Author: Rachael Hansford

Blood tests for diagnosing dementia a step closer for UK

Posted on April 4, 2024 by - Alzheimer's Disease, Dementia

Two research teams will carry out UK-wide trials to identify accurate and quick blood tests that can diagnose dementia, in a bid to improve the UK’s diagnosis rate.  

Research teams at University College London, and Dementias Platform UK based at the University of Oxford, will capitalise on recent breakthroughs in potential dementia blood tests, and generate the evidence needed for them to be validated for use in the NHS within the next 5 years.  

The teams make up the Blood Biomarker Challenge – a multi-million pound award given by Alzheimer’s Society, Alzheimer’s Research UK and the National Institute for Health and Care Research and Gates Ventures including £5m raised by players of People’s Postcode Lottery. The project aims to revolutionise dementia diagnosis.  

Both teams will recruit participants from sites spread across the country, to ensure their findings are applicable to the whole of the UK’s diverse population.  

Timely and accurate diagnosis of the diseases that cause dementia, such as Alzheimer’s disease, is crucial as it means people can access vital care and support and take part in medical research. This will be even more imperative if new treatments are approved for use in the NHS, as these work best for people in the earliest stage of their disease.  

Currently, people are usually diagnosed using memory tests and brain scans. These are less accurate than ‘gold standard’ tests like PET scans or lumbar punctures, which can confirm what type of dementia they have. However, only 2% of people can access these specialist tests.  

Blood tests for diagnosing dementia

In recent years, a number of different blood tests for diagnosing dementia have shown very promising results in research settings. But they have yet to be tested widely in clinical settings in the UK.  

The READ-OUT* team will be led by Dr Vanessa Raymont, Professor James Rowe and Dr Ivan Koychev with Dementias Platform UK researchers from the Universities of Oxford and Cambridge. They will test multiple existing and novel blood tests, looking at a range of types of dementia, including Alzheimer’s disease, vascular dementia, frontotemporal dementia, and dementia with Lewy bodies. The researchers will also look at whether the blood tests can help detect these diseases at various stages.  

Led by Professor Jonathan Schott and Dr Ashvini Keshavan at University College London, the ADAPT team** will focus on the most promising biomarker for Alzheimer’s disease, called p-tau217. This reflects levels of two hallmark proteins found inside the brain in Alzheimer’s disease – amyloid and tau. The researchers will carry out a clinical trial to see whether measuring p-tau217 in the blood increases the rate of diagnosis for Alzheimer’s disease both in people with early dementia, but also in those with mild, progressive problems with memory.  

These complementary research approaches will maximise the chances of providing the evidence needed to prove that blood tests are ready for use in the NHS. They will pave the way for them to be made available to all who might benefit within the next 5 years.  

With more than half of all local authority districts in England failing to meet the government’s target dementia diagnosis rate of 66.7%, and with new drugs on the horizon which appear to slow early Alzheimer’s disease, experts from both charities and the research teams agree that change is needed.  

Professor Jonathan Schott, Alzheimer’s Research UK Chief Medical Officer and Professor of Neurology, UCL Queen Square Institute of Neurology, said: “An early, accurate diagnosis of Alzheimer’s disease is already important, allowing people to access to appropriate care and medications. If, as we hope, new treatments that can slow down Alzheimer’s disease become available soon, then this will be vital. This would pave the way for fair and equitable access to new and potentially life-changing treatments to all who might benefit.”  

Dr Vanessa Raymont, Associate Director, Dementias Platform UK and Senior Clinical Researcher, University of Oxford, said: “Since I first stepped into a memory clinic 30 years ago there has thankfully been a shift in the way society thinks about dementia. There was previously a feeling that this was just another part of aging, but now we’re seeing that people want to know more about their condition and they want a diagnosis as it helps them access the support they need. Both my parents lived with dementia so I know firsthand the devastation this disease causes, and how a timely and accurate diagnosis can benefit people and their families.”  

