Author: Rachael Hansford

A prodrome for MS?

Posted on December 5, 2023 by - Multiple Sclerosis

Study in Neurology evaluated the associations between diseases and symptoms diagnosed in primary care

The researchers show that, on a population scale, the frequency of disorders such as depression, constipation, and urinary tract infections is associated with a diagnosis of multiple sclerosis five years later. These results outline a prodromal phase of the disease.

Several studies have already suggested that, in some patients, subtle symptoms were present up to ten years before a diagnosis of MS. What remained was to quantify this phenomenon at the population scale to rigorously define a ‘prodromal phase’, i.e. a period during which the disease takes hold discreetly. A better understanding of early symptoms of MS could help researchers pinpoint the exact moment when the inflammatory process that causes lesions in the central nervous system begins.

“One of the major difficulties with multiple sclerosis is that we do not observe a strict correspondence between the severity of lesions on nerve fibres and patients’ symptoms. This considerably limits our ability to predict the course of the disease,” said Professor Céline Louapre, a Neurologist at Pitié-Salpêtrière Hospital and Head of Paris Brain Institute’s clinical investigation center.

“The challenge today is to detect the disease as early as possible, well before the lesions are visible on MRI, in the hope of delaying the onset of disability. Of course, not everyone who has these symptoms will go on to develop MS.’ She added that all four are ‘common’ and ‘could also be signs of other diseases’.

Professor Louapre, accompanied by Octave Guinebretière and Thomas Nedelac, compared the health data of 20,174 patients with multiple sclerosis, 54,790 patients without multiple sclerosis, and 37,814 patients affected by two autoimmune diseases which, like MS, mainly affect women and young adults—namely 30,477 patients with Crohn’s disease and 7,337 with lupus.

The researchers observed that five symptoms were significantly associated with a later diagnosis of multiple sclerosis: depression, sexual disorders, constipation, cystitis, and other urinary tract infections.

“This association was sufficiently robust at the statistical level for us to state that these are early clinical warning signs, probably related to damage to the nervous system, in patients who will later be diagnosed with multiple sclerosis,” Professor Louapre explains. “The overrepresentation of these symptoms persisted and even increased over the five years after diagnosis.”

However, these five symptoms also appeared in the prodromal phase of lupus and Crohn’s disease, which means they are not specific to MS. Most importantly, they are also widespread in healthy people.

A prodrome for MS?

“These signs alone will not be enough to make an early diagnosis, but they will certainly help us better understand the mechanisms of multiple sclerosis—which has many causes—and reconstruct its natural history. Finally, these new data support the idea that the disease begins well before the onset of classic neurological symptoms,” concludes Professor Louapre.

Ubrelvy for migraine: positive phase III data

Posted on December 2, 2023 by - Headache

AbbVie recently announced its publication in The Lancet showing that administration of Ubrelvy (ubrogepant) during the prodrome stage of a migraine can reduce the likelihood of a migraine attack developing. Ubrelvy is the first and only acute migraine treatment that has demonstrated Phase III data in the prodrome stage.

Christie Wong, Pharma Analyst at GlobalData, comments: “The prodrome stage of a migraine occurs between one to six hours before the onset of a migraine attack, and the symptoms can include sensitivity to light and sound, fatigue, and neck stiffness and/or pain. However, not all migraine patients experience prodromal symptoms, and the migraine stages may vary in terms of duration and severity between patients. Thus, Ubrelvy could provide an additional benefit to a subset of migraine patients who are able to identify prodromal symptoms.”

There are many acute treatments for migraine pain relief, but some patients cannot tolerate triptans, which are the gold standard treatment. Ubrelvy could give patients who are able to identify prodromal symptoms the ability to treat migraine during the early stages.

Ubrelvy is the first and only acute migraine treatment that has demonstrated Phase III data in the prodrome stage.

Read headache articles in ACNR’s Headache Archives

Digital therapies for tic disorders 

Posted on December 1, 2023 by - Uncategorised

NICE are performing a technology assessment to look at digital enabled therapy for tic disorders in children and young people

NICE will assess digital therapies for tic disorders in children and young people to determine whether they can be recommended for use in the NHS, based on the available evidence and cost-saving potential. They are recruiting for a lay specialist committee and a medical technology advisory committee.

