hheadmin, Author at Hospital Healthcare Europe

Press Releases

Take a look at a selection of our recent media coverage:

Expert view: Beyond TNF-alpha – differentiating PsA and RA

26th March 2019

Psoriatic disease is a chronic inflammatory systemic condition characterised by psoriasis, which affects up to 3% of the general population, and in about 30% of cases, by psoriatic arthritis (PsA), which may also be diagnosed in the absence of a personal history of psoriasis.

From a clinical and immunological standpoint, psoriasis and PsA represent a continuum within a prototype for chronic inflammation, but largely different from rheumatoid arthritis (RA), although both lead to reduced quality of life and elevated risk of malignancy, cardiovascular disease, and depression. Patients with psoriatic disease often manifest other chronic inflammatory comorbidities and associated conditions, well represented by inflammatory bowel disease and uveitis.

In contrast to RA, no serum autoantibody is associated with PsA, whereas other biomarkers have been proposed for early diagnosis of the disease or to predict treatment response for a more adequate resource allocation. From a clinical standpoint, the manifestations of PsA are widely variable and only partially overlap with RA; particularly as only PsA affects the spine, thus being defined as spondyloarthritis. Despite numerous improvements in the management of PsA, there remain numerous unmet needs.

First and foremost, there is a significant unmet need for reliable tools for the early diagnosis of PsA in psoriasis. Our current understanding of the probability of developing PsA in psoriasis or to achieve an early diagnosis could be defined as primitive, with limited agreement on the clinical manifestations to be sought. Despite the presence of an obvious risk factor for PsA in the skin manifestation, the individual clinical judgment and medical history remain the sole driver of PsA screening, which differs from RA with serum autoantibodies specific for the disease and pre-dating overt clinical manifestations.

Predicting an effective and safe medication to manage the disease is another significant challenge, and currently approximately 40% achieve meaningful responses such as minimal disease activity status with second- or third-line treatments. These two unmet needs result in the major unmet need, that is, the necessity for early treatment that will minimise the risk of disease progression along with the costs and with an optimal safety profile. One putative solution for this moves from a multidisciplinary approach, which includes foremost dermatology and rheumatology specialists, and this is certainly also a goal in RA.

Expert view: Beyond TNF-alpha - differentiating PsA and RA

Autoimmune diseases are related to each other, but some more than others

Researchers using the world’s largest twin registry to study seven autoimmune diseases found the risk of developing the seven diseases is largely inherited, but that some diseases are more closely related than others.

“These results contribute to our understanding of what causes autoimmunity and how autoimmune diseases are related,” said Jakob Skov MD, the study’s lead investigator and a PhD student at the Karolinska Institute in Stockholm, Sweden. “We examined the risk of acquiring not only one specific disease, but any one in a cluster of conditions. The findings may be helpful in patient education and autoimmune risk counselling.”

By using data on 116,320 twins from the Swedish Twin Registry, which is managed by the Karolinska Institute, they found that Addison’s disease, a type of adrenal insufficiency; coeliac disease, or gluten intolerance; and Type 1 diabetes, are strongly influenced by genes with heritability greater than 85%, while environmental factors contribute to disease for Hashimoto’s hypothyroidism, a form of underactive thyroid; the skin disease vitiligo; Graves’ disease, an overactive thyroid; and atrophic gastritis, a chronic inflammation of the stomach.

Autoimmune clustering was high in Addison’s disease and vitiligo, the researchers found, but low in coeliac disease.

“Our results indicate that Addison’s disease and vitiligo often overlap with other disorders, whereas coeliac disease more rarely associates with the other diseases,” Skov said.

Autoimmune diseases are related to each other

Bringing a new generation of drugs to patients

22nd March 2019

Cardiff University is stepping up the development of new drugs for mental health and central nervous system conditions, with the launch of the Medicines Discovery Institute.

Focusing on areas of unmet clinical need, the new institute will develop novel medications to improve the lives of people across the world.

Part funded by the Welsh Government, the Higher Education Funding Council for Wales and the European Regional Development Fund, the £14 million centre aims to put Wales at the forefront of medical innovation.

The Institute, which is located within the highly successful School of Biosciences, will also provide an excellent opportunity for training and inspiring the next generation of medicines discovery scientists.

