Pregnancy Outcomes in Patients With Multiple Sclerosis Exposed to Natalizumab-A Retrospective Analysis From the Austrian Multiple Sclerosis Treatment Registry.

Michael Guger,Gerhard Ransmayr,Fritz Leutmezer,Dierk Oel,Christian Enzinger,Thomas Berger,Martina Drabauer,Gerhard Traxler,Franziska Di Pauli,Doris Leitner-Pohn

doi:10.3389/fneur.2020.00676

Abstract

Objectives: To analyze safety and impact of natalizumab (NTZ) exposure on the disease course, pregnancy, and newborn outcomes of relapsing-remitting multiple sclerosis (RRMS) patients from the Austrian Multiple Sclerosis Treatment Registry (AMSTR).Materials and Methods: Twelve pregnancies of 11 women with RRMS exposed to treatment with NTZ were identified from the AMSTR. Exposure to NTZ was defined as treatment with NTZ from 8 weeks prior to the start of the last menstrual period and onward. All patients completed a standardized questionnaire regarding pregnancy and newborn outcomes until the postpartum period for up to 12 months.Results: NTZ was stopped on average 46 days after the last menstrual period. There were 11 live births and one elective termination due to ectopic pregnancy. Mean gestational age of live born individuals was 39.0 weeks [standard deviation (SD) ± 1.1]. Mean birth weight and length were 3,426 g (SD ± 348) and 51.9 cm (SD ± 1.9), respectively. Apgar scores 1 min after birth were normal, with 9.2 points on average. One child displayed hip dysplasia as the only congenital malformation documented in this cohort. Three patients experienced relapses during pregnancy and three patients in the postpartum period, resulting in confirmed Expanded Disability Status Scale (EDSS) progression in four of them.Conclusion: In this cohort, there was no increased risk concerning pregnancy and newborn outcomes due to NTZ exposure. However, relapses occurring during pregnancy and postpartum period resulted in confirmed disability.

Highlights

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system diagnosed predominantly in females mostly during the reproductive age [1]
The Austrian Multiple Sclerosis Treatment Registry (AMSTR) is compliant with Austrian laws on bioethics, and it was approved by the ethical committee of the Medical University of Vienna (EC number 2096/2013)
One patient became pregnant twice, and both pregnancies were included in this analysis

Summary

Introduction

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system diagnosed predominantly in females mostly during the reproductive age [1]. Female patients need to be counseled to balance the potential benefits and risks of drug exposure when considering treatment options before or during pregnancy [2]. There is a high degree of variability in the course of disease and its response to treatment. Limited data are available on the outcome of exposure to NTZ during pregnancy [3,4,5,6,7,8,9]. There is limited information concerning the course of MS during pregnancy after NTZ cessation [6, 9, 10], which, would be needed for optimizing patient management in this particular scenario

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