Tics are fast, repetitive muscle movements that result in difficult to control body movements or sounds. Some tics involve body movements (motor) or sounds (phonic). Examples of tics may include: blinking, grimacing, head jerking, head banging, finger clicking, coughing, grunting, sneezing, repeating a sound or phrase. Tics can lead to significant pain and discomfort and can cause distress. Young people may find that tic disorders can interfere with school and in their social lives. Around 70,000 children and young people in England have Tourette syndrome, the condition commonly associated with chronic tics. Tic disorders may be treated with provision of psychoeducation to children and their families, behavioural therapies (a branch of psychological therapies which may include Habit Reversal Training, Comprehensive Behavioural Intervention for Tics and Exposure and Response Prevention), or in some instances with medications.

There is a lack of trained specialists in the UK currently, resulting in only 20% of young people with tic disorders accessing behavioural therapy, and less than half of this group receiving the recommended number of sessions. Geographical inequality also means that face-to-face treatment is often not available, or people are on long waiting lists to then travel long distances for access. The use of new technologies could help ensure timely access to services such as, school mental health support teams, single point of access (SPA) teams, voluntary sector teams and children and young people’s mental health services (CYPMHS). It could also reduce inequalities by reducing variations in access to care.

Using digitally enabled therapy may reduce the need to take medication and reduce the associated adverse effects with these medicines. The NICE health technology assessment will evaluate innovative digitally enabled therapies for tics. It will review the evidence that is available and assess the potential clinical and cost-effectiveness of the technologies, as well as identifying evidence gaps to help direct data collection.

Email medtech@nice.org.uk for more information, or register as a stakeholder to give your views.

Watch Tourettes Action CEO Emma McNally discussing living with Tourettes on BBC Breakfast.

Organoid intelligence

Posted on November 14, 2023 by - Artificial Intelligence

A Swiss startup is creating computer processors using living neurons from human skin

Instead of relying on digital chip processors, a Swiss startup called FinalSpark believes the world needs biological ones that use much less energy. FinalSpark says that it has tested 10 million living neurons and that research work is already underway on building thinking machines from live human neurons derived from skin.

The company is growing neurons in cell cultures to showcase self-sustaining computing capability for the future creation of AI models. They want to lead the shift from artificial engineering to biological engineering, predicting that DNA data storage may outperform cloud storage in the future, in terms of sustainability and efficiency.

Current AI models copy human thinking after months of training on data. FinalSpark wants to achieve actual human reasoning capable of analysing emotions, while creating new ideas and concepts outside its own experience.

Organoid Intelligence

In February, scientists led by researchers at Johns Hopkins University in Baltimore detailed a plan for what they called “organoid intelligence.” This would work by designing a thinking system of tiny three-dimensional neural structures grown from human stem cells. These would be connected to sensors and output devices and trained through machine learning. “Looking at this trend, one can imagine that biological neural networks could also replace artificial neural networks for many computing applications, including AI,” said FinalSpark co-founder Fred Jordan.

Read more…

organoid intelligence

New treatment for myasthenia gravis

Posted on November 10, 2023 by - Myasthenia Gravis

UCB receives CHMP positive opinion for rozanolixizumab for treatment of adults with generalized myasthenia gravis in Europe

  • The Committee for Medicinal Products for Human Use (CHMP) positive opinion1 is based on the pivotal Phase 3 MycarinG study in generalized myasthenia gravis (gMG) in adult patients,2 which demonstrated treatment with rozanolixizumab resulted in statistically significant and clinically meaningful improvements in gMG-specific outcomes compared to placebo,2 including everyday activities such as breathing, talking, swallowing, and being able to rise from a chair3
  • If approved by the European Commission, rozanolixizumab will be the first emerging therapy approved in Europe for adults with both anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody-positive gMG, the two most common subtypes of gMG 
  • The decision follows CHMP positive opinion for UCB’s zilucoplan in Europe for the treatment of adult patients with gMG earlier this year, alongside similar U.S. FDA and Japanese MHLW approvals of rozanolixizumab and zilucoplan for the treatment of gMG in adult patients4,5,6,7
  • UCB is the first and only company to offer a gMG-focused portfolio, providing patients and clinicians the option of two targeted therapies for both anti-AChR and anti-MuSK antibody-positive gMG

