Authors :
Presenting Author: Xintong Wu, MD – West China Hospital of Sichuan University
Dong Wang, MD – Xi'an Children’s Hospital; Shuang Wang, MD – The Second Affiliated Hospital Zhejiang University School of Medicine; Anne-Liv Schulz, MD – UCB Pharma, Monheim am Rhein, Germany; Yuefeng Yu, MPH – UCB Pharma, Shanghai, China; Herve Besson, PhD – UCB Pharma, Breda, The Netherlands; Sijie Chen, PhD – UCB Pharma, Shanghai, China; Dong Zhou, MD – West China Hospital of Sichuan University; Yuwu Jiang, MD – Peking University First Hospital
Rationale:
A multicenter, prospective, noninterventional, post-marketing surveillance study (EP0144) to evaluate safety and effectiveness of lacosamide (LCM) is ongoing in mainland China. Here, we present results in monotherapy patients from
the first interim analysis.
Methods:
Adult and pediatric epilepsy patients ≥4 years with focal-onset seizures (FOS) who were newly prescribed or had already received LCM treatment for up to 14 days before enrollment were recruited.
During the 24-week observation period, clinical physicians treated patients with flexible LCM dosage according to real world clinical practice and were free to add or withdraw any concomitant medication for optimization of treatment. Patients were identified
as monotherapy patients if they started LCM monotherapy no later than one month after LCM initiation and stayed on it until the last visit. Safety and effectiveness were evaluated.
Results:
As of October 2022, 187 enrolled patients were identified as monotherapy with 42 patients (22.5%) completed, 135 patients (72.2%) ongoing and 10 patients (5.3%) discontinued treatment. Mean (SD) age in the monotherapy group
was 13.3 (11.5) years, and 148 patients (79.1%) were pediatric patients (Table 1). A total of 16 patients (8.6%) had received prior anti-seizure medications (ASMs) including six patients (3.2%) who received 1 ASM at baseline and converted to LCM monotherapy
at Visit 2. Total exposure of LCM was 48.59 patient‑years, and mean (SD) duration of exposure to LCM was 94.9 (60.3) days. Mean (SD) initial and maintenance doses of LCM were 64.02 (33.68) mg/day (range: 10.0mg/day to 200.0mg/day) and 133.94 (64.53)mg/day (range: 10.0mg/day to 300.0mg/day), respectively. Twenty-three patients (12.3%) experienced a total of 30 treatment-emergent adverse events (TEAEs), the most common being upper respiratory tract infection (n=5, 2.7%) and vitamin D deficiency (n=4, 2.1%). All TEAEs were mild (95.7%) or moderate (4.3%) in intensity (Table 2). Seven of the 23 patients experienced a TEAE considered related to LCM per the investigator. Three patients (1.6%) experienced serious adverse events (SAEs) including cardiomegaly, upper respiratory tract infection and convulsion (one patient each). No TEAE leading to withdrawal or death was reported. Among the 42 patients who completed the 24‑week observation period, the seizure‑freedom rates from baseline to Week 12 and Week 24 were 76.2% and 71.4%, respectively. The proportion of 50% responders was 92.9% at both Week 12 and Week 24. A high LCM retention rate was achieved at Week 12 (90.3%) and Week 24 (84.0%). A total of 39 of 42 patients were reported as improved on the Clinical Global Impression of Change assessments (CGIC) after LCM treatment at the Termination Visit.
Conclusions:
In this interim analysis, low doses of LCM monotherapy show favorable safety/tolerability in real world clinical practice in China. With approximately 80% pediatric patients, no new safety concerns were identified with LCM monotherapy. Effectiveness results align with clinical efficacy benefits of LCM monotherapy demonstrated in other studies.
Funding:
UCB Pharma-sponsored.