The observed increase in QOLIE-31 scores for patients with refractory disease was driven by increases on the energy-fatigue domain.
Gregory L. Krauss, MD
Data from a recent study has shown that patients with refractory epilepsy treated with cenobamate (Xcopri; SK Life Science) with strong treatment responses had high Quality of Life in Epilepsy Inventory-31 (QOLIE-31) scores compared to those who did not have strong responses.1
Among study presenters was Gregory L. Krauss, MD, professor, neurology, Johns Hopkins University. Krauss and colleagues wrote that “most patients in adjunctive treatment trials for treatment-resistant focal onset epilepsy do not benefit with improved QOLIE-31 scores despite significant reductions in seizures. Previous studies, however, suggest this often may be due to limited numbers of patients with drug resistant epilepsy who benefit from marked seizure reduction with new treatments.”
Krauss and colleagues presented at the American Epilepsy Society (AES) Virtual Meeting, December 4–8, 2020. They enrolled 49 adults with focal-onset resistant epilepsy into long-term cenobamate safety treatment studies, 37 (76%) of which continued treatment for a median of 5.6 years (range, 3–8). These patients had a mean number of previously failed antiepileptic drugs (AEDs) of 8.7 (standard deviation [SD], 2.6). The patients were evaluated after 2 to 7 years of treatment. Patients filled out the QOLIE-31 survey and other surveys to evaluate changes in independence and epilepsy-linked disability at the end of the study.
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Responder rates of ≥75% were seen in 45% of patients, ≥90% in 29%, and seizure freedom in 16% of patients during their last 3 months of treatment. Doses of cenobamate ranged from 100 to 400 mg/day and higher responder rates were associated with increasing cenobamate doses (P <.001). The mean QOLIE-31 score was 68 (SD, 18; range, 32–96). The average QOLIE-31 score was 60 for patients with an <50% responder rate, 71 for ≥50% responders, 73 for ≥75% responders, 81 for ≥90% responders, and 85 for patients that achieved seizure freedom. The averages for ≥90% and 100% responders were significantly higher than those with <50% response rates (P <.01).
Patients with high treatment responses had high QOLIE-31 scores regardless of intellectual disability. The increase in QOLIE-31 scores in high treatment responders was driven by increased scores on the energy-fatigue domain, the authors noted.
“Similar to previous surgery series and studies of non-refractory patients with epilepsy, many patients with treatment resistant epilepsy had strong treatment responses to cenobamate and high QOLIE-31 scores when compared to non-treatment responders,” Krauss and colleagues concluded.
Additional data on cenobamate presented by William Rosenfeld, MD, neurologist, Comprehensive Epilepsy Care Center at AES 2020 suggested that reducing doses of concomitant AEDs led to fewer patients with focal seizures discontinuing cenobamate.2
Patients discontinued AEDs or cenobamate due to adverse events, but this meant that patients that remained on cenobamate were able to reduce concomitant AEDs. In these patients, 91 of the 401 (22.7%) concomitant baseline ASM doses were discontinued completely. Carbamazepine accounted for 28.6% of patients, oxycarbazepine for 25%, lacosamide for 21.5%, eslicarbazepine for 23.1%, clobazam for 22.6%, lamotrigine for 15.4%, and levetiracetam for 14.1%.
These patients were able to decrease concomitant AEDs while also achieving seizure freedom or high responder rates. When comparing total baseline seizure frequency to last 3-month visit, 85% had ≥50% reduction, 74% had ≥75% reduction, and 57.2% had 100% reduction in seizures.
For more coverage of AES 2020, click here.