10th November 2023; UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorisation for rozanolixizumab as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.1 

Rozanolixizumab 140 mg/ml solution for injection is a humanised IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.2 If approved by the European Commission, rozanolixizumab will be the first emerging therapy approved in Europe for adults with both anti-AChR and anti-MuSK antibody-positive gMG, the two most common subtypes of gMG.

In September 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) also issued a positive opinion recommending granting marketing authorisation for UCB’s zilucoplan in the European Union (EU) as an add-on to standard therapy for the treatment of gMG in adult patients who are anti-AChR antibody-positive4. Zilucoplan is a once-daily subcutaneously (SC)-injected, self-administered peptide inhibitor of complement component 5 (C5 inhibitor).8

In progressing a portfolio of medicines for the treatment of gMG, with the aim of providing HCPs the option of addressing either complement activation or pathogenic antibodies for appropriate patients, UCB hopes to offer a comprehensive portfolio of targeted therapeutics, embodying a commitment to addressing the gMG community’s unmet needs.

There is a significant need to bring more targeted, well-tolerated, effective treatment options that address the pathophysiology of gMG disease. If approved by the European Commission, UCB will be the first and only company to offer a gMG-focused portfolio with rozanolixizumab and zilucoplan, providing patients and clinicians the option of two targeted therapies. We believe that the inclusion of both anti-muscle-specific tyrosine kinase (MuSK) antibody positive patients and anti-AChR positive patients within the CHMP marketing authorization recommendation for rozanolixizumab could support clinicians to tailor their prescribing decisions to meet individual needs of their patients. This latest European gMG regulatory milestone, alongside approvals for both zilucoplan and rozanolixizumab in the U.S. and Japan in recent months, further reinforces the commitment we have made to the gMG community to help transform their experiences, outcomes and expectations. We are truly proud and excited for the future.”

IIris Loew-Friedrich, Executive Vice-President and Chief Medical Officer at UCB

The CHMP opinion for rozanolixizumab is supported by safety and efficacy data from the pivotal Phase 3 MycarinG study (NCT03971422), published in The Lancet Neurology in May 2023.2 The primary efficacy endpoint was the comparison of the change from baseline between treatment groups (rozanolixizumab 7mg/kg, rozanolixizumab 10mg/kg) or placebo in the MG-ADL score at Day 43. MG-ADL is a measurement tool that assesses the impact of gMG on daily functions of 8 items that are typically affected in gMG. These include activities such as breathing, talking, swallowing, and being able to rise from a chair.3 Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. A total score ranges from 0 to 24, with the higher scores indicating more impairment. Reductions in MG-ADL score from baseline to Day 43 were greater in the rozanolixizumab 7 mg/kg group (least-squares mean change –3.37 [SE 0.49]) and in the rozanolixizumab 10 mg/kg group (–3.40 [0.49]) than with placebo (–0.78 [0.49]; for 7 mg/kg, least-squares mean difference −2.59 [95% CI −4.09 to −1.25], p<0.001; for 10 mg/kg, −2.62 [−3.99 to −1.16], p<0.001).2

Secondary efficacy endpoints included change from baseline to Day 43 in the Myasthenia Gravis Composite (MG-C) and the Quantitative Myasthenia Gravis (QMC) scores. The MG-C is a 10-item instrument that measures the symptoms and signs of MG based on physician examination and patient history. Items are related to ptosis, double vision, eye closure, talking, chewing, swallowing, breathing, neck flexion, shoulder abduction, and hip flexion. Each item is scored on an ordinal scale with four possible categories and weighted. The total score ranges from 0 to 50, with higher scores indicating more severe impairments. The MG-C is composed of items originating from other scales (i.e., QMG, MMT, MG-ADL). A statistically significant difference favoring rozanolixizumab compared to placebo was observed in the MG-C score change from baseline to Day 43 [least squares mean difference] -3.90 (95% CI (−6.63 to −1.25), p<0.001 for rozanolixizumab 7mg/kg; least-squares mean difference −5.53 (95% CI −8.30 to −2.97), p<0.001 for rozanolixizumab 10mg/kg.2 

