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Take a look at a selection of our recent media coverage:
3rd May 2024
Exhaled breath analysis shows promise as a non-invasive approach for the therapeutic monitoring of antibiotics, a proof-of-concept study has found.
At the recent ESCMID Global Congress Barcelona, Spain (27-30 April), Swiss researchers presented the findings from the prospective, single-centre study of 10 adult hospitalised patients (median age 63 years, 54.5% female) who received intravenous antibiotic treatment in 2022 or 2023.
For patients with severe infections or in intensive care, therapeutic drug monitoring allowed clinicians to account for differences in how individuals metabolise drugs and was used to optimise and guide dosing.
First author Dr Sarah Dräger, senior physician in the Division of Internal Medicine at University Hospital Basel in Switzerland, said drugs were usually monitored through testing blood samples but the process was invasive, time-consuming and lead to patient discomfort.
‘It takes several hours or even days to get results, depending on the antibiotic tested, and so the results may come too late to guide the treatment of some of the sickest patients,’ she said.
In contrast, breath samples were easy to collect, Dr Dräger said, adding the method was non-invasive and not associated with patient discomfort.
The approach could also decrease turnaround times, with results potentially being available in 10 minutes.
‘[Exhaled breath analysis] is already used to monitor other drugs, such as antiseizure medicines, and we wanted to explore its potential in monitoring antibiotics,’ Dr Dräger said.
Patients in the study were being treated for respiratory infections (n=3), intravascular infections (n=3), abdominal infections (n=2), urinary tract infection (n=1) or skin and soft tissue infection (n=1).
The antibiotics used were meropenem (n=3), piperacillin/tazobactam (n=3), cefazolin (n=2), flucloxacillin (n=1) and ciprofloxacin (n=1), the researchers reported in a poster at the conference.
Plasma therapeutic drug monitoring samples were collected 0-60 minutes after the end of the antibiotic bolus infusion.
Some 30 minutes after the blood sample collection, researchers performed exhaled breath analysis using secondary electrospray ionisation (SESI) combined with high resolution mass spectrometry (HRMS).
SESI-HRMS, a real-time exhaled breath analysis technique, was characterised by a high sensitivity and broad metabolic coverage, including endogenous (breakdown products from the antibiotic) and exogenous (breakdown products from the body that are affected by the antibiotic) metabolites.
The breath analysis identified specific exhaled molecules associated with meropenem, cefazolin, flucloxacillin and ciprofloxacin, but there was no clear signal for piperacillin.
Dr Dräger concluded: ‘We were able to detect antibiotic-specific metabolites in exhaled breath in patients treated with antibiotics in four out of five antibiotics investigated.
‘We aim to confirm these very promising results in a larger cohort of patients, as well as look at how they relate to blood plasma concentrations of antibiotics and patient outcomes.’
Healthcare professionals prescribing montelukast as an oral add-on therapy for the treatment of asthma in patients aged six months or older should be alert to serious behaviour and neuropsychiatric reactions associated with the treatment, according to a new drug safety update.
This reminder about montelukast from the Medicines and Healthcare products Regulatory Agency (MHRA) comes after continued Yellow Card reports of a range of neuropsychiatric reactions such as sleep disorders, hallucinations, anxiety and depression, and changes in behaviour and mood.
A review of evidence by the MHRA concluded that while the risk of neuropsychiatric reactions with montelukast remains unchanged since its last Drug Safety Update on montelukast in 2019, the Yellow Card reports have indicated this risk is potentially not well known by healthcare professionals, patients and their caregivers.
Commenting on the review, Dr Alison Cave, MHRA chief safety officer, said: ‘Patient safety is our top priority. Throughout our review, we have listened to patient representatives and taken independent clinical advice from paediatricians, specialists in mental and respiratory health and experts from the Commission on Human Medicine’s Expert Advisory Groups.’
She added: ‘We have now taken regulatory action to update the leaflet included in all montelukast medicine packs in the UK with prominent warnings and advice about the risk of serious behaviour and mood-related changes.’
