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Abstracts

Safety and Effectiveness of Lacosamide in Chinese Patients with Focal-onset Seizures: A Multicenter Prospective Noninterventional Drug Intensive Monitoring Study

Abstract number : 2.37
Submission category : 7. Anti-seizure Medications / 7B. Clinical Trials
Year : 2024
Submission ID : 754
Source : www.aesnet.org
Presentation date : 12/8/2024 12:00:00 AM
Published date :

Authors :
Presenting Author: Xintong Wu, MD – West China Hospital, Sichuan University

Taoyun Ji, MD – Peking University First Hosiptal
Shuang Wang, MD – The 2nd Affiliated Hospital of Zhejiang University, Hangzhou, China
Dong Wang, MD – Xi'an Children's Hospital, Xi’an, China
Qun Wang, MD – Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China
Shuizhen Zhou, MD – Children's Hospital of Fudan University, Shanghai, China
Dan Sun, MD – Wuhan children's Hospital - Neurology, Wuhan, China
Jing Peng, MD – Xiangya Hospital of Zhongnan University, Changsha, China
Weiping Liao, MD – The Second Affiliated Hospital of Guangzhou Medical Collage, Guangzhou, China
Xiaoyan Xu, MSc – UCB Pharma, Shanghai, China
Tanja Heidbrede, PhD – UCB BioSciences, Monheim am Rhein, Germany
He Zhao, MD – UCB Pharma, Shanghai, China
Dong Zhou, MD – West China Hospital, Sichuan University
Yuwu Jiang, MD, PhD – Peking University First Hospital, Beijing, China

Rationale: A multicenter, prospective noninterventional, post-marketing surveillance study (EP0144) aimed to evaluate the safety and effectiveness of lacosamide (LCM) in Chinese epilepsy patients.


Methods: Epilepsy patients aged ≥ 4 years with focal-onset seizures (FOS) who were newly prescribed or had received LCM treatment for up to 14 days before enrollment were recruited. Over a 24-week observation period, physicians adjusted LCM dosages according to clinical practice and could adjust concomitant medications as needed. Patients who started LCM monotherapy no later than 1 month after LCM initiation and stayed on it until the last visit were identified as monotherapy patients. Safety and effectiveness were evaluated.


Results: 866 patients were enrolled in the Safety Set (SS) and 821 in the Full Analysis Set (FAS). The study enrolled a patient population with an average age of 21.2 years; more than half (56.2%) were pediatric patients who were over-represented in the monotherapy group (78.9%) vs. adjunctive group (37.9%). All patients experienced at least 1 FOS and the mean FOS seizure frequency was 4.03 during the Baseline Period of 12 weeks prior to the first dose of LCM. Mean LCM treatment duration during observation period was 156.3 days, with a total exposure of 370.69 patient-years. Treatment-emergent adverse events (TEAEs) were reported in 21.6% of patients, with the most common being upper respiratory tract infection (3.9%). Incidence of serious adverse events (SAEs), adverse drug reaction (ADR) and serious ADRs were 2.8%, 7.2% and 0.3%, respectively. 14 patients (1.6%) discontinued treatment due to TEAEs, with dizziness (0.5%) and rash (0.3%) being the most common reasons for discontinuation. The retention rate calculated based on SS was 90.0% at Week 12 and 86.9% at Week 24. An analysis of seizure-free status based on FAS showed that 55.2% of patients achieved seizure freedom at Week 12 and 47.6% were seizure free until Week 24. The percentages of 50% responders and 75% responders were high and remained stable throughout the study (Table 2). From baseline to last assessment, most patients (90.5%) showed improvement in Clinical Global Impression of Change (CGIC) scores. Quality of life remained stable or slightly improved in adult patients as measured by Patient Weighted Quality of Life in Epilepsy Inventory – Form 31 (QOLIE-31-P) and was consistently high in pediatric patients as measured by Pediatric Quality of Life Inventory (PedsQL). Both anxiety levels [measured by the Generalized Anxiety Disorder-7 (GAD-7)] and depressive symptoms [measured by the Chinese Neurological Disorders Depression Inventory Epilepsy (C-NDDI-E)] decreased slightly from baseline.


Conclusions: LCM demonstrated a favorable safety/tolerability and effectiveness profile in Chinese epilepsy patients with FOS in a real-world setting, consistent with previous studies and product labeling.


Funding: UCB Pharma-sponsored

Anti-seizure Medications