One of the Institute’s first big projects will focus on improving anxiety medications – an area of research where there have been no major advances since early 1960. Thanks to a major investment of £3.5 million from the Medical Research Council, the team will focus on the development of drugs that reduce the side effects associated with the benzodiazepine class of anxiolytic drugs.

Another new grant from the MRC will allow the team to develop improved medication options for people with fragile X syndrome – the most common inherited cause of learning disabilities. Focusing on a protein known to regulate the connections between nerve cells, the team aim to develop a novel medication that will make a difference to the lives of individuals and their families living with the condition.

The Education Minister, Kirsty Williams, said: “Investing in new scientific research is vital to our universities and the long-term health of the wider Welsh economy. Our £95m Sêr Cymru programme is instrumental in keeping Wales ahead of the game in many areas of scientific innovation.

“The Medicines Discovery Institute will provide the world-class facilities needed to support pioneering research and further develop our capacity to produce exciting and often life-changing research here in Wales.”

Peter Halligan, the Chief Scientific Adviser for Wales, said: “I am really pleased to be involved in the launch of the Medicines Discovery Institute as it provides another opportunity to demonstrate how the Sêr Cymru programme continues to contribute to Wales’s growing research capacity. The discovery and development of new drugs and diagnostics is a challenging area which takes many years, but has the potential to impact the lives of patients world-wide.

“The Medicines Discovery Institute represents a further step forward in the Welsh Government ambition for making high quality, productive, impactful research happen in Wales, and in the process ensure that Wales remains competitive in the global economy. The Sêr Cymru programme is working towards creating a step change in research capacity and locating Wales firmly on the map as a centre of scientific discovery.”

Professor Simon Ward, Director of the Medicines Discovery Institute, said: “Patients are at the centre of the vision for our institute. Our ultimate aim is to reduce the impact on patients, families and society of mental health and neurodegenerative disorders by translating advances in our disease understanding into new drugs.

“We also intend to use our drug discovery capabilities to work with colleagues across Cardiff University to address other unmet medical needs, such as cancer.

“Our Institute is multidisciplinary, bringing together experts from many scientific disciplines so that we can work together to discover new medicines.

“We are building on our successful and established reputations at drug discovery scientists, with extensive experience in industry and academic research to develop new treatments for patients.”

Professor John Atack, Co-Director of the Medicines Discovery Institute, added: “At the Medicines Discovery Institute, we are bringing together world-leading scientists to help identify new drug candidates.

“The exceptional scientific environment within the Cardiff area means we are ideally placed to translate basic science into patient benefit.”

Anxiety UK Chief Executive Nicky Lidbetter said: “The launch of the Medicines Discovery Unit at Cardiff University is a welcome development that will provide state of the art facilities to support the development of new treatments and medications for a range of conditions including anxiety disorders. We are already linked in with the work being undertaken by Prof John Atack in developing the next generation of benzodiazepines and welcome this and indeed new research on anxiety disorders as historically this area of mental health has not received the research attention that it deserves in spite of such disorders being so prevalent in society.”

Bringing a new generation of drugs to patients

Universities create innovative lab test to develop easy to swallow medicine for children

21st March 2019

In an article published by the European Journal of Pharmaceutical Sciences, scientists compared traditional sensory tests and a new in vitro method that was able to explain why smaller multiparticulates eased the travel of medicine from the mouth into the throat and body, reducing mouth residue.

The test let scientists easily screen different compositions of the carrier liquid and concentration of the particulates, in order to make swallowing as easy as possible.

Dr Marco Ramaioli, Senior Lecturer at the University of Surrey and co-author of the study, said: “Many young children and older people find conventional tablets hard to swallow – making it difficult for them to complete drug therapy. We hope that this in vitro method, together with sensory tests, will help to develop novel medicines that could improve the lives of many people across the world.”

Professor Catherine Tuleu from UCL School of Pharmacy commented: “It is exciting to see advancements in age appropriate medicine design such as multiparticulate systems but successful therapeutic outcomes rely on the development of appropriate administration vehicles.”

Dr Mine Orlu, also from UCL School of Pharmacy, added: “The availability of predictive models to characterise the promising formulation platforms early during medicine development is key to producing medicines that are easier to take for patients with different swallowing capabilities.”