Fiona Carragher, Director of Research and Influencing at Alzheimer’s Society, said: “Dementia is the UK’s biggest killer, yet a third of people living with dementia don’t have a diagnosis, which means they’re not able to access care and support. An early and accurate diagnosis is also going to be vital in the future for identifying people who are most likely to benefit from new treatments, which are now within reach.  

At the moment only 2% of people with dementia can access the specialised tests needed to demonstrate eligibility for new treatments, leading to unnecessary delays, worry and uncertainty. Blood tests are part of the answer to this problem – they’re quick, easy to administer and cheaper than current, more complex tests. I’ve spent decades working in research and the NHS and, after years of slow progress, it feels like we’re on the cusp of a new chapter on how we treat dementia in this country. 

Fiona Carragher, Director of Research and Influencing at Alzheimer’s Society

Dr Sheona Scales, Director of Research at Alzheimer’s Research UK, said: “We’ve seen the enormous potential that blood tests are showing for improving the diagnostic process for people and their loved ones in other disease areas. Now we need to see this same step-change in dementia, which is the greatest health challenge facing the UK.   “It’s fantastic that through collaborating with the leading experts in the dementia community, we can look to bring cutting-edge blood tests for diagnosing dementia within the NHS. And this will be key to widening access to groundbreaking new treatments that are on the horizon.”  

For more information about the Blood Biomarker Challenge and how to take part, please visit: www.dementiasplatform.uk

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* The READ-OUT team (REAl World Dementia OUTcomes) for the first 3 years will run a fact finding study that will take blood tests in around 20 Dementias Platform UK sites across the UK, involving 3000 people from diverse populations. In the final 2 years, they will run a clinical trial with 880 people to explore how having a blood test for dementia affects diagnosis and quality of life, patients and carers, impact on care and how the results should be communicated to patients.

**The ADAPT team (Alzheimer’s disease Diagnosis And Plasma pTau217) will establish a ptau217 assay for use in the NHS before conducting a clinical trial with 1100 participants. Half will receive their test results after 3 months and half after 12 months, in order to understand whether the test makes a difference to the care their receive, the cost of their care and their quality of life.

Position of stroke patient’s head before surgery may improve neurological function

Posted on February 26, 2024 by - Stroke

Research Highlights: from American Stroke Association International Stroke Conference, February 2024

  • Hospital beds for stroke patients are typically elevated at the head, however, a flat head position before surgical removal of a blood clot in the brain (thrombectomy) may lead to better outcomes.
  • Results from a multicentre trial in the U.S. found significant improvements in clinical stability and neurological function for patients with 0-degree head positioning compared to patients with head positioning at a 30-degree angle, suggesting that 0-degree positioning may be an appropriate change to the standard of care for stroke patients before thrombectomy.
  • Head positioning is considered a manoeuvre to maintain blood flow for patients awaiting surgical intervention, not a stroke treatment itself.

Positioning patients with large vessel ischaemic (clot-caused) stroke with their heads flat (0-degrees) before surgery to remove the blood clot resulted in significant improvements in neurological function, compared to patients whose heads were elevated (at a 30-degree angle), according to science presented on February 7th at the American Stroke Association’s International Stroke Conference 2024. The meeting was held in person in Phoenix, Arizona, February 7 – 9, 2024.

Large vessel occlusion is a type of ischaemic stroke involving blockage of a major artery in the brain. A surgical procedure called thrombectomy removes the blood clot to restore blood flow and reduce the risk of death or permanent injury to the brain including a potential loss of neurological function.

“Many thrombectomy patients have delays until the procedure can be started, whether due to slow internal hospital processes, multiple patients arriving at the same time or if the patient needs to be transferred to another hospital. Optimising blood flow to the brain while patients are waiting for surgery, is essential to minimise the risk of neurological deficits and ultimately disability.” 

Anne W. Alexandrov, Ph.D., Lead Study Research and Professor of Nursing and Neurology at the University of Tennessee Health Science Center in Memphis

Currently, hospital beds for stroke patients awaiting thrombectomy surgery are typically set with the head of the bed at a 30-degree angle, or a slight incline, Alexandrov said. However, pilot studies conducted by Alexandrov’s team have shown that when the head of the bed is flat at 0-degrees, thrombectomy patients benefit from increased gravitational blood flow through the narrowed/blocked artery and more open collateral arteries for the procedure. 