The MHRA is urging healthcare professionals to make patients and their caregivers aware of this information and encourage them to immediately speak to their prescriber or seek urgent medical attention if neuropsychiatric reactions occur while using montelukast.
The regulator also confirmed that the benefits of montelukast continue to outweigh the risks for most patients for the management of asthma and that this is under continuous review.
The risk of neuropsychiatric side effects has been included in the product information for montelukast since 2008, and following a European review in 2019, additional warnings about these risks were included in the EU and UK product information.
Last year, researchers found that prenatal leukotriene receptor antagonist use was not associated with a higher incidence of neuropsychiatric events in their offspring.
2nd May 2024
Patients with allergic rhinitis who take a liquid sublingual allergen immunotherapy (SLIT-liquid) have a significant reduction in the risk of asthma onset or worsening for up to eight years compared with patients taking symptomatic allergic rhinitis therapies alone, a large real-world study has found.
Allergic rhinitis affects 400 million people worldwide, with one third of these patients also having allergic asthma, the French researchers wrote in The Lancet Regional Health – Europe.
Current allergic rhinitis management strategies aim to control symptoms and reduce inflammation, with oral or nasal antihistamines or intranasal corticosteroids the recommended first-line treatments.
Allergen immunotherapy (AIT) – currently the only causal treatment option for allergic disease – might be indicated in combination with pharmacotherapy if the response to first-line therapies was inadequate or absent, researchers said.
AIT is recommended to be administered for at least three years, either subcutaneously or sublingually, with tablets or liquid formulations.
Randomised controlled trials and observational studies have confirmed the efficacy and safety of AIT in allergic rhinitis, with or without asthma, but data has been limited on the impact of AIT on asthma onset and worsening.
For the national EfficAPSI real-world study, researchers analysed a cohort of 112,492 people with allergic rhinitis who initiated personalised SLIT-liquid (brand name Staloral) and 333,082 controls who were dispensed allergic rhinitis symptomatic medication but had no history of receiving allergen immunotherapy.
Data on the control patients were taken from the French national health data system SNDS, with data on the exposed patients taken from the database of SLIT-liquid manufacturer Stallergenes Greer, which also funded the EfficAPSI study.
One third of patients in both groups had a history of mild-to-moderate asthma, the study authors noted.
Among the exposed patients, two thirds were treated for a single allergen, mainly house dust mites and grass pollen.
The median follow-up was 6.9 years for exposed patients and 8.2 years for the control group.
First author Professor Pascal Demoly, professor of pulmonology and head of department at the University Hospital of Montpellier, France, and co-authors said that they found a 36% reduction overall in the risk of new asthma events in patients treated with SLIT-liquid compared with controls.
SLIT-liquid exposure was associated with a significantly lower risk of asthma onset according to three definitions: combined: HR 0.64, sensitive: HR 0.76, and specific: HR 0.66.
The sensitive definition of asthma events considered the first asthma drug dispensation, hospitalisation or long-term disease for severe asthma, the researchers explained.
The specific definition omitted drug dispensation and the combined one considered the dispensations of specific asthma medications, hospitalisation or long-term disease for severe asthma.
Professor Demoly and colleagues said: ‘Of note, our results showed a greater reduction in younger patients which highlights the interest of starting AIT as early as possible.’
In patients with pre-existing asthma, the Global Initiative for Asthma (GINA) treatment step-up evolution was also analysed, with researchers finding SLIT-liquid exposure was associated with a one-third reduction in GINA step-up regardless of baseline treatment step.
‘Our findings support the long-term effectiveness of personalised SLIT-liquid in real-life for the treatment of [allergic rhinitis] patients with and without pre-existing asthma and substantiate its evidence as a relevant causal treatment option for patients with respiratory allergies, for all ages and allergens considered, with abilities to prevent both disease onset and progression,’ the researchers concluded.
This follows similar research from Germany in 2021, which found allergen immunotherapy for allergic rhinitis and/or asthma remained effective over a nine-year follow-up period.
