Neda Ebrahimi1, Sandra Herbstritt2, Ralph Gold2, Lilyana Amezcua3, Gideon Koren4, Kerstin Hellwig2. 1. Motherisk Program, Division of Pharmacology and Toxicology, The Hospital for Sick Children, Canada/University of Toronto, Leslie Dan Faculty of Pharmacy, Canada neda.ebrahimi@sickkids.ca. 2. St. Josef Hospital, Faculty of Medicine, Ruhr University, Germany. 3. MS Comprehensive Care Center USC, Keck School of Medicine, USA. 4. Motherisk Program, Division of Pharmacology and Toxicology, The Hospital for Sick Children, Canada/University of Toronto, Leslie Dan Faculty of Pharmacy, Canada.
Abstract
BACKGROUND: Safety data on first-trimester natalizumab exposure are scarce, as natalizumab is usually withdrawn three months before pregnancy.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.
BACKGROUND: Safety data on first-trimester natalizumab exposure are scarce, as natalizumab is usually withdrawn three months before pregnancy.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.
Authors: Ralf Gold; Dusan Stefoski; Krzysztof Selmaj; Eva Havrdova; Christopher Hurst; Joan Holman; Belen Tornesi; Surekha Akella; Peter McCroskery Journal: Neurol Ther Date: 2016-07-13