In this randomised clinical trial called Zero Degree Head Positioning in Acute Large Vessel Ischemic Stroke or ZODIAC, researchers used the National Institutes of Health Stroke Scale (NIHSS) — which assesses consciousness, vision, speech, motor strength and sensory loss —  to evaluate stroke patients with large vessel occlusion acute ischaemic stroke. They compared if patients’ conditions remained stable or worsened depending on whether they were set with 0-degree head positioning vs. 30-degree head positioning before thrombectomy surgery.

Stroke patients’ baseline NIHSS scores were measured at 0-degrees immediately after neuroimaging, then they were randomly positioned to head positioning at either 0-degrees or 30-degrees. Patients underwent repeat NIHSS scoring every 10 minutes until the thrombectomy was performed, with a final NIHSS score assessed immediately before they were positioned on the surgical table.

An interim analysis found that 0-degree head positioning before thrombectomy surgery resulted in greater stability and/or clinical improvement prior to surgery based on repeated NIHSS scores in stroke patients compared to patients with 30-degree head positioning.

The investigators also explored whether there would be differences in the NIHSS score at 24 hours following surgery and at 7 days or discharge (whichever came first), however, they didn’t expect to find a difference because thrombectomy itself dramatically improves patient outcomes. They were surprised to find that at both 24 hours after surgery and at 7 days after discharge, the 0-degree-head-position patients had less neurological deficits on the NIHSS compared to patients with head-positioning at a 30-degree incline before surgery.

“By three months following surgery, there was no difference in outcomes for patients in either group, however, it’s exciting to see that we were able to discharge patients from the hospital with less disability requiring rehabilitation,” Alexandrov said.

Due to the efficacy of 0-degree head positioning for stroke patients awaiting thrombectomy, the study’s Data and Safety Monitoring Board stopped enrollment in this trial on November 1, 2023.

“Our findings suggest that gravitational force can play an important role in improving blood flow temporarily while patients are waiting for surgery,” Alexandrov said. “Zero-degree head positioning is a safe and effective strategy to optimise blood flow to the brain until the thrombectomy can be performed, and it should be considered the standard of care for stroke patients prior to thrombectomy.”

Abstracts presented at the American Heart Association’s scientific meetings are not peer-reviewed, rather, they are curated by independent review panels and are considered based on the potential to add to the diversity of scientific issues and views discussed at the meeting. The findings are considered preliminary until published as a full manuscript in a peer-reviewed scientific journal.

Non-pharmacological migraine treatment

Posted on February 23, 2024 by - Headache

Theranica’s REN Wearable Becomes the First Ever Non-Pharmacological Migraine Treatment to Receive Commercial Coverage in the USA

Feb. 20, 2024: Theranica, a prescribed digital therapeutics company specialising in neuromodulation devices for migraine and other idiopathic pain conditions, announced the inclusion of its Nerivio Remote Electrical Neuromodulation (REN) wearable, for use in the acute and preventive treatment of migraine, under a commercial coverage policy of Highmark Inc (Highmark). This follows the successful completion of its Coverage with Evidence Development (CED) programme with Nerivio, launched in November 2022. The new commercial coverage policy marks a significant advancement in the accessibility of an effective, non-disruptive, and non-pharmacological migraine treatment.

Professor Christopher Gottschalk, MD, FAHS, Neurology Division Chief and Director of the Headache & Facial Pain Center at Yale University and the President of the Alliance for Headache Disorders Advocacy (AHDA), welcomed this coverage policy: “Americans with chronic conditions like migraine have faced a longstanding need for insurance coverage of neuromodulation devices and other non-pharmacological treatments. Nerivio is an evidence-based treatment that is supported by well-controlled trials, and this coverage policy is an encouraging milestone. We at the AHDA have high hopes that other US commercial insurers and Federally funded insurance plans will follow the very sensible footsteps of Highmark and recognise the importance of providing the 40 million Americans living with migraine with affordable access to drug-free prescription migraine treatments with clinical benefits properly backed by high-quality data.”

