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Introduction <p>This analysis aimed to evaluate patient-related outcomes for health-related quality of life (HRQoL) and cognitive performance in patients (≥ 16&#xa0;years) with focal-onset seizures (FOS), with/without focal to bilateral tonic–clonic seizures, after initiating adjunctive brivaracetam (BRV) in routine clinical practice.</p> Methods <p>A 12-month, prospective, real-world, noninterventional study in nine European countries (EP0077/NCT02687711) was performed. BRV was prescribed per clinical practice and the European Summary of Product Characteristics. The outcomes evaluated were the Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P), the Clinical and the Patient’s Global Impression of Change (CGIC and PGIC, respectively), and EpiTrack<sup>®</sup>. EpiTrack<sup>®</sup> scores were categorized into cognitive performance categories (excellent: ≥ 39 points; average: 32–38 points; mildly impaired: 29–31 points; significantly impaired: ≤ 28 points). The change in EpiTrack<sup>®</sup> score was evaluated [improvement: increase in score of ≥ 4 points; no change: change in score  of − 2 to 3 points (inclusive); worsening: change in score of at least − 3 points].</p> Results <p>Full Analysis Set: 541 patients. 46.6% of patients reported a clinically meaningful improvement in QOLIE-31-P total score from baseline to 12&#xa0;months; the mean change in total score was + 6.2 points (<i>N</i> = 103). Per CGIC (<i>N</i> = 142) and PGIC (<i>N</i> = 148), respectively, 69.0% and 62.8% of patients had improved in overall condition at 12&#xa0;months versus baseline, while 3.5% and 8.1% had worsened. EpiTrack<sup>®</sup> categories at 12&#xa0;months versus baseline showed improved cognitive performance [baseline (<i>N</i> = 142): significantly impaired 49.3%, mildly impaired 14.8%, average 33.1%, excellent 2.8%; 12&#xa0;months (<i>N</i> = 61): significantly impaired 36.1%, mildly impaired 4.9%, average 52.5%, excellent 6.6%]. At 12&#xa0;months, 67.2% of patients showed no significant change from baseline in EpiTrack<sup>®</sup> score, 23.0% had improved, and 9.8% had worsened (<i>N</i> = 61).</p> Conclusion <p>In patients with predominantly difficult-to-treat FOS, BRV add-on was associated with good HRQoL and cognitive functioning. Cognitive functioning remained stable for 12&#xa0;months after BRV initiation in most patients; nearly one-quarter experienced significant improvements. At 12&#xa0;months, 46.6% of patients reported clinically meaningful HRQoL improvements, and most showed an improved overall condition.</p>

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Health-Related Quality of Life and Cognitive Performance During 12-Month Adjunctive Brivaracetam Treatment in Patients with Focal-Onset Seizures: A Prospective, Observational Study in Europe

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  • 发表日期：

    2025年2月20日

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  • Eduardo Rubio-Nazabal,
  • Marian Majoie,
  • Anne-Liv Schulz,
  • Fiona Brock,
  • Iryna Leunikava,
  • Dimitrios Bourikas,
  • Bernhard J. Steinhoff

摘要

Introduction

This analysis aimed to evaluate patient-related outcomes for health-related quality of life (HRQoL) and cognitive performance in patients (≥ 16 years) with focal-onset seizures (FOS), with/without focal to bilateral tonic–clonic seizures, after initiating adjunctive brivaracetam (BRV) in routine clinical practice.

Methods

A 12-month, prospective, real-world, noninterventional study in nine European countries (EP0077/NCT02687711) was performed. BRV was prescribed per clinical practice and the European Summary of Product Characteristics. The outcomes evaluated were the Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P), the Clinical and the Patient’s Global Impression of Change (CGIC and PGIC, respectively), and EpiTrack®. EpiTrack® scores were categorized into cognitive performance categories (excellent: ≥ 39 points; average: 32–38 points; mildly impaired: 29–31 points; significantly impaired: ≤ 28 points). The change in EpiTrack® score was evaluated [improvement: increase in score of ≥ 4 points; no change: change in score  of − 2 to 3 points (inclusive); worsening: change in score of at least − 3 points].

Results

Full Analysis Set: 541 patients. 46.6% of patients reported a clinically meaningful improvement in QOLIE-31-P total score from baseline to 12 months; the mean change in total score was + 6.2 points (N = 103). Per CGIC (N = 142) and PGIC (N = 148), respectively, 69.0% and 62.8% of patients had improved in overall condition at 12 months versus baseline, while 3.5% and 8.1% had worsened. EpiTrack® categories at 12 months versus baseline showed improved cognitive performance [baseline (N = 142): significantly impaired 49.3%, mildly impaired 14.8%, average 33.1%, excellent 2.8%; 12 months (N = 61): significantly impaired 36.1%, mildly impaired 4.9%, average 52.5%, excellent 6.6%]. At 12 months, 67.2% of patients showed no significant change from baseline in EpiTrack® score, 23.0% had improved, and 9.8% had worsened (N = 61).

Conclusion

In patients with predominantly difficult-to-treat FOS, BRV add-on was associated with good HRQoL and cognitive functioning. Cognitive functioning remained stable for 12 months after BRV initiation in most patients; nearly one-quarter experienced significant improvements. At 12 months, 46.6% of patients reported clinically meaningful HRQoL improvements, and most showed an improved overall condition.