Author: Rachael Hansford

Bial and Eisai have announced clinical practice data from the Euro-Esli study demonstrating clinical effectiveness of eslicarbazepine acetate, and that it is generally well tolerated as an adjunctive therapy in focal epilepsy patients with psychiatric comorbidities, including intellectual disability, compared with people with no psychiatric comorbidities.[1] The data, which add to the body of evidence on eslicarbazepine acetate as adjunctive therapy from Phase III studies,[2],[3],[4],[5] were published in Journal of the Neurological Sciences.[1]

Psychiatric comorbidities, including intellectual disability and depression, are common for adults who have epilepsy.[6],[7] Prevalence of psychiatric comorbidities may be twofold higher in adult patients with epilepsy compared to the general public, and up to a quarter of people diagnosed with epilepsy are estimated to have an intellectual disability.[6],[7] Psychiatric comorbidities can exacerbate the effects and increase the impact of epilepsy.[8] Furthermore, antiepileptic treatments can interfere with treatments for the psychiatric comorbidities, and thus adversely affect these psychiatric conditions. [9],[10] There are many considerations for treating this patient population, thereby complicating treatment choice.[10]

“The comorbidities of epilepsy represent a substantial burden for people with epilepsy. This data provides a significant insight into how eslicarbazepine acetate performs in a routine medical setting for these patients and the results are very encouraging, demonstrating eslicarbazepine acetate’s efficacy and tolerability as an adjunctive therapy in this sub-set of patients,”

Dr Colin Doherty, Consultant Neurologist, St James’s Hospital, Dublin, Ireland, and lead author of the Euro-Esli study.

This newly published data includes patient populations that are sometimes excluded from clinical trials, including those with psychiatric comorbidities, specific comorbidities of intellectual disability, or depression.[1],[11] Adverse events reported during this sub-cut of the Euro-Esli study are consistent with eslicarbazepine acetate’s safety profile established in Phase III studies.[1],[2],[3],[4],[5] Adverse events with eslicarbazepine acetate treatment were reported by 43.1% of people with psychiatric comorbidities (n=122/283) and 45.8% of people with intellectual disability (n=49/107). The most common adverse events were dizziness (11.4%; n=31/272), somnolence (8.8%; n=24/272) and fatigue (8.1%; n=22/272) for people with psychiatric comorbidities; and somnolence (10.1%; n=10/99), dizziness (7.1%; n=7/99) and fatigue (6.1%; n=6/99) for people with intellectual disability.[1]

Psychiatric comorbidities

• Treatment with eslicarbazepine acetate in people with psychiatric comorbidities showed a responder rate of 83.1% (n=128/154) (defined by ≥50% seizure frequency reduction from baseline) at 12 months, compared with 82.5% (n=326/395) of people without psychiatric comorbidities (p=0.871). Seizure freedom was achieved by 51.3% of people with psychiatric comorbidities (n=79/154) (defined as no seizures since at least the prior visit) at 12 months with eslicarbazepine acetate treatment, compared with 51.4% (n=203/395) of people in the no psychiatric comorbidities group (p=0.984).[1]
• Adverse events were reported by 43.1% of people with psychiatric comorbidities (n=122/283) compared to 30.5% of people without psychiatric comorbidities (n=261/855; p<0.001). Psychiatric adverse events were reported by 3.7% of people with psychiatric comorbidities (n=10/272) compared to 1.8% of people without psychiatric comorbidities (n=15/822; p=0.076). Discontinuation of treatment with eslicarbazepine acetate due to adverse events occurred in 17.2% of people with psychiatric comorbidities (n=45/262) compared with 11.6% of people without psychiatric comorbidities (n=94/811; p=0.019).[1]

Intellectual disability

• Treatment with eslicarbazepine acetate in people with intellectual disability showed a responder rate of 60.3% (n=35/58) at 12 months, compared with 76.6% (n=222/290) of people without intellectual disability (p=0.010). Seizure freedom was achieved by 22.4% of people with intellectual disability (n=13/58) at 12 months with eslicarbazepine acetate treatment, compared with 43.1% (n=125/290) of people without intellectual disability (p=0.003).[1]
• Adverse events were reported by 45.8% of people with intellectual disability (n=49/107) compared to 32.6% of people without intellectual disability (n=275/844; p=0.007). Cognitive adverse events were reported by 4.0% of people with intellectual disability (n=4/99) compared to 3.8% of people without intellectual disability (n=31/809; p=0.919). Discontinuation of treatment with eslicarbazepine acetate due to adverse events occurred in 22.4% of people with intellectual disability (n=22/98) compared with 14.8% of people without intellectual disability (n=117/789; p=0.050).[1]