Highmark’s coverage decision for the Nerivio REN wearable follows a rigorous CED study with the device, assessing its clinical benefits over 384 members living with migraine. In the primary endpoint of the study, Nerivio demonstrated statistically significant results in the reduction in Migraine Disability Assessment Score (MIDAS) from 64.0 to 43.9 points (p<0.005). Additional clinically meaningful benefits were demonstrated with 75.8% of the participants experiencing pain relief within 2 hours post-treatment, 37.3% reporting pain freedom, 69.0% indicating functional disability relief, and 52.4% specifying full return to functional ability post 2 hours.

The CED study shows statistically significant and clinically meaningful benefits to migraine patients treated with the REN wearable in a real-world environment. This data highlights the importance of including REN among migraine therapies covered by insurance to address the unmet need for effective, safe, easy-to-use migraine intervention.”

Andrea Synowiec, DO, FAAN, Vice Chair of the Department of Neurology at Allegheny Health Network in Pennsylvania, Primary Investigator

Is Long COVID a brain injury?

Posted on February 19, 2024 by - COVID-19 Articles

Study led by Benedict Michael finds global cognitive deficits

A recent study on Preprint server Research Square suggests that brain fog, memory and concentration problems may be due to brain injury caused by the COVID-19 virus.

The study found that 351 patients hospitalised with severe COVID-19 had evidence of a long-term brain injury a year after contracting the SARS-CoV-2 virus – this was compared against 2,927 healthy controls. These findings were based on cognitive tests, self-reported symptoms, brain scans, and biomarkers. 

More than 60% of COVID-19 survivors display persistent symptoms even months or years following recovery from the primary infection, significantly impacting their quality of life.

Treatment with corticosteroids during the acute phase appeared protective against cognitive deficits. The study authors suggest that “These findings support the hypothesis that brain injury in moderate to severe COVID-19 is immune-mediated, and should guide the development of therapeutic strategies.”

Potential treatments for secondary brain cancer

Posted on February 7, 2024 by - Brain tumours

Drugs already licensed could be trialled to potentially treat secondary brain cancer, new research finds

The largest review of papers for brain cancer that has spread from the lungs has found abnormalities in the brain cancer. Licensed drugs could be clinically trialled to find out if they could treat the disease. The research led by the University of Bristol and published in Neuro-Oncology Advances also found genetic differences between smokers and non-smokers.

Around 25,000 patients in the UK suffer from cancer that has spread to the brain – known as metastases – most commonly from lung and breast cancer, and which causes death in the majority of these patients.

The genetic mutations in primary lung cancers have been widely studied, but less is known about the changes in the cancer once it has spread to the brain. The research team wanted to find out the genetic changes in brain metastasis from non-small cell lung cancer (NSCLC) and whether there are drugs already available that could potentially be offered to these patients.

The researchers carried out a review from 72 papers of genetic mutations in brain metastasis of NSCLC from 2,346 patients’ data on patient demographics, smoking status, genomic data, matched primary NSCLC, and PD-L1, which is a protein found on cancer cells.

The study found the most commonly mutated genes were EGFR, TP53, KRAS, CDKN2A, and STK11.  Common missense mutations —mutations that lead to a single amino acid change in the protein coded by the gene— included EGFR L858R and KRAS G12C

In certain cases the genetic mutations were different in the brain metastasis from the primary lung cancer. There were also differences in the genetic mutations in smokers versus patients who had never smoked. Brain metastases of smokers versus non-smokers had different missense mutations in some mutated genes.

The research team found from the top ten commonly mutated genes which had primary NSCLC data, 37% of the specific mutations assessed were different between primary NSCLC and brain metastases. The researchers suggest Medicines and Healthcare products Regulatory Agency-approved drugs already licensed could potentially be tested to treat the disease in clinical trials.