Here at Hospital Healthcare Europe, we provide consultants and heads of hospital departments with inspirational examples of best practice, and that includes sharing insights into innovative projects being launched across the UK and Europe to support clinicians and improve patient care.
If you’re working on a new and exciting way to transform clinical practice and would like to share it with colleagues, we want to hear from you.
We’re looking for pilot projects, applied research and case studies covering all areas of professional expertise including:
To be considered for publication, you will need to submit an abstract of up to 100 words to secondary care content director Andrea Porter with the subject line: HHE article submission. This should briefly outline what your project set out to achieve, who and what was involved, as well as the top-line findings and/or impact on patient care.
Andrea will then get in touch to discuss possible next steps, including word counts, deadlines and any editorial and language support required.
All published works will be edited by Hospital Healthcare Europe’s in-house team before publication, with final approval from the secondary care team being showcased.
A recent example of a published project can be found here: Ceiling-mounted IR systems: facilitating same-day prostate artery embolisation.
And to read more about innovative projects being led by other members of the multidisciplinary team, visit Hospital Pharmacy Europe.
Get in touch today to share your latest project!
1st May 2024
Cholesterol-lowering drugs are less frequently prescribed to women compared to men, despite European Society of Cardiology (ESC) guidelines recommending statins for all patients with chronic coronary syndrome, new research has revealed.
Recommendations for target levels of low-density lipoprotein (LDL) cholesterol are the same for women and men, but previous studies have shown that women are less likely to meet these target levels.
This new retrospective observational study, presented at the recent ESC Preventive Cardiology 2024 congress, considered whether women and men actually receive the same treatments, as is outlined in ESC guidelines.
Electronic health records were used to obtain data on cholesterol levels of 1,037 men and 415 women with a chronic coronary syndrome diagnosed between 2012 and 2020, and who had never had a heart attack. The median age was 68 years in men and 70 years in women.
Information on dispensed medications was obtained from the Swedish National Prescribed Drug Registry and participants were followed up for three years following their diagnosis.
At the end of the third year of follow-up, just 54% of women were treated with cholesterol-lowering drugs compared with 74% of men. Additionally, 5% of women were treated with statin plus ezetimibe compared with 8% of men.
Dr Nina Johnston, study author and cardiologist at Uppsala University in Sweden, said: ‘Cholesterol-lowering drugs save lives and prevent heart attacks, and should be prescribed to all patients with coronary artery disease. Unfortunately, our study shows that women are missing out on these essential medications.
During the study, the researchers also examined treatments and cholesterol levels of women and men diagnosed with a chronic coronary syndrome at different ages: less than 60, 60-69.9, 70-79.9 and 80 years or older.
In all age groups, prescription of cholesterol-lowering treatment was found to be highest at diagnosis and declined over the following three years. This decline was steeper in women compared with men.
For example, in patients under 60 years of age, 65% of women and 79% of men were treated with cholesterol-lowering treatment the week after diagnosis, compared with 52% of women and 78% of men three years later. Achievement of LDL cholesterol targets was also lower in women than men.
Dr Johnston added: ‘Our findings should be a wake-up call about the undertreatment of women with heart disease. Equal prescribing practices are needed so that women receive all recommended therapies and are protected from adverse outcomes.’
The researchers are currently investigating factors which may explain the observed sex differences.
29th April 2024
Broadening his professional scope to make the biggest impact on patient care is what consultant rheumatologist Dr Benjamin Ellis has been striving to do since joining the profession. With roles at NHS England and the World Health Organization, as well as charity positions under his belt, he speaks to Saša Janković about what his diverse career has taught him, his passion for supporting patients with chronic pain and his hopes for the future of rheumatology.
Are you a hiker or a mountain climber? This is the question junior doctors and medical students are often left wondering after they speak to consultant rheumatologist Dr Benjamin Ellis about the path their career might take.
‘I say there are two sorts of careers you can have: one like a hiker who has a map and a route plotted, and one like a mountain climber, where all you can see on the cliff face is the next handhold,’ he says.
‘My career has always been more like the latter – I never know what’s coming but I look for the most interesting thing and I grab it and go for it.’
