Pregnancy Outcomes Following Exposure to Lacosamide: Prospective Data from Spontaneous and Solicited Reports
Piero Perucca1, Dimitrios Bourikas2, P Emanuela Voinescu3, Lata Vadlamudi4, Daya Chellun2, Thomas Kumke2, Konrad J. Werhahn2, Bettina Schmitz5
1The University of Melbourne and Bladin-Berkovic Comprehensive Epilepsy Program, Austin Health, 2UCB Pharma, 3Brigham and Women's Hospital, Harvard Medical School, 4University of Queensland Centre for Clinical Research (UQCCR), Royal Brisbane and Women’s Hospital, 5Vivantes Humboldt-Klinikum
Objective:
Evaluate fetal outcomes of lacosamide (LCM)-exposed pregnancies.
Background:
In pregnancy, risks of uncontrolled epileptic seizures to the mother and fetus need to be balanced against potential teratogenic effects of antiseizure medications (ASMs). Data are limited on pregnancy outcomes among patients taking LCM.
Design/Methods:
Analysis of all prospective reports (in the UCB Pharma global safety database [cutoff 31 Aug 2021]) of exposure to LCM during pregnancy from spontaneous sources (routine clinical settings) or solicited reports from interventional clinical studies and non-interventional post-marketing studies.
Results:
213 pregnancy cases with known outcomes were identified; 202 were maternal exposure pregnancies, with 204 reported pregnancy outcomes (2 twin pregnancies on LCM polytherapy). During pregnancy, 21.8% (44/202) patients received LCM monotherapy, and 78.2% (158/202) received polytherapy. Mean age at start of pregnancy was 29.0 and 28.2 years for patients on LCM monotherapy and polytherapy, respectively. Overall, 88.6% (39/44) patients on LCM monotherapy and 90.5% (143/158) on polytherapy received LCM during the 1st trimester (mean maximum dose of 352.9 and 297.6 mg/day, respectively). 57.0% (90/158) patients on LCM polytherapy were on 1 concomitant ASM and 41.8% (66/158) were on ≥2 concomitant ASMs (2 unknown). Among pregnancy outcomes with maternal exposure to LCM as monotherapy/polytherapy, live births were numerically higher (84.1% [37/44]/76.3% [122/160]), and all abortions were numerically lower (15.9% [7/44]/22.5% [36/160]). Congenital malformations were reported in 2.3% (1/44) and 6.9% (11/160) of pregnancy outcomes (based on all known outcomes) with maternal exposure to LCM monotherapy and polytherapy, respectively; of the live births, preterm delivery was reported in 10.8% (4/37) and 9.0% (11/122); small for gestational age was reported in 2.7% (1/37) and 2.5% (3/122); low birth weight was reported in 13.5% (5/37) and 8.2% (10/122).
Conclusions:
Most LCM-exposed pregnancies resulted in healthy live births. Additional data are needed to fully evaluate the safety of LCM in pregnancy.