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Treatment with brivaracetam has no apparent long-term effects on body weight in pediatric patients with epilepsy
Florin I Floricel1, Paula E Reichel2, Najla Dickson3
1UCB Pharma, Monheim am Rhein, Germany.
Insights
Long-term brivaracetam (BRV) treatment showed no detrimental effects on body weight or BMI in children with epilepsy. This antiseizure medication is well-tolerated, with low incidences of appetite or weight-related side effects.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
- Epilepsy Management
Background:
- Antiseizure medications (ASMs) can impact appetite and body weight, a critical concern in pediatric populations.
- Brivaracetam (BRV) is an ASM used for epilepsy treatment.
- Understanding the long-term effects of BRV on growth parameters is essential for pediatric epilepsy care.
Purpose of the Study:
- To evaluate the long-term effects of brivaracetam (BRV) on body weight and body mass index (BMI) in children with epilepsy.
- To assess the incidence of treatment-emergent adverse events (TEAEs) related to appetite and weight changes.
- To consider the influence of pre-existing medical conditions and concomitant ASMs on BRV's effect on weight.
Main Methods:
- Post hoc analysis of a long-term, open-label trial involving pediatric patients (1 month to <17 years) treated with BRV for ≥6 months.
- Evaluation of body weight and BMI z-score growth curves over time.
- Analysis of medical history (gastrointestinal, metabolic/nutritional disorders) and concomitant ASMs.
Main Results:
- The study included 209 pediatric patients, with most having focal-onset seizures.
- The majority of patients maintained their z-score curves for body weight and BMI during BRV treatment.
- Incidences of decreased appetite (11.0%) and weight decrease (6.7%) TEAEs were low.
Conclusions:
- Long-term adjunctive brivaracetam (BRV) is well-tolerated in growing children with epilepsy.
- BRV treatment did not demonstrate detrimental long-term effects on body weight or BMI.
- The findings support the use of BRV in pediatric epilepsy management with respect to weight parameters.
Objective:
The objective of this study is to evaluate possible long-term effects of treatment with brivaracetam (BRV) on body weight in children with epilepsy.
Method:
Post hoc analysis of data from patients (aged 1 month to <17 years) with ≥6 months of BRV treatment in a long-term, open-label trial (N01266 [NCT01364597]). Outcomes included body weight and body mass index (BMI) over time (z-score growth curves), and treatment-emergent adverse events (TEAEs). Previous/ongoing medical conditions that may affect body weight (gastrointestinal and metabolic/nutritional disorders); concomitant antiseizure medications (ASMs) were also evaluated.
Results:
Two hundred nine patients (mean [standard deviation] age 7.9 [4.6] years) were analyzed. Most (154 [73.7%]) had focal-onset seizures. At study initiation, median (range) BRV dose was 1.0 (0.4-7.5) mg/kg/day. Overall, 189 (90.4%) patients had a previous or ongoing medical condition (gastrointestinal disorders: 43 [20.6%]; metabolism/nutritional disorders: 26 [12.4%]). Most patients followed z-score curves for body weight and BMI during BRV treatment, although there were outliers in both directions. Incidences of appetite/weight-change TEAEs were low. Twenty-three (11.0%) patients had a TEAE of decreased appetite and 14 (6.7%) had a TEAE of weight decreased.
Significance:
Long-term adjunctive BRV was well tolerated in growing children with no indication of detrimental effects on body weight.
Plain Language Summary:
Brivaracetam is an antiseizure medication (ASM) used to treat seizures in people with epilepsy. Some ASMs can lead to changes in people's appetite and weight. Knowing the effect a drug has on appetite and weight is particularly important in children. We looked at 209 children with epilepsy taking brivaracetam and studied changes in their body weight and body mass index over time. The number of reported side effects related to appetite or weight change was low. There was no apparent long-term effect on their body weight, even when taking their medical history and use of other ASMs into account.
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