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

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.

Estimating Risk of Multiple Sclerosis Disease Reactivation in Pregnancy and Postpartum: The VIPRiMS Score

“…The main strengths of this study are its population-based approach and the detailed characterization of the study cohort provided by the high-quality data from certified specialized MS centers. The characteristics of the study cohorts with respect to age at conception, disease duration, and disease activity are in line with other cohorts presented in the literature suggesting generalizability of our results ( 3 , 4 , 7 , 10 , 23 ). Another strength is the robust and standardized statistical approach to generation and validation of the risk score ( 16 , 19 , 20 ).…”

Monoclonal Antibodies in the Treatment of Relapsing Multiple Sclerosis: an Overview with Emphasis on Pregnancy, Vaccination, and Risk Management

“…The rate of birth defects and spontaneous abortions was found to be similar to that of the general population [ 48 ]. The same findings were obtained in a retrospective analysis from the Austrian MS Treatment Registry [ 49 ]. However, in one case series study, mild to moderate thrombocytopenia and anemia were detected in 10 of 13 newborns when natalizumab was prescribed in the third trimester of gestation [ 50 ].…”

Exposure to natalizumab throughout pregnancy: effectiveness and safety in an Italian cohort of women with multiple sclerosis

“…This study is the first multicentre retrospective study evaluating a large sample of pregnant women exposed to NTZ beyond the first trimester of pregnancy. This population has been poorly investigated by previous works,17 which have mainly reported data on women exposed to NTZ until conception8 18 or during the first trimester of pregnancy 14 19…”

“…Currently, the scientific debate is rather focused on how long NTZ should be maintained during pregnancy, considering potential safety issues for newborns. Several studies explored the effects of prolonging treatment after conception, but the validity of their results is limited by small sample sizes 12–14. In this study, we collected data from 29 Italian MS centres with the aim of assessing the effectiveness of NTZ continuation during pregnancy compared with its discontinuation before pregnancy and close to conception.…”