Cladribine and Pregnancy in Women with Multiple Sclerosis– A Cohort Study
Karen Dost-Kovalsky1, Nadine Bast1, Sabrina Haben1, Natalia Friedmann1, Theresa Oganowski1, Ralf Gold1, Sandra Thiel1, Kerstin Hellwig1
1Neurology, St Josef Hospital
Objective:

To assess pregnancy outcomes and disease activity after cladribine(CLAD) treatment in women with multiple sclerosis (MS)

Background:

Information on pregnancy outcomes after CLAD exposure in women with MS is scarce, data to disease activity during pregnancy and postpartum is lacking

Design/Methods:

Pregnancies after CLAD treatment, documented in the German Multiple Sclerosis and Pregnancy Registry are presented.The cohort was stratified to last CLAD intake i) after last menstrual period (LMP), ii) between LMP and 6-months before LMP and iii) > 6-months before LMP. Relapse data, including EDSS-values were verified by neurologists and negative pregnancy outcomes by treating physicians

Results:

112 pregnancies in women with MS occurred after CLAD treatment, three with pregnancy exposure after LMP (median exposure duration 29 days; range 23 – 39), 24 with pregnancy exposure during the last 6-months before LMP (median days between CLAD cessation and LMP 130 days; range 2 – 180) and 84 unexposed (median days between CLAD cessation and LMP 372.5 days; range 185 – 1901). So far, three (3.4%) spontaneous abortions and two elective abortions (2.3%) occured. 21 pregnancies are ongoing, five women are lost to follow-up. Among 81 live-births with 7 (8.6%) born preterm, one (1.2%) major congenital malformation of an atrial septum defect and 10 (12.3%) minor congenital malformations were reported. Disease course was stable in most women with three (3.4%) relapses occurring in pregnancy in 86 women with completed pregnancy follow-up and four (5.1%) postpartum in 79 women with at least 3 months postpartum follow-up

Conclusions:
The cohort showed excellent disease control during pregnancy and few relapses postpartum, without the phenomenon of rebound. Our data adds useful information on pregnancies with generally healthy newborns after CLAD treatment but is limited by the small sample size. It is important to counsel women to avoid pregnancies within 6-months after last CLAD intake and use effective contraception
10.1212/WNL.0000000000211117
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