Universities create innovative lab test to develop easy to swallow medicine for children

Could IBS symptoms be undiagnosed coeliac disease?

20th March 2019

With only 3% of British adults aware that the symptoms of IBS (irritable bowel syndrome) are also common symptoms of coeliac disease, Coeliac UK, is calling on greater awareness of the similarity of symptoms and urges anyone with IBS to ask their GP for a coeliac disease blood test, if they have not already had one.

As many as one in four people with coeliac disease were previously misdiagnosed with IBS as many of the symptoms for IBS such as bloating, stomach pains or cramps, diarrhoea or constipation and feeling exhausted are the same as the symptoms of coeliac disease.

Norma McGough, Coeliac UK director of policy, research and campaigns said: “It is essential that awareness of the similarity of the symptoms increases and that GPs adhere to the NICE (National Institute for Health and Care Excellence) guideline which states that anyone with IBS symptoms should be tested for coeliac disease before a diagnosis of IBS is made.”

Coeliac disease is not an allergy or an intolerance but an autoimmune disease where the body’s immune system damages the lining of the small bowel when gluten, a protein (found in wheat, barley and rye) is eaten. There is no cure and no medication; the only treatment is a strict gluten free diet for life.

1 in 100 people in the UK is estimated to have coeliac disease but of these, only 30% are currently diagnosed, meaning there are nearly half a million people in the UK with undiagnosed coeliac disease.

The average time it takes for someone to get a diagnosis is 13 years from the onset of symptoms; by which time, they may already be suffering with added complications caused by the disease. If left untreated, coeliac disease can lead to a number of serious complications, including: anaemia, osteoporosis, unexplained infertility, neurological conditions such as gluten ataxia and neuropathy, and although rare, there is an increased risk of small bowel cancer and intestinal lymphoma.

“The first step to diagnosing coeliac disease is a simple, inexpensive blood test done in primary care, but thousands of people are not getting the necessary testing and are being left undiagnosed including those with IBS symptoms. This not only causes years of unnecessary suffering but also wasted costs to the NHS with repeated appointments and investigations.

We urge anyone who has symptoms such as ongoing bloating, diarrhoea or constipation and has been given a diagnosis of IBS but not been tested for coeliac disease to ask their GP to test them for coeliac disease. However, it is essential to keep eating gluten until all tests are completed as otherwise these tests may give a false negative result,” continued Ms McGough.

Coeliac UK’s online assessment www.coeliac.org.uk/isitcoeliacdisease, based on the NICE guideline NG20, gives people greater confidence to seek further medical advice from their GP. Upon completion of the assessment, the respondent will receive an email with their results, which will indicate whether their symptoms are potentially linked to coeliac disease.

Could IBS symptoms be undiagnosed coeliac disease?

Groundbreaking pancreatic cancer trial reaches patient milestone

A groundbreaking pancreatic cancer trial, which aims to match patients with more targeted and effective treatment for their tumours, has successfully recruited its 100th patient.

Run by Precision-Panc, a research programme and clinical trials project led by the University of Glasgow with major funding from Cancer Research UK, the trial brings a precision medicine approach to pancreatic cancer treatment for the first time in the UK.

Pancreatic cancer is the fifth most common cause of cancer death in the UK with a 5-year survival rate of less than 3%. Around 9800 people are diagnosed with pancreatic cancer per year in the UK and around 9000 people die.

In December 2017 Precision-Panc began working alongside colleagues in NHS Greater Glasgow and Clyde Health Board to recruit suitable pancreatic cancer patients to the Precision-Panc Master Protocol at Glasgow Royal Infirmary.

The Glasgow-born project has been so successful in the last year, it has now been rolled out to 16 sites across the UK, offering potential treatment hope for pancreatic cancer patients nationwide.

As part of the protocol, each patient undergoes tumour biopsy to obtain material that is then used for molecular profiling at the Glasgow Precision Oncology Laboratory (GPOL) within the University of Glasgow. The results may then be used to help match patients to the most appropriate, currently available clinical trial.

This ability to link clinical data with the patient’s unique molecular profiling data enables rapid new discoveries, and enhances the delivery of precision medicine to current and future patients.

