Hoffmann-La Roche Limited, Mississauga, Ontario, Canada.
Hoffmann-La Roche Limited, Mississauga, Ontario, Canada.
Mult Scler Relat Disord. 2022 Jun;62:103792. doi: 10.1016/j.msard.2022.103792. Epub 2022 Apr 6.
To report and describe the real-world use of ocrelizumab in women with multiple sclerosis (MS) in Canada before and/or during pregnancy as well as their fetal outcomes.
We identified retrospective and prospective Canadian pregnancy exposure cases from the Roche Global Safety Database from November 5, 2008 until March 31, 2021, and linked these cases to information within the Canadian Roche Patient Support Program (COMPASS). The analysis only included spontaneous reports or those from a non-interventional program. Details of the pregnancy exposures, fetal outcomes, as well as relevant patient characteristics, were collected.
A total of 107 cases of maternal exposures were retrieved, with 104 (97.2%) being prescribed ocrelizumab for relapsing-remitting MS (RRMS) and 105 (98.1%) being reported from the COMPASS program. Of these cases, 85 (79.4%) were prospective and 22 (20.6%) retrospective. Cases were pooled (n = 65), and unknown/lost to follow-up outcomes and ongoing pregnancies were excluded. All cases reporting an outcome were analyzed, including 47 (72.3%) live births (44.7% full term, 8.5% preterm, 46.8% unknown gestational age), 13 (20.0%) spontaneous abortions, 2 (3.1%) therapeutic abortions/elective terminations, and 3 (4.6%) ectopic pregnancies. One major congenital anomaly of the limb (polydactyly) was reported; however, multiple confounders were likely contributors. Of the total maternal exposures (n = 107), 50 cases (46.6%) were not exposed to ocrelizumab in utero, with 32 of these (64.0%) receiving their last ocrelizumab infusion >3 but ≤6 months prior to conception, 17 (34.0%) receiving it >6 months prior to conception and 1 case receiving it at an unknown time point not in utero. Among the 37 (34.6%) maternal exposure cases exposed in utero, 22 (59.5%) received their last ocrelizumab infusion ≤3 months prior to conception.
The data presented, although not without limitations, continues to suggest no increased risk of congenital anomalies and are consistent with ocrelizumab global pregnancy safety data and epidemiological rates.
报告并描述在加拿大，奥瑞珠单抗在女性多发性硬化症（MS）患者中的真实世界使用情况，包括其在妊娠前和/或妊娠期间的使用情况，以及她们的胎儿结局。
我们从罗氏全球安全数据库中检索了 2008 年 11 月 5 日至 2021 年 3 月 31 日期间的回顾性和前瞻性加拿大妊娠暴露病例，并将这些病例与加拿大罗氏患者支持计划（COMPASS）中的信息进行了关联。该分析仅包括自发报告或非干预性研究报告。收集了妊娠暴露、胎儿结局以及相关患者特征的详细信息。
共检索到 107 例母体暴露病例，其中 104 例（97.2%）为奥瑞珠单抗治疗复发缓解型多发性硬化症（RRMS），105 例（98.1%）来自 COMPASS 计划。这些病例中，85 例（79.4%）为前瞻性病例，22 例（20.6%）为回顾性病例。对所有病例进行了汇总（n=65），并排除了未知/失访结局和持续妊娠的病例。对所有报告结局的病例进行了分析，包括 47 例（72.3%）活产（44.7%足月，8.5%早产，46.8%未知胎龄）、13 例（20.0%）自然流产、2 例（3.1%）治疗性流产/选择性终止妊娠和 3 例（4.6%）异位妊娠。报告了 1 例肢体主要先天畸形（多指）；然而，可能存在多种混杂因素。在 107 例母体暴露病例中，50 例（46.6%）在妊娠期间未暴露于奥瑞珠单抗，其中 32 例（64.0%）在受孕前最后一次接受奥瑞珠单抗输注≥3 但≤6 个月，17 例（34.0%）在受孕前≥6 个月接受奥瑞珠单抗输注，1 例在妊娠期间未接受奥瑞珠单抗输注。在 37 例（34.6%）妊娠期间暴露的母体暴露病例中，22 例（59.5%）在受孕前最后一次接受奥瑞珠单抗输注≤3 个月。
尽管这些数据存在一定局限性，但仍提示奥瑞珠单抗不会增加先天畸形的风险，与奥瑞珠单抗全球妊娠安全性数据和流行病学数据一致。