Kathreena Kurian, Professor of Neuropathology and Honorary Consultant at North Bristol NHS Trust, Head of the Brain Tumour Research Centre at the University of Bristol and co-author of the paper, said: “Our research recommends that all patients should have their brain metastasis examined for mutations in addition to their primary lung cancer because they may be different.

“This evidence could form the backbone for new clinical trials for patients with brain metastasis in non-small cell lung cancer using drugs that are already available.”

Our research recommends that all patients should have their brain metastasis examined for mutations in addition to their primary lung cancer because they may be different. This evidence could form the backbone for new clinical trials for patients with brain metastasis in non-small cell lung cancer using drugs that are already available.

Kathreena Kurian

The research was funded by Cancer Research UK; Southmead Hospital Charity: Brain Tumour Bank Research (fund 8036); Innovate UK; and the National Institute for Health and Care Research (NIHR). 

Kathreena Kurian is Chair of the Bristol Cancer Research Network, which is supported by Elizabeth Blackwell Institute.

Paper

‘Genomic landscape and actionable mutations of brain metastases derived from non-small cell lung cancer: a systematic review‘ by Lily J Andrews, Kathreena M Kurian et al. in Neuro-Oncology Advances [open access]

Immune response responsible for neurological damage

Posted on February 6, 2024 by - Neuroimmunology

There has been a long-held belief that acute viral infections are directly responsible for neurological damage, but researchers from McMaster University have now discovered that it is the immune system’s response that is behind it.

The research, published on February 5, 2024 in Nature Communications, was led by Elizabeth Balint, a PhD student at McMaster, and Ali Ashkar, a Professor with the Department of Medicine and the Canada Research Chair in Natural Immunity and NK Cell Function.

“We were interested in trying to understand why so many viral infections are associated with neurological diseases,” says Balint. “Our evidence suggests that it’s not the virus itself that causes the damage, but a unique population of T cells, which are part of the immune system, that are actually responsible for the damage.”

Our evidence suggests that it’s not the virus itself that causes the damage, but a unique population of T cells, which are part of the immune system, that are actually responsible for the damage.

Elizabeth Balint, a PhD student at McMaster University

To come to this conclusion, the McMaster team focused on Zika virus. During laboratory testing, researchers, as expected, found T cells that were specific for Zika and designed to eliminate infected cells. They found something else, too.

“What was interesting in our study is that although we did find some T cells specific for Zika, we identified cells that weren’t functioning like a normal T cell and were killing lots of cells that weren’t infected with Zika.”

These cells are called NKG2D+CD8+ T cells and researchers say their aggressive response is responsible for neurological damage suffered from infections beyond just Zika, like COVID-19 and even septic shock.

The aggressive response is the result of the body producing large amounts of inflammatory proteins called cytokines, which in moderation help to coordinate the body’s response in battling an infection or injury by telling immune cells where to go and what to do when they arrive.

“If our body’s immune cells overreact and over produce inflammatory cytokines, this condition will lead to non-specific activation of our immune cells which in turn leads to collateral damage. This can have severe consequences if it happens in the brain,” Ashkar says.

The discovery offers researchers and scientists a new target for treatments of neurological diseases sparked by acute viral infections. In fact, Balint has already found a treatment that holds promise.

“Elizabeth has experimented with an antibody that can completely block and treat devastating neurotoxicity in the animal model, which is already in clinical trials  for different uses in humans,” says Ashkar.

Balint hopes to continue her work towards finding a treatment that would be effective in humans.

“There are a few different other viruses we’re interested in studying, which will aid us in creating the best treatment options,” Balint says.

Funding for this study was provided by the Canadian Institutes of Health Research. Balint is also a recipient of a Canada Graduate Scholarship Doctoral Award.

Biogen drops Alzheimer’s drug Aduhelm

Posted on February 1, 2024 by - Alzheimer's Disease

31 January 2024; Biogen has announced that it will discontinue the development and commercialisation of ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use and will terminate the ENVISION clinical study. This decision is not related to any safety or efficacy concerns. A large portion of the resources released resulting from termination of the ADUHELM programme will be redeployed in Biogen’s AD franchise.

