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Introduction <p>This trial evaluated long-term safety, tolerability, and maintenance of efficacy of adjunctive brivaracetam (BRV) in Japanese and Chinese patients aged ≥ 16&#xa0;years with focal-onset seizures (FOS).</p> Methods <p>Interim analysis of data from EP0085 (NCT03250377), a long-term follow-up trial of adjunctive BRV 50–200&#xa0;mg/day in Japanese and Chinese patients. Post hoc analyses assessed efficacy for 12- and 24-month completers and BRV retention.</p> Results <p>At data cutoff (June 1, 2023), 207 patients had enrolled; of these, 157 (75.8%) were ongoing and 50 (24.2%) had discontinued. Overall, 137 patients were 12-month completers and 63 were 24-month completers. Mean age was 36.7&#xa0;years and 107 (51.7%) patients were female (100 [48.3%] male). Mean duration of epilepsy was 17.16&#xa0;years. At data cutoff, total duration of BRV exposure was 378.5 patient-years. Mean duration of BRV exposure was 667.8&#xa0;days (median 427.0&#xa0;days), with a median modal dose of 200.0&#xa0;mg/day (range 25.0–200.0&#xa0;mg/day). Kaplan–Meier-estimated BRV retention rates at 12, 24, and 36&#xa0;months were 85%, 76%, and 68%, respectively. Treatment-emergent adverse events (TEAEs) were reported by 184 (88.9%) patients, drug-related TEAEs by 60 (29.0%), serious TEAEs by 29 (14.0%), and 8 (3.9%) discontinued as a result of TEAEs. Median FOS frequency/28&#xa0;days decreased from 7.59 during baseline to 4.11 during the evaluation period. For the overall evaluation period, 12-month, and 24-month completers, median percentage reductions from baseline in FOS frequency/28&#xa0;days were 42.4%, 44.0%, and 38.9%, respectively, and 50% responder rates were 46.4%, 46.7%, and 38.1%.</p> Conclusion <p>Based on this interim and post hoc analysis, long-term adjunctive BRV was well tolerated and efficacious in Japanese and Chinese patients with FOS. The efficacy response was maintained over time in those completing 12 and 24&#xa0;months of trial participation. Overall, 68% of patients remained on BRV treatment for 3&#xa0;years.</p> Trial Registration <p>ClinicalTrials.gov NCT03250377.</p> <p>Graphical abstract available for this article.</p> Graphical Abstract <p></p>

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Safety, Tolerability, and Efficacy of Adjunctive Brivaracetam in Japanese and Chinese Patients with Focal-Onset Seizures: Interim Analysis of a Phase 3 Open-Label Extension Trial

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  • 发表日期：

    2025年6月23日

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  • Ayataka Fujimoto,
  • Bing Qin,
  • Dimitrios Bourikas,
  • Najla Dickson,
  • Brian Moseley,
  • Tomonobu Sano,
  • Tadaharu Soma,
  • Weiwei Sun,
  • Jun Watanabe,
  • Dong Zhou,
  • Yushi Inoue

摘要

Introduction

This trial evaluated long-term safety, tolerability, and maintenance of efficacy of adjunctive brivaracetam (BRV) in Japanese and Chinese patients aged ≥ 16 years with focal-onset seizures (FOS).

Methods

Interim analysis of data from EP0085 (NCT03250377), a long-term follow-up trial of adjunctive BRV 50–200 mg/day in Japanese and Chinese patients. Post hoc analyses assessed efficacy for 12- and 24-month completers and BRV retention.

Results

At data cutoff (June 1, 2023), 207 patients had enrolled; of these, 157 (75.8%) were ongoing and 50 (24.2%) had discontinued. Overall, 137 patients were 12-month completers and 63 were 24-month completers. Mean age was 36.7 years and 107 (51.7%) patients were female (100 [48.3%] male). Mean duration of epilepsy was 17.16 years. At data cutoff, total duration of BRV exposure was 378.5 patient-years. Mean duration of BRV exposure was 667.8 days (median 427.0 days), with a median modal dose of 200.0 mg/day (range 25.0–200.0 mg/day). Kaplan–Meier-estimated BRV retention rates at 12, 24, and 36 months were 85%, 76%, and 68%, respectively. Treatment-emergent adverse events (TEAEs) were reported by 184 (88.9%) patients, drug-related TEAEs by 60 (29.0%), serious TEAEs by 29 (14.0%), and 8 (3.9%) discontinued as a result of TEAEs. Median FOS frequency/28 days decreased from 7.59 during baseline to 4.11 during the evaluation period. For the overall evaluation period, 12-month, and 24-month completers, median percentage reductions from baseline in FOS frequency/28 days were 42.4%, 44.0%, and 38.9%, respectively, and 50% responder rates were 46.4%, 46.7%, and 38.1%.

Conclusion

Based on this interim and post hoc analysis, long-term adjunctive BRV was well tolerated and efficacious in Japanese and Chinese patients with FOS. The efficacy response was maintained over time in those completing 12 and 24 months of trial participation. Overall, 68% of patients remained on BRV treatment for 3 years.

Trial Registration

ClinicalTrials.gov NCT03250377.

Graphical abstract available for this article.

Graphical Abstract