Professor Andrew Biankin, Chief Investigator of Precision-Panc and Regius Chair of Surgery and Director of the University of Glasgow Wolfson Wohl Cancer Research Centre, said: “I am extremely proud of what we have been able to achieve so far with Precision-Panc. Recruiting the 100th patient is a milestone for us and signals our ability to make real changes to the lives and survival rates of patients with pancreatic cancer.

“The success we have achieved so far – including opening 17 sites across the country – is testament to what we are able to achieve and deliver for patients as a team.”

The overall aim of Precision-Panc is to make precision medicine a reality for more people with pancreatic cancer through building up knowledge that will ultimately allow clinicians to match patients with the most suitable treatment or clinical trial for them. The project aims to facilitate drug development, and ultimately new drug approval, allowing access and improving survival in patients with pancreatic cancer.

Dr Ian Walker, Director of Clinical Research at Cancer Research UK, said: “To make real progress in improving survival for people with pancreatic cancer, we need to understand which drugs will be most likely to provide benefit for individual patients. Through Precision-Panc, we are looking to do just that, and recruiting 100 patients is a huge landmark for this ambitious study.

“While overall survival from cancer has doubled over the last 40 years, pancreatic cancer has only seen little improvement, and too many people die from the disease each year. Innovative studies like Precision-Panc are vital to changing the outlook for these patients and we look forward to seeing how it continues to progress.”

Groundbreaking pancreatic cancer trial reaches patient milestone

Pharmacists have wider clinical role in A&E, concludes study

19th March 2019

The first evaluation of pharmacists based in accident and emergency departments has concluded that with additional clinical skills, they are able to take on overall clinical responsibility for patients.

Daniel Greenwood, a PhD student from The University of Manchester, UK, studied the work of people they termed Emergency Department Pharmacist Practitioners (EDPPs) from 15 NHS Trusts across the UK over 10 days.

The research, published in the International Journal of Clinical Pharmacy, observed the care they provided to 682 patients, and their contribution to the wider department, using an iPad-based questionnaire.

Because A&E doctors and nurses are in short supply, hospitals have started to employ pharmacists who have additional clinical skills to help deliver services since 2015.

Eleven EDPPs took on the role of designated care provider for at least some of their patients.

All 20 EDPPs carried out both ‘traditional’ and ‘practitioner’ activity; 9 of them sometimes provided more ‘practitioner’ than ‘traditional’ care to individual patients.

Of all 682 patients, EDPPs examined 264 (38.7%) and diagnosed 238 (34.9%).

Daniel Greenwood said: “This study shows that Emergency Department Pharmacist Practitioners can combine traditional clinical pharmacy with more hands-on medical practice including being designated care provider.

“No other A&E professional has the same medicines expertise.

“EDPPs who work as a designated care provider can fill gaps in doctor and nurse practitioner rotas, something that can only be welcomed given ongoing staff shortages.

“But they can also provide pharmaceutical care that is lacking in some departments, such as checking prescriptions.

He added: “The EDPPs we studied performed a wide range of rolls including performing or reviewing clinical examinations, diagnosis, prescribing, treatment and discharge.

“They worked as members of multidisciplinary teams, supporting and being supported by others. And they often took on overall responsibility as the patient’s designated care provider.

“There is no doubt that pharmacists with additional clinical skills training have a role to play in A&E departments.”

Pharmacists have wider clinical role in A&E

Expert view: Who is at risk of severe allergic reactions?

18th March 2019

Allergies are a major ongoing problem, especially in Western countries. Currently, it is estimated that about a quarter of the world’s population suffers from some type of allergy, mainly due to allergic rhinitis or allergic bronchial asthma.

However, the most dangerous reactions (anaphylaxis) usually occur through allergic reactions to foods, drugs and Hymenoptera (for example, wasps, bees, ants, etc) bites.

The Big Eight

Food allergies typically occur in childhood, but can persist, or even first occur, in adulthood. The foods most frequently responsible for allergic reactions are the ‘big eight’, namely: milk, eggs, fish, shellfish, soy, wheat, peanut and walnuts. Not all food allergies cause serious reactions; in fact, the intensity of the reaction depends on many factors, such as the sensitivity of the subject, the amount of ingested food, if it was raw, cooked or processed industrially (cooking and industrial processing can reduce the risk as they destroy certain types of allergens), and the health status of subject, including concomitant diseases and therapies.

