PDF(Pubmed)
Abstract：
Treatment for pregnant women with psoriasis is limited by the lack of information typically related to clinical trials. While anti-tumor necrosis factor (TNF) drugs offer therapeutic benefits, their safety during pregnancy is a concern. Notably, certolizumab is comparatively safer than adalimumab, etanercept, infliximab, and golimumab according to the current recommendations. Thus, this study aimed to conduct a pharmacovigilance comparative analysis of maternal and neonatal outcomes associated with certolizumab versus other anti-TNF drugs by using data from EudraVigilance. A descriptive analysis was performed of Individual Case Safety Reports (ICSRs) associated with an anti-TNF drug and related to the pregnant patients with psoriasis from 2009 and 2023, focusing our analysis on the specific pregnancy outcomes and fetal/neonatal disorders. The most common pregnancy-related adverse event was spontaneous abortion, predominantly related to adalimumab and certolizumab. Certolizumab was also reported in cases of caesarean section, gestational diabetes, abortion, fetal death, fetal distress syndrome, pre-eclampsia, and premature separation of placenta. Generally, the findings from our study depicted a safety profile that overlapped for each anti-TNF drug, both in maternal/neonatal outcomes and other adverse events, suggesting no substantial differences between treatments. We advocate for further investigations before making concrete recommendations.
摘要：
对患有银屑病的孕妇的治疗由于缺乏通常与临床试验相关的信息而受到限制。虽然抗肿瘤坏死因子（TNF）药物提供治疗益处，他们在怀孕期间的安全是一个问题。值得注意的是,certolizumab比阿达木单抗更安全，依那西普,英夫利昔单抗,和戈利木单抗根据目前的建议。因此，本研究利用EudraVigilance的数据,对certolizumab与其他抗TNF药物相关的母婴结局进行药物警戒性比较分析.对2009年和2023年与抗TNF药物相关的个体病例安全性报告（ICSR）进行了描述性分析，重点分析了特定的妊娠结局和胎儿/新生儿疾病。最常见的妊娠相关不良事件是自然流产，主要与阿达木单抗和塞托珠单抗有关。Certolizumab在剖腹产病例中也有报道，妊娠期糖尿病,流产,胎儿死亡,胎儿窘迫综合征,先兆子痫,胎盘过早分离.一般来说,我们研究的结果描述了每种抗TNF药物重叠的安全性，在产妇/新生儿结局和其他不良事件中，表明治疗之间没有实质性差异。我们主张在提出具体建议之前进行进一步调查。