The QMG is a 13-item categorical grading system that assesses muscle weakness. Each item is assessed on a 4-point scale where a score of 0 represents no weakness and a score of 3 represents severe weakness. A total possible score ranges from 0 to 39, where higher scores indicate more severe impairment.9 A statistically significant difference favoring rozanolixizumab compared to placebo was observed in the QMG total score change from baseline to Day 43 [least squares mean difference -3.48 (95% CI (−5.61 to −1.58), p<0.001 for rozanolixizumab 7mg/kg; least-squares mean difference −4.76 (95% CI −6.82 to −2.86), p<0.001 for rozanolixizumab 10mg/kg.2 

The most common adverse reactions (reported in at least 10% of patients treated with rozanolixizumab) were headache, diarrhea and pyrexia.1 

gMG is a rare, chronic, heterogeneous, unpredictable autoimmune disease characterised by dysfunction and damage at the neuromuscular junction (NMJ).10,11,12 gMG has a global prevalence of 100–350 cases per every 1 million people.11 

“With the news of the CHMP’s positive opinion of rozanolixizumab, we are very proud and excited to potentially provide the gMG community with further treatment options and new hope. Following recent approvals in the U.S. and Japan, it is our commitment to bring widespread access of innovative treatment options to a broader patient population living with myasthenia gravis. And, with our two different medicines for gMG, each with a distinct mechanism of action, UCB offers the community a unique portfolio of treatments that embodies our commitment to addressing the gMG community’s unmet needs.” said Jean-Christophe Tellier, CEO, UCB. “We would like to take this time to extend our gratitude to the patients, care partners and investigators who participated in the MycarinG study, and to our employees and collaborators for their dedication and support to the gMG community.” 

This announcement follows approval of rozanolixizumab and zilucoplan by the Japanese Ministry of Health, Labour and Welfare (MHLW) for treatment of gMG in adult patients (only for patients who inadequately respond to steroids or other immunosuppressants), and approval of rozanolixizumab by the U.S. Food and Drug Administration (FDA) for the treatment of gMG in adult patients who are anti-AChR or anti-MuSK antibody positive.7,5 Orphan designation was granted by the European Commission in 2020 to rozanolixizumab for the treatment of myasthenia gravis and successfully maintained after having received the positive CHMP Opinion.13 

The CHMP’s positive opinion for rozanolixizumab is now being reviewed by the European Commission, which grants centralised marketing authorisations for medicinal products in the EU. Feedback from the European Commission is anticipated during Q1 2024. 

References

  1. EMA CHMP Confirmation. Data on file, UCB November 2023.
  2. Bril V. Efficacy and safety of rozanolixizumab in patients with generalised myasthenia gravis: a randomised, double-blind, placebo-controlled, adaptive Phase 3 study MycarinG study. Lancet Neurol. 2023;22(5):383-94
  3. Wolfe Gl, et al. Myasthenia gravis activities of daily living profile. Neurology. 1992;52(7):1487-9
  4. CHMP Positive Opinion: Zilbrysq https://www.ema.europa.eu/en/medicines/human/summaries-opinion/zilbrysq. Date accessed November 2023
  5. RYSTIGGO® U.S. Prescribing Information
  6. ZILBRYSQ® U.S. Prescribing Information.
  7. Data on file: Japan MHLW, 25 September 2023.
  8. Howard JF Jr, et al. Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Neurol. 2023;22(5):395-406. 
  9. Regnault A, et al. Measuring Overall Severity of Myasthenia Gravis (MG): Evidence for the Added Value of the MG Symptoms PRO. Neurol Ther. 2023; 12:1573–1590.
  10. National Institute of Neurological Disorders and Stroke. 2022. Myasthenia Gravis Fact Sheet. https://www.ninds.nih.gov/health-information/disorders/myasthenia-gravis?search-term=myasthenia%20gravis%20fact%20sheet. Date accessed November 2023
  11. Punga AR, et al. Epidemiology, diagnostics, and biomarkers of autoimmune neuromuscular junction disorders. Lancet Neurol. 2022;21(2):176-88.
  12. Howard JF. Myasthenia gravis: The role of complement at the neuromuscular junction. Ann N Y Acad Sci. 2018;1412:113-128.
  13. European Medicines Agency. 2020. EU/3/20/2272: Orphan designation for the treatment of myasthenia gravis. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3202272. Date accessed November 2023
  14. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=699319. Date accessed November 2023.
  15. Myasthenia Gravis Foundation of America. MG Quick Facts. https://myasthenia.org/MG-Education/MG-Quick-Facts. Date accessed November 2023
  16. Juel VC, Massey JM. Myasthenia gravis. Orphanet J Rare Dis. 2007;2:44.