Drug allergies

Allergic reactions to drugs are rarer, and occur more typically in adulthood. In these cases, reactions can be mild or more severe reactions. The most implicated drugs are antibiotics (especially the penicillin family) and non-steroidal anti-inflammatories. Subjects having had a previous adverse reaction to drugs (even if not severe) or even a suspected reaction should advise their clinician, who will advise on the proper diagnostic route to confirm or rule out the diagnosis and, if necessary, identify the drugs that patient can use safely.

Insect bites and allergies

Allergies to Hymenoptera bites mainly occur in adulthood; most at risk for these reactions are beekeepers, followed by all those who, for reasons related to work, hobbies or lifestyle can easily be stung by Hymenoptera. People who have presented a systemic reaction (shortness of breath, feeling lightheaded/syncope, intestinal symptoms, hives, etc) after a bee, wasp or hornet sting, or an extended local reaction (redness and swelling in a 10cm radius of site of the sting) are to be considered at risk of a severe reaction in case of future stings and should undergo an allergological diagnostic workup.

In subjects at a high risk of serious allergic reactions, the physician will prescribe emergency therapy with an ephineprine auto-injector, which should be carried by the patient at all times.

Expert view: Who is at risk of severe allergic reactions?

First study in PAH using cardiac MRI as a primary endpoint presented

Actelion has announced an interim analysis from the Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension (REPAIR) study of Opsumit^® (macitentan) that shows treatment with macitentan in patients with pulmonary arterial hypertension (PAH) was associated with significant improvements in right ventricular (RV) function, including reversal of RV remodelling and reduced pulmonary vascular resistance (PVR).

The data were presented at the American College of Cardiology’s 68th Annual Scientific Session.

“The REPAIR study is the first multicentre study in PAH to use a primary endpoint measured by cardiac MRI,” said Stephan Rosenkranz, MD, Head of Pulmonary Hypertension Center and Head of Cologne Cardiovascular Research Center (CCRC), University of Cologne, Division of Cardiology. “These results offer clinicians who treat this severe and progressive disease a better understanding of the effects that macitentan can have on RV remodelling and function in patients with PAH.”

The REPAIR study is a 52-week, open-label, multicenter study evaluating the effect of macitentan on RV remodelling and function as determined by cardiac magnetic resonance imaging (MRI) and right heart catheterisation. Macitentan was initiated as monotherapy or sequential combination therapy with a phosphodiesterase-type 5 (PDE-5) inhibitor, or as initial combination therapy with a PDE-5 inhibitor. The pre-specified interim analysis including 42 patients with PAH showed significant improvements in both primary endpoints including a mean increase of 15.2ml (p<0.0001) in RV stroke volume (RVSV) and a 37% reduction (p<0.0001) in PVR from baseline at Week 26, and the study was declared positive.¹ RVSV was determined by pulmonary artery flow MRI and PVR was measured by right heart catheterisation. A full evaluation, with focus on RV, was also performed using MRI.

“Measurement of RV function in patients with PAH is very helpful in monitoring response to treatment,” said Richard N Channick, MD, Professor of Medicine and Director, Acute and Chronic Thromboembolic Disease Program at UCLA Medical Center. “The REPAIR study shows us that RV function, as determined by MRI, is a relevant endpoint in studying treatment efficacy in PAH.”

Pulmonary arterial hypertension is a progressive disease in which blood vessels in the lungs become restricted. This forces the right heart to work harder to pump blood to the lungs, and RV function is impaired. The results from the REPAIR interim analysis suggest that treatment with macitentan is associated with significantly improved RV function as determined by MRI in patients with PAH. In the REPAIR study, the safety profile of macitentan was consistent with previous clinical trial data.²

“We are very pleased with these interim results from the REPAIR study and we will work diligently to report the full study results in the near future,” said Alessandro Maresta, MD, VP and Head of Global Medical Affairs at Actelion Pharmaceuticals Ltd. “We are committed to ongoing research and to advancing therapies for people with PAH and are proud to make a difference in patients’ lives.”

