Fintepla improves life quality for affected families in European study

Caregivers report fewer seizures in children treated with Fintepla

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

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Caregivers of children with Dravet syndrome report that their child’s use of Fintepla (fenfluramine) significantly reduces seizure burden and leads to a number of quality-of-life benefits for their children, themselves, and the rest of their family.

That’s according to a recent study conducted in Europe, which involved interviews with parent caregivers as well as their children’s clinicians, who generally corroborated caregiver reports.

Overall, the findings “replicate and extend previous research findings regarding the perceived benefits of [Fintepla] on the [quality of life] of individuals with DS [Dravet syndrome], their caregivers, and their families,” researchers wrote. “Longitudinal research is needed to understand the time course and magnitude of these improvements.”

The study, “Fenfluramine treatment for Dravet syndrome: Caregiver- and clinician-reported benefits on the quality of life of patients, caregivers, and families living in Germany, Spain, Italy, and the United Kingdom,” was published in Epilepsy Research.

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Fintepla approved in US, Europe, and Japan for Dravet

Fintepla, an oral solution of low-dose fenfluramine developed by Zogenix, now part of UCB, is approved in the U.S., Europe, and Japan to treat seizures in Dravet patients, 2 years and older.

Fenfluramine was originally developed as an appetite suppressant, and primarily works by increasing levels of serotonin, an important brain signaling chemical.

Evidence suggests that, in addition to seizure control, Fintepla has other benefits, including improvements in several quality-of-life domains reported by caregivers.

Researchers at Zogenix and the University of Washington previously conducted a study involving semi-structured interviews with 65 caregivers of Dravet patients on Fintepla in the U.S.

Surveyed parents reported improvements in their children’s cognitive function, alertness, and educational performance, as well as improvements in their own sleep quality, reductions in stress, and better family relationships.

The same research team set out to replicate and extend those findings by interviewing caregivers and doctors of Dravet patients who participated in the European Early Access Program that allowed access to Fintepla before marketing approval.

Those patients were treated in Spain, Germany, the U.K., and Italy.

Overall, one of the biggest improvements on [Fintepla] is increased attention of patients.

Study included 25 caregivers of children treated with Fintepla for about 2 years

A total of 25 caregivers (64% women, mean age of 47 years) were recruited. At the time of the interviews, their children were a mean age of 12 (range of 3 to 24 years) and had been using Fintepla for a mean of 22 months, or nearly two years.

The 16 clinicians (38% women) included in the study were either epilepsy experts (94%) or neurologists (6%), and had a mean of 19 years of practice experience.

Results showed that benefits in all evaluated seizure-related parameters were reported as occurring frequently by both caregivers and clinicians.

All clinicians and 92% of caregivers reported reductions in seizure frequency, while there were no reports of seizures getting worse. Other seizure-related benefits reported by at least half of caregivers and clinicians included reductions in frequency or type of seizure triggers (63%-64% of respondents), and a shorter post-seizure recovery time (50%-52%).

Also, more than two-thirds of both groups reported improvements in cognitive function (84%-100%), focus (76%-94%), alertness (72%-100%), and speech (70%-75%). Gains in academic performance, behavior, sleep quality, problem-solving, and motor function were reported by more than half of both caregivers and clinicians.

Notably, improvements in cognitive function and executive function — reflected by better focus, alertness, speech, academic performance, and problem-solving — were the most common non-seizure benefits reported in this and the previous U.S. study, the team noted.

“Overall, one of the biggest improvements on [Fintepla] is increased attention of patients. Reduced need for support in school,” one clinician said.

It’s possible that other gains are secondary to cognitive improvements, the team noted, adding that “research that would test the role of cognitive function in determining overall [quality of life] in individuals with DS is warranted.”

Caregivers also reported gains in several areas of their own lives, including improved sleep quality (72%) and mood (68%), as well as fewer feelings of being overwhelmed (64%) and incidences of missed work (63%), and less stress (60%).

They also reported improvements in their relationship with a partner (52%) and feeling that they had more time to do things they enjoy (52%).

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92% of caregivers report general improvement in children’s condition

Changes in family-related outcomes, including decreased family stress, better relationships between patients and their siblings, and the family participating in activities with others, were also reported for at least half of the families.

These improvements were generally corroborated by clinicians, but some discrepancies “could be due to clinicians’ limited ability to observe benefits to caregivers and siblings,” the researchers wrote.

“Also, the study was conducted during the COVID-19 pandemic, and siblings or both spouses were often not allowed to attend clinical visits,” they added.

Overall, 92% of caregivers reported a general improvement in their child’s condition since starting Fintepla. Moreover, 96% of caregivers and all clinicians said they were very or quite likely to recommend the treatment to other families living with Dravet.

The findings “generally replicate those from the sample of caregivers who live in the USA, especially with respect to seizure related outcomes,” the team wrote, and they have “important implications for conclusions regarding the reliability of the beneficial effects of [Fintepla].”