This approach has seen his patient-facing clinical work complemented by a whole host of additional roles within the NHS, UK charities and even the World Health Organization.
Why a career in medicine appealed in the first place is simple: ‘It was the coming together of two things I enjoyed, which was sciences and working with people, and it is infinitely exciting to work with people who are unwell or in pain to become partners in their healthcare.’
And it was this desire to build strong partnerships that led him to specialise in rheumatology, too. ‘I’d reached the conclusion that I wanted to do an outpatient-focused specialty and have patients that I would see for many years, and relationships felt very important, which left me with a small number of specialties,’ he explains.
A serendipitous phone call from a hospital he’d previously worked at saying there was an opening in rheumatology in two weeks’ time was the deciding factor. Was he free? Absolutely.
Since then, supporting patients living with chronic pain has become his passion and Dr Ellis works tirelessly to offer person-centred care and help to improve their quality of life.
‘The medicine is complex and fascinating. But supporting people who have previously been well and now have an illness and helping them to unpack it and reach a level of understanding where they can be in control of navigating the treatment choices over the long term is so important to me,’ he says.
‘There is something about the invisibility of chronic pain and the connection you can make with another person when you say, “I see you and I know that other people can’t see your pain and it’s invisible”, and then being able to support them to live more of the life they want to.’
With a strong desire to continue making a difference to as many people as possible, it wasn’t long before Dr Ellis was keen to expand his remit.
‘After two years as a rheumatology trainee I felt there was something more I wanted to do’, he says. ‘As an undergraduate I had loved courses in public health, and I heard that the then chief medical officer [for England], Liam Donaldson, was looking to recruit clinical advisors to work half the time at the Department of Health and the other half supporting the World Health Organization Patient Safety programme, which he chaired.’
Dr Ellis applied and got the role, taking a break from his clinical training to work on data analysis and develop presentations, which fostered a particularly useful and transferable skillset.
‘I learned a lot from Liam Donaldson. He taught me how to chair a meeting – a very useful skill – as well as how to bring together a working group, and management around policymaking’, he says. ‘I also wrote chapters for his annual reports, including one on chronic pain, which was actually the burgeoning of my interest in that topic and led me to do a master’s in public health, which I did in my own time at Johns Hopkins University.’
After two years in this dual role, a conversation with the medical director of the charity Arthritis Research UK – which would later become Versus Arthritis – revealed his next opportunity.
Putting his metaphorical crampons back on once again, Dr Ellis started a similar position as senior clinical policy advisor for the charity in 2010. Fitting in around the remainder of his medical training, this role opened up another avenue for him to follow his core passion of supporting people to live the life they want.
He was able to champion a public health approach to musculoskeletal health and improve the extent and quality of musculoskeletal health data. ‘I’m doing something where I am using the best of my energy and enthusiasm and making a little bit of difference’, Dr Ellis says of the role in which he remains to this day.
Broadcasting his community spirit ever wider, in 2010 Dr Ellis was a founding trustee of KeshetUK – an organisation aiming to ensure that Jewish LGBT+ people in the UK and their families are included in every aspect of Jewish life.
Now an education and training charity, which Dr Ellis chaired until 2022, KeshetUK works with schools, youth and young adult organisations, synagogues and others to champion ‘a vision of the world where no one is forced to choose between their Jewish and LGBT+ identity’.
Following on from this, at the start of 2024, Dr Ellis was named Member of the Order of the British Empire (MBE) in the New Year Honours list for services to healthcare, equality and the Jewish community.
‘It made me feel that the issues I really care about are being recognised,’ he says of the honour, ‘and that is a wonderful thing, because if the MBE opens doors and helps get more good work done, that’s great for everyone.’
Acknowledging his diverse career, Dr Ellis says he thinks it ‘absolutely makes such a difference’ for consultants to broaden their professional scope in order to extend their practice.
‘In England, very many of us have only worked in the NHS and you imagine the whole world runs like that,’ he says, ‘but I see friends in other industries and in the charity sector who think completely differently from people in the NHS, and I’ve learned a great deal from that cross-pollination.’
