Friend Susan, Richman Sandra, Bloomgren Gary, Cristiano Lynda M, Wenten Madé
Biogen, Innovation House, 70 Norden Road, Maidenhead, Berkshire, SL6 4AY, UK.
Biogen, Cambridge, MA, USA.
BMC Neurol. 2016 Aug 24;16(1):150. doi: 10.1186/s12883-016-0674-4.
Patients with multiple sclerosis (MS) or Crohn's disease (CD) being treated with natalizumab (Tysabri®, Biogen) who are planning to become pregnant or discover they are pregnant after exposure to natalizumab are currently advised to balance the potential benefits and potential risks of exposure when considering treatment options. This study was undertaken to evaluate pregnancy outcomes of women with MS or CD who were exposed to natalizumab at any time within 3 months prior to conception or during pregnancy. A pregnancy registry was created to better understand the effect of natalizumab exposure on pregnancy outcomes.
The Tysabri Pregnancy Exposure Registry was a global, observational exposure registration and follow-up study. Evaluations included spontaneous abortions (<22 weeks gestational age), fetal losses (≥22 weeks gestational age), ectopic pregnancies, elective or therapeutic terminations, stillbirths, birth defects, and live births. Birth defects were reviewed and coded in accordance with the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of birth defects.
A total of 369 patients with MS and 7 patients with CD were enrolled prospectively, of whom 355 patients (99.4 %; 349 MS and 6 CD) had known pregnancy outcomes (including 8 twin sets). The spontaneous abortion rate was 9.0 % (n = 32; 95 % confidence interval [C. I.], 6.3-12.5 %). An independent advisory committee review determined the major birth defect rate to be 5.05 % (16 of 316 live births + 1 elective abortion; 95 % C. I., 2.9-8.1 %). The mean gestational age of the live-born infants was 38.3 weeks, and the mean birth weight was 3158.3 g.
Although the overall rate of birth defects was higher than that observed by the MACDP, these registry outcomes showed no specific pattern of malformations that would suggest a drug effect, and the spontaneous abortion rate was consistent with that of the general population.
ClinicalTrials.gov NCT00472992 (11 May 2007).
正在接受那他珠单抗（泰萨比®，百健公司）治疗的多发性硬化症（MS）或克罗恩病（CD）患者，若计划怀孕或在接触那他珠单抗后发现自己怀孕，目前建议在考虑治疗方案时权衡接触药物的潜在益处和潜在风险。本研究旨在评估在受孕前3个月内或孕期任何时间接触过那他珠单抗的MS或CD女性的妊娠结局。创建了一个妊娠登记处，以更好地了解那他珠单抗接触对妊娠结局的影响。
泰萨比妊娠暴露登记处是一项全球性的观察性暴露登记和随访研究。评估内容包括自然流产（妊娠龄<22周）、胎儿丢失（妊娠龄≥22周）、异位妊娠、选择性或治疗性终止妊娠、死产、出生缺陷和活产。出生缺陷根据亚特兰大大都会先天性缺陷项目（MACDP）的出生缺陷分类进行审查和编码。
共前瞻性纳入369例MS患者和7例CD患者，其中355例患者（99.4%；349例MS患者和6例CD患者）有已知的妊娠结局（包括8对双胞胎）。自然流产率为9.0%（n = 32；95%置信区间[C.I.]，6.3 - 12.5%）。一个独立咨询委员会审查确定主要出生缺陷率为5.05%（316例活产 + 1例选择性流产中的16例；95% C.I.，2.9 - 8.1%）。活产婴儿的平均妊娠龄为38.3周，平均出生体重为3158.3克。
尽管出生缺陷的总体发生率高于MACDP观察到的发生率，但这些登记处的结果未显示出表明药物影响的特定畸形模式，且自然流产率与一般人群一致。
ClinicalTrials.gov NCT00472992（2007年5月11日）。
