Brivaracetam substituting other antiepileptic treatments: Results of a retrospective study in German epilepsy centers

Holger Lerche; Susanne Knake; Felix Rosenow; Andreas Schulze-Bonhage; Scarlett Hellot; Iryna Leunikava; Anne-Liv Schulz; Peter Hopp

doi:10.1002/epi4.12415

Brivaracetam substituting other antiepileptic treatments: Results of a retrospective study in German epilepsy centers

Epilepsia Open. 2020 Jul 22;5(3):451-460. doi: 10.1002/epi4.12415. eCollection 2020 Sep.

Authors

Holger Lerche¹, Susanne Knake², Felix Rosenow³, Andreas Schulze-Bonhage⁴, Scarlett Hellot⁵, Iryna Leunikava⁵, Anne-Liv Schulz⁵, Peter Hopp⁶

Affiliations

¹ Department of Neurology and Epileptology Hertie Institute for Clinical Brain Research University of Tuebingen Tuebingen Germany.
² Department of Neurology Epilepsy Center Hessen Philipps-University Marburg Marburg Germany.
³ Epilepsy Center Frankfurt Rhine-Main Neurocenter University Hospital Frankfurt and Center for Personalized Translational Epilepsy Research (CePTER) Goethe-University Frankfurt am Main Germany.
⁴ Epilepsy Center University Medical Center Freiburg Freiburg Germany.
⁵ UCB Pharma Monheim am Rhein Germany.
⁶ Epilepsy Center Kleinwachau Radeberg Germany.

Abstract

Objective: To evaluate the success of initiation of adjunctive brivaracetam in patients who required a change in antiepileptic drug (AED) regimen and substituted at least one AED with brivaracetam.

Methods: In this retrospective noninterventional study conducted in specialized epilepsy centers across Germany, patients initiated adjunctive brivaracetam between February 15, 2016, and August 31, 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 or within 6 months after brivaracetam initiation.

Results: Five hundred and six patients had at least one brivaracetam dose and were included in the safety set (SS). Four hundred and seventy 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. At baseline, patients had a median of seven lifetime AEDs and a median of 3.8 seizures/28 days. In the SS, 85.2% of patients withdrew one AED before/after initiation of brivaracetam, most commonly levetiracetam (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 (3-month baseline) 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 adjunctive brivaracetam in German clinical practice.

Keywords: antiseizure; behavioral adverse events; drug‐resistant epilepsy; focal seizures; noninterventional.