References

Rosenkranz S et al. J Am Coll Cardiol 2019;73(9 Supp 1)1898.
Pulido T et al. N Engl J Med 2013;369:809-18.

First study in PAH using cardiac MRI as a primary endpoint presented

Data from the Phase III UNIFI maintenance study announced at ECCO 2019

Janssen has announced new data from the Phase III UNIFI maintenance study.

The data showed that a significantly greater proportion of adults with moderate to severe ulcerative colitis (UC) receiving ustekinumab subcutaneous (SC) maintenance therapy were in clinical remission at Week 44, compared to patients receiving placebo – the study’s primary endpoint.¹ Patients receiving ustekinumab SC maintenance therapy had a clinical response 8 weeks after receiving a single intravenous (IV) dose of ustekinumab.¹

Results from the maintenance phase of the Phase III study demonstrated that 44% (90mg every 8 weeks [q8w]) and 38% (90mg every 12 weeks [q12w]) of patients with moderate to severe UC receiving ustekinumab SC injections achieved clinical remission, as defined by the Mayo score, at week 44 (52 weeks after IV induction) compared to 24% of patients who received placebo (p<0.001 and p=0.002, respectively).¹ These data were included in submissions to the European Medicines Agency and the US Food and Drug Administration seeking approval of ustekinumab as a treatment for UC.

“Ulcerative colitis is a disruptive, lifelong and potentially debilitating inflammatory bowel disease; however, it is a condition where remission is possible,” said lead study investigator William Sandborn, MD, Chief, Division of Gastroenterology and Professor of Medicine, University of California, San Diego. “The data suggest the potential of ustekinumab as an effective therapy for helping people living with ulcerative colitis achieve remission, as well as providing other meaningful outcomes, including clinical response, histo-endoscopic improvement and corticosteroid-free remission.”

Major secondary endpoints, including maintenance of clinical response, endoscopic improvement, corticosteroid-free remission and maintenance of clinical remission from baseline, were also achieved in greater proportions of patients receiving ustekinumab q8w and q12w injections versus patients receiving placebo. At week 44:

71% of patients receiving ustekinumab q8w and 68% of patients receiving ustekinumab q12w maintained clinical response, compared with 44% of patients receiving placebo (both p<0.001).¹ Clinical response was defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, with a rectal bleeding sub-score of 0 or 1 or a decrease in the rectal bleeding sub-score ≥1.
51% of patients receiving ustekinumab q8w and 44%of patients receiving ustekinumab q12w achieved endoscopic improvement, compared with 29% of patients receiving placebo (p<0.001 and p=0.002, respectively).¹ Endoscopic improvement was defined as a Mayo endoscopy sub-score of 0 (normal mucosa or inactive disease) or 1 (mild disease activity)
42% of patients receiving ustekinumab q8w and 38 percent of patients receiving ustekinumab q12w were in clinical remission and were corticosteroid-free, compared with 23% of patients receiving placebo (p<0.001 and p=0.002, respectively).¹ The global remission definition was a Mayo score ≤2 points, with no individual sub-score >1.

Through to week 44, the proportions of patients with adverse events (AEs), serious AEs, infections and serious infections in the ustekinumab groups were generally comparable to the placebo group. The proportions of patients who discontinued the study agent were lower with ustekinumab q8w and q12w versus placebo. Among the primary population in the maintenance study, no deaths occurred. Two malignancies other than non-melanoma skin cancer (NMSC) (one colon cancer, q8w; one papillary renal cell carcinoma, q12w) were reported. One patient reported NMSC (two squamous cell carcinoma events, q12w).¹ Overall, the safety for ustekinumab in UC patients was consistent with the known safety profile of ustekinumab in Crohn’s disease.²

“The UNIFI maintenance data further build the case for ustekinumab as a potential new treatment option for ulcerative colitis and illustrate our ongoing commitment to researching and developing meaningful therapies for people living with inflammatory bowel diseases,” said Scott E Plevy, MD, Gastroenterology Disease Area and IL-23 Pathway Leader, Janssen Research & Development, LLC. “Furthermore, we are proud that UNIFI is the first Phase III study to report a combined histo-endoscopic endpoint in patients with ulcerative colitis.”