Advanced Parkinson’s disease: NICE backs treatment

Posted on November 7, 2023 by - Parkinson’s Disease

27 October, 2023: The National Institute for Health and Care Excellence (NICE) has recommended a treatment for advanced Parkinson’s disease that could benefit approximately 900 patients in England. This was the first technology appraisal from NICE to look at a treatment for Parkinson’s disease.

Final draft guidance suggests that foslevodopa–foscarbidopa (Produodopa, AbbVie) should be an option for treating advanced levodopa-responsive Parkinson’s disease in adults whose symptoms include severe motor fluctuations and hyperkinesia or dyskinesia.

Treatment will be an option when available medicines are not working well enough, and only if patients cannot have apomorphine or deep brain stimulation, or these treatments no longer control symptoms.

The treatment is administered subcutaneously via an infusion pump.

NICE noted that there is some uncertainty in the treatment effects, which could lead to the benefits of foslevodopa–foscarbidopa being overestimated. It also considered that the cost-effectiveness estimates for foslevodopa–foscarbidopa were uncertain. 

However, NICE acknowledged the high level of the unmet need – and the many potential benefits of the treatment – and recommended it.

NICE say that patients already receiving the treatment can continue without any change to the funding arrangements in place before publication of the guidance until they and their NHS clinician considered it appropriate to stop.

Final guidance is expected on 29 November, 2023. [UPDATE: See Overview | Foslevodopa–foscarbidopa for treating advanced Parkinson’s with motor symptoms | Guidance | NICE]

Foslevodopa–foscarbidopa represents an important new treatment for people with advanced Parkinson’s, providing an easy-to-use option that can help them manage their symptoms more reliably and effectively.

Helen Knight, Director of Medicines Evaluation at NICE

AI medical devices – MHRA to launch the AI-Airlock

Posted on November 6, 2023 by - Artificial Intelligence

Regulatory sandbox for AI developers will assist in the development and deployment of software and AI medical devices, safely providing patients with earlier access to cutting edge innovations that improve care.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced it is taking forward its new ‘regulatory sandbox’, the AI-Airlock, that will provide a regulator-monitored virtual area for developers to generate robust evidence for their advanced technologies.

AI medical devices via MHRA AI-Airlock

Artificial Intelligence in healthcare represents the exciting potential to improve patient outcomes in many ways, for example through improving diagnoses and treatment selections, optimising medication dosages, and providing enhanced personalised care for patients. 

However, technologies like these can sometimes be challenging to test using traditional trial techniques and would therefore benefit from the AI-Airlock project’s collaborative approach to identifying and managing evidence requirements.

This means patients could benefit from faster access to developing technologies such as improved diagnostics or precision medicine as a result of this announcement.

This partnership between government, regulators and industry will see advanced AI technology used in NHS settings, with strict safety controls, ahead of navigating regulatory approval. Where successful, the AI-Airlock will help NHS patients to benefit earlier from emerging technologies before they are available anywhere else in the world.

This will support innovators to work within the current regulatory system, identify where their products need to build more evidence needed for a safety and efficacy assessment and help resolve these issues.

