怀孕期间暴露于戈利穆马布:来自公司全球安全数据库的结果
Marijo Otero-Lobato1, Adesoji Adeyemo2, Michelle Higley3
1Janssen Biologics BV, Medical Affairs, Leiden, The Netherlands.
关于在怀孕期间使用戈利穆马布 (GLM) 的有限数据显示,结果与一般人口的比例一致. 这项研究分析了暴露于GLM的怀孕,发现主要先天性异常率与背景水平相比较.
科学领域:
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
- 生殖医学 生殖医学
背景情况:
- 关于在怀孕期间使用golimumab (GLM) 的数据很少.
- 了解使用GLM的女性的怀孕结果对于明智的临床决策至关重要.
研究的目的:
- 为了评估怀孕期间接受GLM治疗的妇女的怀孕结果.
- 从全球安全数据库中总结有关GLM暴露妊娠的累积数据.
主要方法:
- 医学确认的孕妇在怀孕期间或怀孕前暴露于GLM的情况进行了审查.
- 分析了前性报告病例中的怀孕结果和先天性异常.
- 数据从公司的全球安全数据库 (GSD) 收集,截至2022年5月31日.
主要成果:
- 确定了261个前性报告的暴露于GLM的怀孕.
- 活产发生在82.0%的病例中;自发流产发生在11.9%的病例中.
- 报告了7种先天性异常 (2.7%),其中5种 (2.3%的活产) 被归类为重大,与背景率一致.
结论:
- 在GLM暴露后的怀孕结果似乎与一般人口的发育率一致.
- 在暴露于GLM的怀孕中,主要先天性异常的发病率与背景发病率相比较.
- 这些发现有助于在怀孕期间使用GLM的有限但越来越多的证据.
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