Depression

• Treatment with eslicarbazepine acetate in people with depression showed a responder rate of 81.0% (n=51/63) at 12 months, compared with 82.9% (n=402/485) of people without depression (p=0.703). Seizure freedom was achieved by 46.0% (n=29/63) of people with depression at 12 months with eslicarbazepine acetate treatment, compared with 52.0% (n=252/485) of people without depression (p=0.376).[1],[12]
• Adverse events were reported by 42.6% of people with depression (n=60/141) compared to 32.4% of people without depression (n=322/993; p=0.017). Psychiatric adverse events were reported by 4.4% of people with depression (n=6/136) compared to 2.0% of people without depression (n=19/955; p=0.074). Discontinuation of treatment with eslicarbazepine acetate due to adverse events occurred in 18.5% of people with depression (n=24/130) compared with 12.1% of people without depression (n=114/939; p=0.044).[1]

The Euro-Esli study presents a clinical practice data set of eslicarbazepine acetate with 2,058 patients included.[13] The Euro-Esli study has a broad set of inclusion/exclusion criteria, allowing for the representation of people with conditions sometimes excluded from clinical trials.[13],[14] The Euro-Esli study includes a diverse patient population with challenging comorbidities, and provides robust evidence to support clinical practice and treatment decisions.[13],[14]

Eslicarbazepine acetate is approved in the European Union (EU) as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.[15] Eslicarbazepine acetate has also been approved in the EU as monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy in 2017.[15]

Elekta has announced that Elekta Unity, a transformative magnetic resonance radiation therapy (MR/RT) system that enables personalised precision radiation medicine, is in clinical use at The Christie NHS Foundation Trust. Elekta Unity combines two technologies: a state-of-the-art 1.5T MRI scanner and a best-in-class 7 MV linear accelerator, driven by breakthrough real-time adaptive radiotherapy software. It provides the ability to reshape the dose based on daily changes in shape, size and position of the tumour and surrounding healthy anatomy, as visualised with MRI, and then enables accurate dose delivery with real-time visualisation of the tumour.

“Tumours are mobile, and they can change in size, shape and location within the body as a result of treatment, disease progression or regression, and normal physiologic activity such as breathing and digestion,” said Professor Ananya Choudhury, Chair and Honorary Consultant in Clinical Oncology at the Christie NHS Trust Foundation. “Prior to Unity, we did not have the technology to assess these changes on a daily basis. Unity provides an exciting new capability to provide patients with the best and precise cancer care possible. As the most advanced approach to radiation therapy, Unity gives us the ability to adapt treatment in real time to optimise radiation delivery to the tumour while sparing nearby healthy tissue.”

“The Christie NHS Foundation Trust was a founding member of the global consortium that helped develop Unity. We are very enthusiastic about this new technology due to the ability to see what we treat in real time and the potential to improve our radiotherapy treatments,” said Professor Corinne Faivre-Finn, Honorary Consultant Clinical Oncologist and Professor of Thoracic Radiation Oncology at the Christie NHS Trust Foundation. “Not only will Unity allow more precise delivery of radiation in cancers typically treated with this important form of therapy, it will also open the door to using radiation therapy in hard-to-treat cancers. We are gratified to see our vision of next-generation radiation therapy realised and available now to the patients we serve.”

To learn more, visit elekta.com/Unity.

The Neurokinex Charitable Trust is now able to offer bursaries to children living with paralysis at its Neurokinex Kids centre in Gatwick thanks to receiving £20,000 in funding from The Peter Harrison Foundation Community Fund. The ‘small grants fund’ organisation supports local community and voluntary groups and this award is part of its ‘Special Needs and Care for Children and Young People’ programme.

The Neurokinex Kids Centre Sponsorship Fund will allow access to cutting-edge neurological rehabilitation for eligible children living with all forms of paralysis, including spinal cord injury, stroke, transverse myelitis and cerebral palsy.

