Summary, published in Epilepsy Open
Objective: To evaluate the success of initiation of “add-on” brivaracetam in patients who required a change in antiepileptic drug (AED) regimen and substituted at least one AED with brivaracetam.
Methods: In this retrospective non-interventional study conducted in specialized epilepsy centers across Germany, patients initiated “add-on” brivaracetam between 15 February and 31 August 2016, as part of an intended change in AED regimen. The primary effectiveness variable was the proportion of patients who continued on brivaracetam after 3 months and withdrew at least one AED either before/within 6 months after brivaracetam initiation.
Results: 506 patients had at least one brivaracetam dose and were included in the safety set (SS). 470 patients started to reduce the dose of one AED before/after brivaracetam initiation, had at least one concomitant AED at brivaracetam initiation and were included in the full analysis set (FAS) for effectiveness analyses. In the SS, 85.2% of patients withdrew one AED before/after initiation of brivaracetam, most commonly levetiracetam (Keppra® [(49.4%)]. 46.2% of patients substituted another AED with brivaracetam within 24 hours (fast withdrawal). The proportions of patients (FAS) who continued on brivaracetam after 3 and 6 months and withdrew one AED were 75.5% and 46.6%, respectively. After 6 months, 32.1% of patients were 50% responders; 13.0% were seizure-free. In the SS, 34.6% of patients reported treatment-emergent adverse events (TEAEs); 21.9% had TEAEs that were assessed by the treating physician as drug-related. Incidences of behavioral AEs before and after brivaracetam initiation in patients who withdrew levetiracetam were 19.2% and 8.0%, respectively (5.0% and 7.7% in patients who withdrew other AEDs).
Significance: Brivaracetam was effective and well-tolerated in patients who required a change in AED drug regimen and initiated “add-on” brivaracetam in German clinical practice.