It follows a robust process, so manufacturers of software and AI medical devices understand and deliver what is required to ensure the real-world viability of these devices.  The process, following the ‘regulatory sandbox’ model is a world-leading mechanism to assist in safe development and deployment of software and AI medical devices.

This learning can then be shared, helping to provide an evidence base that promotes a wider understanding of the challenges and potential solutions that are available.

The AI-Airlock is designed to be a collaborative space, bringing together expertise from innovators, regulatory organisations including Approved Bodies, Government, the NHS and academia.

The recent announcement of government funding from the Department of Science, Innovation and Technology and the Department of Health and Social Care will enable development of the service, so that it will be ready to launch in April 2024.

Dr Paul Campbell, MHRA Head of Software and AI said, “Building on the success of the regulatory sandbox, we are excited to deliver a new, world-leading methodology to support safe early access to AI for patients and healthcare. We need to ensure that AI is safe and properly regulated, but in a way that doesn’t stifle innovation and access to the latest of medical technologies to improve patient care. The deployment of AI and machine learning enabled med-tech devices is challenging, given the level of complexity of these products. However, by moving beyond conventional product concepts and associated regulations, sandboxes like the AI-Airlock offer a unique and safe learning space for manufacturers to work with regulators and other parties to explore new, cutting-edge solutions to help resolve these challenges. The new AI-Airlock scheme run by the MHRA will give us answers about how best to provide safe and effective products, such as AI-driven medical devices, to the NHS and patients.”

The NHS is already a leader in the testing of new AI technologies, and I am proud that we are now funding and collaborating on this new initiative with the MHRA to help move the dial even further, to bring the latest state-of-the-art AI and its benefits to the NHS and patients faster.”

Dominic Cushnan, NHS England AI, Imaging & Deployment Director

Could shared medical appointments increase patient engagement?

Posted on November 2, 2023 by - Uncategorised

New research from ESMT Berlin finds that shared medical appointments increase engagement from patients as they ask more questions, make more comments, and exhibit higher levels of nonverbal engagement, providing greater value for other patients in the sessions.

One-on-one service delivery is often considered ideal, with individualised attention assumed to improve client outcomes. In shared service delivery, clients are served in batches, and it is feared that loss of privacy and personal one-on-one connection might undermine patient engagement. However, in the setting of eye care delivery this research shows that might not necessarily be the case.

Nazlı Sönmez from ESMT Berlin; Kavitha Srinivasan and Rengaraj Venkatesh from Aravind Eye Hospital in India; Ryan W. Buell from Harvard Business School; and Kamalini Ramdas from London Business School conducted research to understand the impact of shared medical appointments (SMAs) on patient engagement. In SMAs, patients meet with the physician in a group, each receiving attention in turn. The physician shares information specific to individual patient needs while also sharing information relevant to others with the same condition.

The researchers conducted a randomised controlled trial at the Aravind Eye Hospital with 1,000 patients undergoing glaucoma treatment over a three-year period. Groups of five patients were assigned to attend one-on-one appointments or SMAs, with each attending a total of four appointments scheduled four months apart. Using verbatim and behavioural transcripts from video recorded during the trial, researchers examined how SMAs impact patient engagement.

These results exhibit the potential for shared service delivery to increase client engagement and enhance service performance, particularly within healthcare. The design of SMAs enables patients to spend more time with the physician, albeit alongside other patients. Providers also spend more time with each patient, over 600% more time in this study, a driver of quality and value.

On average, per minute, a patient who experienced SMAs asked 33.3% more questions and made 8.6% more non-question comments. With multiple patients in an SMA, an increase in engagement resulted in patients hearing far more comments in the group setting.

Patients in SMAs also exhibited higher levels of nonverbal engagement on a wide array of measures including attentiveness, positivity, head wobbling (a South Indian gesture to signal agreement or understanding), eye contact, and end-of-appointment happiness.

“Our analysis sheds light on the benefits of designing service models that enable customers to be more helpful in serving one another, leading to more efficacious service encounters in healthcare and beyond,” says Nazlı Sönmez, Assistant Professor of Management Science at ESMT. “During our trial, our physician partners observed patients in SMAs who became motivated to ask particular questions by hearing the questions and comments of other patients.”

