First clinical post-approval, observational study to assess clinical safety and effectiveness of brivaracetam sustained-release formulation in real-life settings of India: BEAM study.

PURPOSE

Brivaracetam (BRV) sustained-release (SR) tablets have recently been approved to treat focal seizures in India. SR formulations enhance patient adherence and quality of life (QoL). We assessed safety and effectiveness of BRV-SR for epilepsy management in Indian real-life settings.

METHODS

A post-approval observational study involving 1989 patients receiving BRV-SR from 181 centres were analysed. Primary endpoints are efficacy variables derived from seizure-related changes, and secondary endpoints include responder rate (≥50% reduction in focal-onset seizures [FoS]/focal-to-bilateral tonic-clonic seizures [FBTCS] frequency), usage pattern data, clinician's global impression on efficacy index (CGI-EI) and safety variables.

RESULTS

Patients' mean age was 42.33±12.33 years, and 1441 (72.44%) were men. Psychiatric comorbidities included depression (21.97%), sleep disturbance (15.54%), and anxiety (9.60%). The predominant seizure types were FoS (71.44%) and FBTCS (28.56%). BRV-SR 100 mg once-daily was most prescribed dose (57.37%) at baseline and follow-up visits (51.94%). Median seizure frequency decreased from 2 at baseline to 1 at follow-up visit. At follow-up, 72.1% patients were responders, and 63.75% were seizure-free. BRV-SR showed "marked" to "moderate" improvement in 92.99% of patients according to CGI-EI. Subgroup-analysis revealed a positive correlation between BRV-SR use in patients with drug-resistant epilepsy, psychiatric co-morbidities, and behavioural adverse events (AEs) with past anti-seizure medications. AEs were rare, with none reported in 97.39% patients during study period.

CONCLUSION

The BEAM study findings provide first real-world evidence on effectiveness and safety of BRV-SR in Indian real-life settings. Furthermore, BRV-SR is a feasible option for focal epilepsy management with good retention rates and improved QoL.