Neurokinex is a leading, not-for-profit provider of activity-based rehabilitation. Established in 2013, it is the first and only International affiliate of the Christopher & Dana Reeve Foundation’s NeuroRecovery Network®. Neurokinex sets out to ‘redefine possibilities’ for people with paralysis: its programmes stimulate and load the entire nervous and musculoskeletal systems through carefully crafted, task-specific exercises with the assistance of skilled therapists.

The Neurokinex Kids centre for paediatric neurorecovery opened its doors in April 2018 at the Neurokinex Gatwick site.  Neurokinex paediatric beneficiaries take part in activities such as active standing, cycling, swinging, climbing and walking, tailored to their neurological impairment. This offers children a multitude of benefits including improvements in neurological function, muscle bulk and quality, cardiovascular health, strength and stamina, balance and trunk control, skin and bone health, range of motion and psychological wellbeing.

“Securing this funding from The Peter Harrison Foundation will be life-changing for some of our young beneficiaries,” Kate Thornton-Jones, Fundraising Director for Neurokinex. “A spinal cord injury at any age is devastating, but it’s particularly serious in the very young.  That said, children’s bodies are highly adaptable and if injured youngsters are able to access quality rehabilitation, we can work together to maximise their rehabilitation. We are very grateful to The Peter Harrison Foundation whose generosity in funding these bursaries will support more families and ensure their children can access our support.”

Please contact trustees@neurokinex.orgtrustees@neurokinex.org for information on how to apply.

www.neurokinex.org

Eisai and the UK Dementia Research Institute (UK DRI) have announced the launch of a joint collaboration to support the advancement in dementia research. This first-of-its-kind industry collaboration for the UK DRI aims to deliver innovative research that translates into improvements in diagnosis, treatment and prevention of all types of dementia.

There are approximately 850,000 people with dementia in the UK, with numbers set to rise to over one million by 2025.¹ As the ageing of the global population gathers pace, the number of dementia patients worldwide is expected to follow this trend, with the total number of people with dementia projected to reach 82 million in 2030 and 152 million in 2050.²

To combat this global issue, the UK DRI draws together world-leading expertise into a single national institute that conducts research into all aspects of dementia including Alzheimer’s disease, Parkinson’s disease, frontotemporal dementia, vascular dementia, and Huntington’s disease.

Eisai is delighted to initiate this joint programme with the UK Dementia Research Institute, bringing new ideas and cutting-edge science to the significant challenge of dementia. As the UK Dementia Research Institute’s first joint collaboration with industry, this programme will provide an environment in which post-doctoral researchers at the forefront of dementia research in the UK can demonstrate the potential of their research to develop treatments for dementia patients.”

Dr Andy Takle, Executive Director and Head, Eisai Hatfield Research Laboratories.

Researchers will benefit from both the UK DRI’s state-of-the-art research facilities and Eisai’s drug discovery and translational expertise, and will support the work of the UK DRI in striving to elucidate novel drug discovery targets and mechanisms, develop new dementia models, and accelerate the linkage of these research results to diagnostics, treatment and care.

This collaboration is a wonderful example of the UK DRI’s desire to work with industry for the greater good of dementia science and patient outcomes. We are grateful for the investment and partnership of Eisai, and indeed for the work of all the dedicated researchers trying to move to new frontiers in addressing dementia. We look forward to seeing more fresh thinking on dementia, and to welcoming our colleagues at Eisai to the UK DRI community of ideas and energy.

Dr Adrian Ivinson, UK DRI Director and COO

Eisai has been conducting research on neurodegenerative diseases in the UK since 1990. In 2012 the company began a research collaboration with University College London (UCL) which will run until 2023, and was established as part of the company’s ‘Open Innovation’ strategy to collaborate with leading researchers and translate new research findings into innovative treatments for patients with neurodegenerative diseases.

References:

1. The Alzheimer’s Society. Facts for the media. https://www.alzheimers.org.uk/about-us/news-and-media/facts-media. Last accessed May 2019.
2. Alzheimer’s Disease International. World Alzheimer Report 2018.  https://www.alz.co.uk/research/WorldAlzheimerReport2018.pdf. Last accessed May 2019.