This research was published in the journal Manufacturing and Services Operations Management and can be viewed here.

Ipsen and World Stroke Organisation partnership focuses on improving post-stroke care

Posted on October 30, 2023 by - Stroke

Research highlights financial challenges and knowledge gaps faced by stroke survivors

Results of a new Ipsen survey highlight the stark reality faced by stroke survivors, revealing the personal and financial burdens that stroke can have on individuals and their families. The survey raises critical concerns, suggesting that many stroke survivors are not proactively made aware by their neurologist of the long-term complications that can occur following a stroke.

The survey of over 500 stroke survivors found that 9 in 10 (90%) people who were employed at the time of their stroke, said it has had an impact on their working life. One in four (25%) stroke survivors stated they have had to leave their jobs and 1 in 3 (34%) said they had to reduce their work hours.  Data shows that younger stroke survivors are particularly hard hit in terms of the impact on their careers and livelihoods, as for those who said that they had to reduce their working hours, close to half (45%) were aged 30 to 44. Similarly, of those who said they had to leave work altogether, more than a third (34%) were 30 to 44 and of the stroke survivors who said they had to find alternative employment, almost six out of ten (59%) were aged 30-44.

In addition, findings highlight that stroke also heavily impacts family members’ ability to work. Almost three quarters (74%) of all individuals who have experienced a stroke in the past three years report that a family member has had to either give up or reduce their working hours to provide care and assistance. In the UK specifically, one in five (21%) said a family member had to give up their job long-term (over a year) to care for them, while one in four (25%) said they had to reduce their work hours.

Announcing a global partnership between Ipsen and the World Stroke Organisation, focused on improving post-stroke care, Michelle Nelson, VP of Stroke Support Organizations of the World Stroke Organization said “Increasing global stroke rates among those under age 55, coupled with a projected 35% rise in stroke survivors in Europe by 2040, will significantly impact the global economy. Without action, stroke-related costs, including direct expenses and income losses, are estimated to rise to $2.31 trillion worldwide by 2050. It is therefore vital that we ensure that stroke survivors and their families have access to good quality post-stroke services to prevent recurrent strokes and optimize health and wellbeing post stroke.”

As clinicians we sometimes face significant obstacles to efficient care delivery due to a lack of patient awareness of critical symptoms of post-stroke complications and clear lines of communication between physicians, stroke survivors and caregivers. Timely and comprehensive care is vital for optimising long-term health outcomes post-stroke, particularly when it comes to spasticity. Ensuring stroke survivors are made aware and have access to accurate information and support post-discharge is critical to the success of rehabilitation.

Dr Ganesh Bavikatte, Consultant and Clinical Lead, UK

When respondents were asked what they hoped their post-stroke treatment and rehabilitation programme would deliver, almost half of all individuals questioned said the prevention of another stroke (49%). A similar proportion (46%) said they wanted to improve their mobility and movement, highlighting the high value that patients place on being able to move freely.

Despite being a top priority for patients, the survey uncovered a concerning gap in care: at least one in three stroke survivors reported that they were not proactively informed by their neurologists about potential post-stroke complications, including mobility issues such as muscle stiffness (spasticity) (38%) and muscle weakness (paresis) (38%). In addition, in Europe 1 in 3 (33%) stroke survivors who do not primarily see a stroke specialist regarding their post-stroke care, say their general practitioner does not refer them to see a stroke specialist when they experience new stroke related complications.

The findings highlight the need for a comprehensive approach to long-term stroke management that limit the economic impact and alleviates the multifaceted burdens faced by survivors and their families.

“Delayed and uncoordinated post-stroke care is costly for patients, society and healthcare systems. We know that many patients are not referred for rehabilitation and post-stroke care in a timely manner,” explains Dr Sandra Silvestri, Chief Medical Officer at Ipsen. “Ipsen is committed to improving stroke outcomes for patients. As part of this commitment, we are currently conducting a major scientific study in over 1000 patients in 7 countries to fully assess the incidence, timing, severity and patterns of post-stroke spasticity so that better treatment pathways can be identified globally for patients.”