Abstract Details

Title Pregnancy Outcomes Following Exposure to Lacosamide: Prospective Data from Spontaneous and Solicited Reports

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P4 - Poster Session 4 (11:45 AM-12:45 PM)

Poster/Presentation
Number 1-011

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.

Authors/Disclosures
Paula E. Voinescu, MD (Brigham and Women'S Hospital) PRESENTER	The institution of Dr. Voinescu has received research support from Epilepsy Foundation of New England. The institution of Dr. Voinescu has received research support from BWH - Connors Center. The institution of an immediate family member of Dr. Voinescu has received research support from American Epilepsy Society. Dr. Voinescu has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Phillipines League Against Epilepsy. Dr. Voinescu has received personal compensation in the range of $500-$4,999 for serving as a PhD Opponent with University of Bergen, Norway. Dr. Voinescu has a non-compensated relationship as a Board Member and Chair with My Epilepsy Story that is relevant to AAN interests or activities. Dr. Voinescu has a non-compensated relationship as a Speaker with Epilepsy Foundation that is relevant to AAN interests or activities. Dr. Voinescu has a non-compensated relationship as a Grant Reviewer with American Epilepsy Society that is relevant to AAN interests or activities. Dr. Voinescu has a non-compensated relationship as a Member of Scientific Advisory Committee with North American AED Pregnancy Registry that is relevant to AAN interests or activities.
Piero Perucca, MD (Melbourne Brain Centre)	The institution of Dr. Perucca has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Perucca has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Epilepsia Open. Dr. Perucca has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Epilepsia Open. The institution of Dr. Perucca has received research support from NHMRC. The institution of Dr. Perucca has received research support from Epilepsy Foundation. The institution of Dr. Perucca has received research support from Monash University. The institution of Dr. Perucca has received research support from Sanming Project Grant, Shenzhen government. The institution of Dr. Perucca has received research support from Medical Research Future Fund. The institution of Dr. Perucca has received research support from Norman Beischer Medical Research Foundation. The institution of Dr. Perucca has received research support from NHMRC. The institution of Dr. Perucca has received research support from Austin Medical Research Foundation. The institution of Dr. Perucca has received research support from The University of Melbourne and The University of Bonn. The institution of Dr. Perucca has received research support from Austin Medical Research Foundation . Dr. Perucca has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Eisai. Dr. Perucca has received personal compensation in the range of $500-$4,999 for serving as a Speaker with UCB. Dr. Perucca has received personal compensation in the range of $500-$4,999 for serving as a Speaker with LivaNova. Dr. Perucca has a non-compensated relationship as a Member, Central Project Commission with EURAP-International Registry of Antiepileptic Drugs and Pregnancy that is relevant to AAN interests or activities. Dr. Perucca has a non-compensated relationship as a Member, Advisory Board with Raoul Wallenberg Australian Pregnancy Register of Antiepileptic Drugs that is relevant to AAN interests or activities.
Dimitrios Bourikas (UCB)	Dr. Bourikas has nothing to disclose.
Lata Vadlamudi, MD, MBBS (Royal Brisbane and Women'S Hospital)	The institution of Dr. Vadlamudi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. The institution of Dr. Vadlamudi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai.
Daya Chellun	No disclosure on file
Thomas Kumke	No disclosure on file
Konrad Werhahn	Konrad Werhahn has received personal compensation for serving as an employee of UCB Pharma. Konrad Werhahn has stock in UCB Pharma.
Bettina Schmitz	No disclosure on file

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