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

Abstract

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.

Keywords: Brivaracetam; Cognitive performance; EpiTrack; Epilepsy; Focal-onset seizure; Health-related quality of life; Noninterventional; Observational; Real-world.

Fig. 1

Clinically meaningful^a changes in QOLIE-31-P scores from baseline to 6 and 12 months in the FAS (a) and mFAS (b). FAS Full Analysis Set, m month, mFAS Modified Full Analysis Set, QoL quality of life, QOLIE-31-P Patient Weighted Quality of Life in Epilepsy Inventory-Form 31. ^aClinically meaningful thresholds were defined according to Borghs et al. [21]: total score 5.19, seizure worry 7.42, overall QoL 6.42, emotional well-being 4.76, energy/fatigue 5.25, cognitive functioning 5.34, medication effects 5.00, social functioning 3.95

Fig. 2

Clinical Global Impression of Change at 6 and 12 months in the FAS (a) and mFAS (b). FAS Full Analysis Set, mFAS Modified Full Analysis Set. “Clinically relevant” is as interpreted by participating physicians in the clinical routine

Fig. 3

Patient’s Global Impression of Change at 6 and 12 months in the FAS (a) and mFAS (b). FAS Full Analysis Set, mFAS Modified Full Analysis Set. “Clinically relevant” is as interpreted by participating physicians in the clinical routine

Fig. 4

EpiTrack® outcomes: significant changes^a in EpiTrack® score from baseline to 6 and 12 months (a); EpiTrack® cognitive performance categories^b at baseline, 6 months, and 12 months (b); EpiTrack® cognitive performance subtest scores (mean)^c at baseline and 6 months (c) and at baseline and 12 months (d) (FAS). BL baseline, FAS Full Analysis Set. ^aImprovement was defined as an increase in score of ≥ 4 points; no change was defined as a change in score of − 2 to 3 points inclusive; worsening was defined as a change in score of at least − 3 points. ^bExcellent: ≥ 39 points; average: 32–38 points; mildly impaired: 29–31 points; significantly impaired: ≤ 28 points. Out-of-plausible-range individual point scores were set to missing before summarizing and deriving the data. ^cPresented are the point score categories (after raw scores were translated into points). Out-of-plausible-range individual point scores were set to missing before summarizing and deriving the data. Each of the EpiTrack® subtests was collected in 143–145 patients at baseline, 84–85 patients at 6 months, and 61 patients at 12 months