesters; 135/149 (90.6%) live births, 12/149 (8.1%) abortions (11 miscarriages, one elective termination), 2/149 (1.3%) stillbirths, no ectopic pregnancies reported. One (0.7%) infant, whose mother had first-trimester exposure, manifested a minor congenital anomaly (accessory auricle). There were no major congenital anomalies. Among live births, 3/135 (2.2%) were preterm and 10/135 (7.4%) had low birth weight.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>The safety profile of CZP in pregnant Japanese women was consistent with published global data.</p>\n </section>\n </div>","PeriodicalId":14330,"journal":{"name":"International Journal of Rheumatic Diseases","volume":"28 1","pages":""},"PeriodicalIF":2.4000,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11733829/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Rheumatic Diseases","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/1756-185X.70048","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Aim

Uncontrolled chronic inflammatory diseases (CIDs) before, during, and after pregnancy, as well as some CID medications, can increase the risk of impaired fertility in addition to adverse maternal/pregnancy outcomes in women of childbearing age. We report pregnancy outcomes from prospectively reported pregnancies in Japanese women treated with certolizumab pegol (CZP).

Methods

Data from July 2001 to November 2020 on CZP-exposed pregnancies from the CZP Pharmacovigilance safety database were reviewed. Pregnancy outcomes analyzed included live birth, ectopic pregnancy, abortion (miscarriage or medically indicated/elective), and stillbirth. Congenital anomalies (major and minor), preterm delivery, and low birth weight were also examined.

Results

Among 149 prospective pregnancies with maternal CZP exposure and known outcomes identified in Japanese women, 111/149 (74.5%) involved at least first-trimester exposure and 53/149 (35.6%) were exposed in all trimesters; 135/149 (90.6%) live births, 12/149 (8.1%) abortions (11 miscarriages, one elective termination), 2/149 (1.3%) stillbirths, no ectopic pregnancies reported. One (0.7%) infant, whose mother had first-trimester exposure, manifested a minor congenital anomaly (accessory auricle). There were no major congenital anomalies. Among live births, 3/135 (2.2%) were preterm and 10/135 (7.4%) had low birth weight.

Conclusion

The safety profile of CZP in pregnant Japanese women was consistent with published global data.

Abstract Image

查看原文本刊更多论文

暴露于Certolizumab Pegol的日本慢性炎症性疾病患者群体的药物警戒妊娠数据

目的：在怀孕前、怀孕期间和怀孕后不受控制的慢性炎症性疾病（CID），以及一些CID药物，可增加育龄妇女生育能力受损的风险，以及不良的孕产妇/妊娠结局。我们报告了接受certolizumab pegol （CZP）治疗的日本女性的妊娠结局。方法：回顾2001年7月至2020年11月CZP药物警戒安全数据库中暴露于CZP的妊娠数据。妊娠结局分析包括活产、异位妊娠、流产（流产或医学指征/选择性流产）和死产。先天性异常（主要和次要），早产和低出生体重也进行了检查。结果：在149名日本孕妇中，111/149（74.5%）至少在妊娠早期暴露于CZP， 53/149（35.6%）在妊娠全部暴露于CZP；135/149（90.6%）活产，12/149（8.1%）流产（11例流产，1例选择性终止妊娠），2/149（1.3%）死产，无异位妊娠报告。1例（0.7%）婴儿，其母亲在妊娠早期暴露，表现出轻微的先天性异常（副耳廓）。没有重大的先天性异常。在活产婴儿中，3/135（2.2%）为早产，10/135（7.4%）为低出生体重。结论：CZP在日本孕妇中的安全性与全球公布的数据一致。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

International Journal of Rheumatic Diseases RHEUMATOLOGY-

CiteScore

3.70

自引率

4.00%

发文量

362

审稿时长

1 months

期刊介绍： The International Journal of Rheumatic Diseases (formerly APLAR Journal of Rheumatology) is the official journal of the Asia Pacific League of Associations for Rheumatology. The Journal accepts original articles on clinical or experimental research pertinent to the rheumatic diseases, work on connective tissue diseases and other immune and allergic disorders. The acceptance criteria for all papers are the quality and originality of the research and its significance to our readership. Except where otherwise stated, manuscripts are peer reviewed by two anonymous reviewers and the Editor.