Glatiramer acetate during early pregnancy: A prospective cohort study.

BACKGROUND: Only limited data are available on whether glatiramer acetate exposure during pregnancy has an effect on perinatal outcome. OBJECTIVE: To determine the effect of glatiramer acetate exposure during pregnancy on pregnancy outcomes in women with multiple sclerosis. METHODS: We compared the outcome of pregnancies of women with multiple sclerosis exposed to glatiramer acetate with pregnancies unexposed to disease-modifying therapies. Women were enrolled into the German Multiple Sclerosis and Pregnancy registry. A standardized questionnaire was administered during pregnancy and postpartum. Detailed information on course of multiple sclerosis and pregnancy, concomitant medications, labor, delivery, and outcome of pregnancy was obtained. RESULTS: We collected data on 246 multiple sclerosis pregnancies, 151 exposed to glatiramer acetate and 95 unexposed to disease-modifying therapies during pregnancy. Three (2.2%) congenital anomalies occurred in the exposed and 6 (6.7%) in the control group. We did not observe an increase in other adverse pregnancy or delivery outcomes including spontaneous abortions, preterm birth, Cesarean sections, or reduced birth weight in the exposed group. CONCLUSION: Our data provide further evidence that glatiramer acetate exposure during the first trimester of pregnancy appears safe and without teratogenic effect. These findings provide important additive knowledge to better counsel women with multiple sclerosis in planning a pregnancy.

Exclusive Breastfeeding and the Effect on Postpartum Multiple Sclerosis Relapses.

IMPORTANCE: Women with multiple sclerosis (MS) experience an elevated risk of relapse after giving birth. The effect of exclusive breastfeeding on postpartum risk of MS relapse is unclear. OBJECTIVES: To determine the effect of exclusive breastfeeding on postpartum risk of MS relapse and to investigate the effect of introducing supplemental feedings on that risk. DESIGN, SETTING, AND PARTICIPANTS: Data on 201 pregnant women with relapsing-remitting MS were collected prospectively from January 1, 2008, to June 30, 2012, with 1 year follow-up post partum in the nationwide German MS and pregnancy registry. The effect of the intention to breastfeed exclusively (no regular replacement of breastfeeding meals with supplemental feedings) for at least 2 months compared with nonexclusive breastfeeding (partial or no breastfeeding) on the first postpartum MS relapse, using Cox proportional hazards regression model adjusted for age and disease activity, before and during pregnancy was analyzed. Data analysis was performed from August 30, 2013, to May 25, 2015. EXPOSURE: Exclusive breastfeeding defined as at least 2 months of breastfeeding without regular replacement of any meal by supplemental feeding. MAIN OUTCOME AND MEASURE: First postpartum MS relapse. RESULTS: Of 201 women, 120 (59.7%) intended to breastfeed exclusively for at least 2 months and 81 (40.3%) breastfed and included supplemental feeding (42 [20.9%]) or did not breastfeed (39 [19.4%]). Thirty-one women (38.3%) who did not breastfeed exclusively had a relapse within the first 6 months post partum compared with 29 women (24.2%) who intended to breastfeed exclusively for at least 2 months (unadjusted hazard ratio, 1.80; 95% CI, 1.09-2.99; P = .02; adjusted hazard ratio, 1.70; 95% CI, 1.02-2.85; P = .04). The time to first postpartum relapse after the introduction of supplemental feedings did not differ significantly between women who previously breastfed exclusively and those who did not (P = .60). CONCLUSIONS AND RELEVANCE: The findings of this study suggest that exclusive breastfeeding is a modestly effective MS treatment with a natural end date. Our study provides further evidence that women with MS who breastfeed exclusively should be supported to do so since it does not increase the risk of postpartum relapse.

Pregnancy and fetal outcomes following natalizumab exposure in pregnancy. A prospective, controlled observational study.

BACKGROUND: Safety data on first-trimester natalizumab exposure are scarce, as natalizumab is usually withdrawn three months before pregnancy. OBJECTIVE: The objective of this paper is to investigate the fetal safety of exposure to natalizumab (Tysabri(®)) during the first trimester of pregnancy using disease-matched (DM) and healthy control (HC) comparison groups. METHODS: A total of 101 German women with RRMS exposed to natalizumab during the first trimester of pregnancy were identified. Birth outcomes in the exposed group were compared to a DM group (N = 78) with or without exposure to other disease-modifying drugs, and an HC group (N = 97). RESULTS: A total of 77, 69 and 92 live births occurred in the Exposed, DM and HC groups, respectively. The rates of major malformations (p = 0.67), low birth weight (<2500 grams) (p = 1.0) and premature birth (p = 0.37) did not differ among groups. Higher miscarriage rates (p = 0.002) and lower birth weights (p = 0.001) occurred among the Exposed and DM groups, as compared to the HC; however, there was no significant difference between the Exposed and DM groups. CONCLUSION: Exposure to natalizumab in early pregnancy does not appear to increase the risk of adverse pregnancy outcomes in comparison to a DM group not exposed to natalizumab.

Natalizumab use during the third trimester of pregnancy.

IMPORTANCE: Natalizumab reduces multiple sclerosis relapses very effectively; however, severe disease activity may return once natalizumab treatment is withdrawn, as recommended during pregnancy. Sometimes restarting natalizumab treatment may be the best option for the mother, but the consequences for the infant are unknown. Except for a few single case reports, to our knowledge, comprehensive data about third-trimester natalizumab exposure are scant. OBSERVATIONS: In a case series of 12 women with 13 pregnancies and highly active multiple sclerosis who were treated with natalizumab during their third trimester of pregnancy, we assessed the clinical and laboratory effects on the newborns. We observed mild to moderate hematologic alterations in 10 of 13 infants including thrombocytopenia and anemia. In a subsample of 5 mother-child pairs, we analyzed natalizumab levels in the umbilical cord blood. Natalizumab was detectable in all 5 newborns. CONCLUSION AND RELEVANCE: Natalizumab can be a therapeutic option in patients with highly active multiple sclerosis during pregnancy. We recommend that a pediatrician be available at the time of delivery to evaluate for potential complications of anemia and thrombocytopenia in newborns exposed to natalizumab during the third trimester.