An FDA-approved antiseizure drug (ASM), brivaracetam (Briviact; UCB), had similar effects on the physical and mental health of people with epilepsy, regardless of whether they had an intellectual disability (ID). This was found in a study that was just released. Based on the available data and other studies, it seems that brivaracetam could be a suitable treatment option for patients with ID.
We analyzed data from 12 UK NHS Trusts between 2016-2022, including 102 patients with epilepsy but without intellectual disabilities, as well as 37 patients with both conditions. Out of the individuals with ID, 17 had mild levels, while 20 had moderate to profound levels. Individuals with ID had a higher likelihood of being younger (P <.001), male (P <.005), and having pre-existing neurodevelopmental conditions (P <.001). For the 12-month study, it was observed that the group without identification had slightly higher mean starting doses of brivaracetam compared to the other group (57 mg vs. 49 mg).
This ground-breaking study by Rohit Shankar, MBBS, FRCPsych, a professor of neuropsychiatry at the University of Plymouth, examined the effects of brivaracetam on patients with various degrees of intellectual disability and compared them to non-ID patients. After a year, brivaracetam was 30.2% more effective across all groups when it came to reducing seizures by 50% or more. In terms of efficacy rates, patients with ID (32.4%) showed similar results to the no ID group (29.4%), with no significant difference observed (P = .260). Among all the participants, individuals between the ages of 40 and 50, as well as those who were 50 years old or older, experienced significantly better efficacy outcomes compared to those who were under 30 years old (P = .02 and P = .05, respectively), even after considering the severity of their ID.
During the 12-month study, a significant number of patients, 25.5% in total, decided to discontinue brivaracetam. Interestingly, there were slightly higher withdrawal rates in both ID severity groups, with mild ID at 76.5% and mod-profound ID at 80.0%. However, it is important to note that these differences were not statistically significant (P = .660). The comparison of retention at 12 months between patients with ID (78.4%) and those without ID (73.0%) did not show a significant difference (P = .373).
Over the course of a year of treatment, a significant number of participants experienced physical and mental/behavioral adverse events (AEs), with 16.5% reporting physical AEs and 20.1% reporting mental/behavioral AEs. In the analysis, it was found that there were no differences in physical adverse events based on age, gender, and ID group (P = .869). There was a slightly higher prevalence of mental and behavioral adverse events in the group with intellectual disabilities compared to those without (27.0% vs 17.6%), but this difference was not statistically significant (P = .441).
There were certain limitations to the study, such as the fact that a significant number of NHS patients who were approached to participate did not, which means that the data might not accurately represent all patients who were prescribed brivaracetam at the study sites. Furthermore, the recruitment process took place from 2020 to 2022, resulting in the use of postal invitations to approach patients with ID instead of conducting face-to-face meetings in clinics, as was done in other Ep-ID arms. In addition, it is important for readers to exercise caution when interpreting these data, as the study had a small sample size and a higher risk of being underpowered.
In 2018, a groundbreaking study on brivaracetam was conducted in Spain. This study involved 570 patients, with 182 of them having ID. After a year of treatment, the retention rates stood at 70.4%. However, it was observed that brivaracetam was not as effective for individuals with ID, as they experienced a 50% lower reduction in reported seizure activity compared to those without ID (32.3% for ID, 43.4% for no ID; P = .011). It is worth mentioning that the occurrence of AEs was lower in individuals with ID (32.4%) compared to those without (43.3%; P = .013). In their overall assessment, the study authors found that the drug proved to be both safe and effective, with no unforeseen adverse events reported within the span of one year.