We plan to further advance the launch of LEQEMBI, together with Eisai, and continue to bolster innovation with the development of the other assets in our pipeline. When searching for new medicines, one breakthrough can be the foundation that triggers future medicines to be developed. ADUHELM was that groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the field.”

Christopher A. Viehbacher, President and Chief Executive Officer of Biogen

In January 2023, Biogen began a strategic review of its research and development efforts, including seeking potential partners or external financing for ADUHELM, as part of a focus on prioritising the company’s portfolio. During this process, Biogen considered the time and investment required for the post-marketing confirmatory ENVISION study and the likely advancements in the field by the time of potential ADUHELM FDA traditional approval. Despite an extensive process, the company did not identify potential strategic partners or external financing.

“We have gained significant insight from the development of ADUHELM and will carry this forward as we continue our pioneering work in Alzheimer’s disease,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “We’d like to sincerely thank the trial investigators, healthcare providers, advocates, patients and families involved in the development of ADUHELM. We are grateful to Neurimmune for its scientific contributions and collaboration over many years.”

ADUHELM received accelerated approval from the U.S. Food and Drug Administration in June 2021. The Phase 4 post-marketing confirmatory ENVISION study was a requirement of FDA accelerated approval of ADUHELM.

Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen commercialising and co-promoting the product and Eisai having final decision-making authority.

Emylif – orodispersible film for ALS

Posted on January 24, 2024 by - Amyotrophic Lateral Sclerosis (ALS)

  • Orodispersible film formulation of disease-modifying drug riluzole now available to ALS patients in the UK
  • Emylif offers an alternative for the 80% of patients who experience difficulty swallowing during the course of their disease1

January 24, 2024: In November 2023, Zambon UK launched Emylif, a new formulation of riluzole in an orodispersible film – for the treatment of adults with amyotrophic lateral sclerosis (ALS).  Emylif offers an alternative to the tablet administration of riluzole which can be difficult for patients to take as their disease progresses and they develop dysphagia (difficulty swallowing). Dysphagia occurs in around 80% of ALS patients over the course of their disease1.

Emylif is applied to the tongue and allowed to dissolve, with no need for water, tongue mobility or muscular strength. Studies have demonstrated that this mode of administration is bioequivalent to the tablet form of riluzole.2

Riluzole is the only disease-modifying treatment available to ALS patients in the UK. Currently, it is common practice for carers to crush riluzole tablets in order to administer them to patients who are finding it difficult to swallow tablets.3 Emylif offers a licenced alternative for these patients.

The safety profile of Emylif is very similar to that of other riluzole formulations, with the exception of oral hypoesthesia (numbness in the mouth). It is common for patients to experience mild and transient oral hypoesthesia which can last for an average of around 40 minutes.5 In a small-scale study in ALS patients there was no detrimental effect on swallowing following a single dose of riluzole orodispersible film.6 It is suggested that patients are counselled on the risk of numbness in the mouth so that they are not surprised or concerned if this occurs. 

References

  1. Muscaritoli M, Kushta I, Molfino A, Inghilleri M, Sabatelli M, Rossi Fanelli F. Nutritional and metabolic support in patients with amyotrophic lateral sclerosis. Nutrition (2012) 28(10):959-66. doi:10.1016/j.nut.2012.01.011
  2. Di Stefano AFD, Radicioni MM, Segantin A, Gentili A, Baroglio C, Marjanović I, Cattaneo C (2022) Randomised, 2-Sequence, 4-Period Replicate Cross-Over Bioequivalence Study of a New Riluzole Orodispersible Film Vs. A Reference Tablet in Healthy Volunteers. J Bioeq Stud 8(1): 101
  3. Dyer AM, Smith A. Riluzole 5 mg/mL oral suspension: for optimized drug delivery in amyotrophic lateral sclerosis. Drug Des Devel Ther. 2017;11:59-64. https://doi.org/10.2147/DDDT.S123776
  4. Thong MY, Manrique YJ, Steadman KJ. Drug loss while crushing tablets: Comparison of 24 tablet crushing devices. PLoS One. 2018 Mar 1;13(3):e0193683. doi:10.1371/journal.pone.0193683. PMID:29494695; PMCID: PMC5832315
  5. Emylif Summary of Product Characteristics
  6. Wymer J, Apple S, Harrison A, Hill BA. Pharmacokinetics, Bioavailability, and Swallowing Safety With Riluzole Oral Film. Clin Pharmacol Drug Dev 2023 Jan;12(1):57-64.doi:10.1002/cpdd.1168

