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

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. 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. 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). Brivaracetam was effective and well-tolerated in patients who required a change in AED drug regimen and initiated adjunctive brivaracetam in German clinical practice.

Informations de copyright

© 2020 UCB Pharma SRL. Epilepsia Open published by Wiley Periodicals LLC on behalf of International League Against Epilepsy.

Déclaration de conflit d'intérêts

This study was sponsored by UCB Pharma. The authors employed by UCB Pharma were involved in conduct of the research; in study design; in the collection, analysis, and interpretation of data; in writing the report; and in preparation of the article and the decision to submit the article for publication. Holger Lerche reports personal fees from Arvelle, Bial, BioMarin, Desitin, Eisai, and UCB Pharma and research support from Bial. Susanne Knake reports honoraria for speaking engagements from Desitin and UCB Pharma; educational grants from AD Tech, Desitin Arzneimittel, Eisai, GW, Medtronic, Novartis, Siemens, and UCB Pharma; and grants from the German Health Ministry and the State of Hessen outside the submitted work. Felix Rosenow reports personal fees from Cerbomed, Eisai, and GW Pharmaceuticals; Medtronic; and Shire; personal fees and other from Novartis; personal fees and grants from Desitin Arzneimittel and UCB Pharma; and grants from the European Union, the State of Hessen, Deutsche Forschungsgemeinschaft, and the Detlev‐Wrobel‐Fonds for Epilepsy Research Frankfurt outside the submitted work. Andreas Schulze‐Bonhage reports research support from Bial and Precisis; personal honoraria for lectures or advice from Bial, Eisai, Precisis, and UCB Pharma; and grant support from BMBF, DFG, Epilepsy Foundation, European Union, and NIH. Scarlett Hellot is contracted by UCB Pharma for statistical services. Iryna Leunikava and Anne‐Liv Schulz are employees of UCB Pharma. Peter Hopp reports personal fees from Bial, Eisai, and UCB Pharma. We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.