title: Health-related quality of life in double-blind Phase III studies of brivaracetam as adjunctive therapy of focal seizures: A pooled, post-hoc analysis.
abstract: The effect of adjunctive brivaracetam on health-related quality of life (HRQoL) was assessed in a post-hoc analysis using pooled data from three randomized, double-blind, placebo-controlled Phase III studies in patients with refractory focal seizures (NCT00490035, NCT00464269, and NCT01261325).
  
  
  
  The Patient-Weighted Quality of Life in Epilepsy Questionnaire (QOLIE-31-P) was completed at randomization, and weeks 4, 8 (in two of three studies), and 12 (end of the treatment period). Mean change from baseline to week 12 or early discontinuation, and percentage of patients with clinically meaningful improvement were reported for the placebo and brivaracetam 50, 100, and 200mg/day groups.
  
  
  
  At baseline, mean QOLIE-31-P scores were similar between treatment groups. At week 12 or early discontinuation, mean (standard deviation) changes from baseline in QOLIE-31-P total score were 2.8 (12.7), 3.0 (14.0), 2.4 (14.0), and 3.0 (12.1) points for the placebo and brivaracetam 50, 100, and 200mg/day groups, respectively, indicating HRQoL improved slightly over time during the treatment period, but was similar for placebo and brivaracetam groups. All subscale score changes were positive, indicating stable or improved HRQoL over time. The brivaracetam 100 and 200mg/day groups showed the largest differences compared with placebo in Seizure Worry subscale scores (7.3 and 8.8 vs. 5.0 points). Approximately 40% of patients had improvements in QOLIE-31-P scores beyond the Minimal Important Change (MIC) thresholds. The subgroup of ≥50% focal seizure frequency responders had higher improvements for all treatment arms and all subscales than for those in the overall pooled population.
  
  
  
  In this post-hoc analysis, adjunctive brivaracetam treatment was shown to be associated with stable or improving overall HRQoL over time, similar to placebo, with modest improvements in subscales sensitive to efficacy, and no deterioration in subscales sensitive to tolerability. These results reflect the known efficacy and tolerability profile of brivaracetam.
authors.affiliation: Department of General Epileptology, Bethel Epilepsy Centre, Mara Hospital, Maraweg 21, D-33617 Bielefeld, Germany. Electronic address: christian.brandt@mara.de.
authors.forename: Christian
authors.initials: C
authors.lastname: Brandt
authors.affiliation: UCB Pharma, 208 Bath Road, Slough, Berkshire SL1 3WE, UK. Electronic address: simon.borghs@ucb.com.
authors.forename: Simon
authors.initials: S
authors.lastname: Borghs
authors.affiliation: UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: sami.elmoufti@ucb.com.
authors.forename: Sami
authors.initials: S
authors.lastname: Elmoufti
authors.affiliation: UCB Pharma, Alfred-Nobel-Strasse 10, 40789 Monheim, Germany. Electronic address: knut.mueller@ucb.com.
authors.forename: Knut
authors.initials: K
authors.lastname: Mueller
authors.affiliation: UCB Pharma, 1950 Lake Park Drive South East, Smyrna, GA 30080, USA. Electronic address: rebecca.townsend@ucb.com.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Townsend
authors.affiliation: 57, rue de Lyon, 89200 Avallon, France. Electronic address: cdelaloge@hotmail.fr.
authors.forename: Christine
authors.initials: C
authors.lastname: de la Loge
mesh_terms: D000328:Adult; D000927:Anticonvulsants / Q000008:administration & dosage*; D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011760:Pyrrolidinones / Q000008:administration & dosage*; D011788:Quality of Life / Q000523:psychology*; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000927:Anticonvulsants; D011760:Pyrrolidinones; C482793:brivaracetam
keywords: Adjunctive; Brivaracetam; Focal seizures; QOLIE-31; Refractory epilepsy; Seizure Worry