Treating spasticity with injection guidance techniques

Posted on January 23, 2024 by - Industry News, Rehabilitation

AboLiSh study demonstrates clinical benefit of injection guidance when treating spasticity with abobotulinumtoxinA

  • AboLiSh is the first global study to demonstrate the clinical benefit of using injection guidance techniques to improve patient goal attainment
  • Analyses of study data indicated that patients who are administered treatment with Dysport® (abobotulinumtoxinA) with the use of injection guidance techniques are nearly 3 times more likely overall to achieve their goals
  • The study highlights that almost 1 in 4 clinicians are not using injection guidance when administering abobotulinumtoxinA

19th January, 2024: Ipsen has announced top line results from its real-world AboLiSh study (NCT04050527), presented at the 7th international TOXINS conference in Berlin, Germany. The study evaluated utilisation and effectiveness of Dysport® (abobotulinumtoxinA) in people living with lower-limb spasticity and found that injection guidance techniques significantly help to improve outcomes and goal attainment in patients.

AboLiSh was a prospective 16-month observational study with a primary endpoint of goal attainment measured by subject centred Goal Attainment Scaling-Leg (LegA) T score. Topline results demonstrated statistically significant improvement in rehabilitation goal attainment in instances where physicians used guidance techniques, such as ultrasound, electrostimulation, electromyography or a combination of techniques, to deliver the first cycle of treatment to patients, compared to those receiving treatment without the use of guidance techniques. Patients who received abobotulinumtoxinA (AboBoNT) injections with the support of injection guidance were nearly 3 times (2.7) more likely overall to achieve their rehabilitation goals.

The AboLiSh study, which assessed 430 patients in 9 countries in Europe, the Americas, Australia and Russia, found that while the majority of clinicians already use guidance techniques, almost 1 in 4 clinicians (23%) administered AboBoNT without guidance, which was associated with reduced goal attainment and could lead to negative consequences, including patient adherence to neurotoxin injections.

“These findings highlight a current lack of consistency in how treatment is being administered to patients and underpin the importance of real-world evidence to inform clinical practice”, said Dr Alberto Esquenazi MD, Director Gait & Motion Analysis Laboratory at Jefferson Moss-Magee Rehabilitation in Philadelphia. “It is crucial that we consistently and routinely use our clinical assessment skills and the injection guidance tools available to us to ensure patients achieve their goals and their treatment is optimised.”

Patients who received abobotulinumtoxinA (AboBoNT) injections with the support of injection guidance were nearly 3 times (2.7) more likely overall to achieve their rehabilitation goals.

Ipsen is committed to further improving patient care for people living with spasticity and the study findings will be used to support Ipsen’s ongoing work to support the training of clinicians on the use of neurotoxin injections for the treatment of spasticity.

“We want to do our part to ensure those receiving treatment with Dysport have access to the best standards of care and are given every opportunity to achieve their goals.” says Sandra Silvestri, Chief Medical Officer, Ipsen. “To help facilitate this we are greatly expanding our Ixcellence program for neurology and rehabilitation specialists in 2024 which will utilise our global network of expert trainers to provide advanced education and knowledge transfer across a broad range of techniques essential to improving outcomes in patients with post stroke spasticity, including anatomy, ultrasound and goal setting.”

Clinicians taking part in the study were not given a protocol for the use of guidance techniques allowing them to treat patients in accordance with their standard practice. Results were determined using a cumulated (mean) Goal Attainment Scaling-Leg (LegA) T score, measuring the difficulty in passive and active muscle function following therapeutic intervention, across treatment cycles for each individual patient. No new safety signals were identified during the trial.