He adds: ‘The more experiences you have, you realise you can almost always solve things by bringing together good people and having a think, and that’s made me much more creative within the NHS.’
Back in the hospital, Dr Ellis spends two-and-a-half-days a week in clinic at Imperial College Healthcare NHS Trust ‘seeing a mixture of new and follow-up patients in rheumatology’. In 2022, handed over his role as head of speciality for rheumatology to take up the position of clinical director for outpatient transformation alongside his diverse set of responsibilities.
To this end, one day a week is spent working on strategies about ‘how we maximise the value of every outpatient encounter between the clinician and the outpatient’ – a particularly important task considering the immense pressure the NHS is currently under.
‘We’re looking at all our processes and procedures so that when clinicians come together with patients and carers it’s through the most seamless pathway for everyone,’ explains Dr Ellis.
Part of this includes the strengthening of the primary-secondary care interface, and it’s here, once again, that Dr Ellis looks to others for inspiration.
‘Patients we see for the first time almost always come through a referral from a primary care physician first before they see a specialist, but we know from systems in other countries that it doesn’t have to be that way,’ he says.
‘We want to support GPs to hold people in primary care without ever coming to see a specialist in the first place. We are making it easier for primary care physicians to approach us through electronic systems if they have questions about a patient’s test results, what else they should consider before referring or maybe not even referring at all.
‘We are also implementing online multidisciplinary meetings where primary care teams can discuss patients with specialists, which can improve holistic care while reducing unnecessary referrals.’
Dr Ellis says there are ‘big, big challenges’ in rheumatology despite good progress having been made in the field.
‘Although the range and effectiveness of treatments for autoimmune diseases have got much better compared even to 30 years ago, I still cannot tailor the treatment to the person, so it remains a sequential treatment path of trying one thing, then another, then the next until something – hopefully – works, and we need that to shift,’ he says.
The next hurdle he sees is the lack of treatments that can change the course of osteoarthritis. ‘While joint replacement can be very effective for those that need it, there’s a massive gap in medicines that can treat the pain of osteoarthritis and help people to enjoy a high-level quality of life,’ he says.
‘We need technologies now to be able to identify what is going on early in the course of the disease and then invent treatments that can change the outcome. Up to 50% of osteoarthritis may be preventable – so, as prevalence rises, we need a public health arthritis manifesto to tackle risk factors and prevent people getting the condition in the first place.’
And then there’s addressing the wider landscape of chronic pain. ‘There is huge prevalence of chronic pain, including back pain and conditions like fibromyalgia where the chronic pain is the condition itself,’ Dr Ellis explains. ‘We’re just beginning to unpick what some of this is, but there is still incredibly poor understanding of these conditions among the general public and clinicians. Recent research linking chronic pain to joint hypermobility and neurodiversity is fascinating, and we have so much more to learn, and, importantly, to communicate to the general public and those affected.’
How can this be achieved? ‘A frame shift within clinical provision as to how health services de-medicalise and support people with many of these chronic pain conditions, and a change in society about how we think about these conditions. Only when those two come together can we really make something happen,’ he says.
As for what the future holds for himself, Dr Ellis admits he doesn’t know what will come next – a classic answer from a clinician who has taken the uncharted mountain climbing route to their career. ‘I find that through making connections and being constantly curious about where I can contribute, something always comes up. Perhaps there’ll be somebody who reads this and says, “please come and talk”.’
Having already made an impressive contribution to rheumatology and beyond, and with a huge amount of potential in the field, not to mention his unrivalled drive to make a difference, it undoubtedly won’t be long until Dr Ellis’s next handhold comes into view and his climb will continue.
26th April 2024
Specific nasal cells found in children offer protection against Covid-19 infections and may explain why younger people typically experience milder Covid-19 symptoms than older adults, a new study has found.
Nasal epithelial cells, the primary target of SARS-CoV-2, were found to respond differently to the virus depending on a person’s age. Nasal epithelial cells collected from children quickly activated an antiviral response by increasing the production of interferons, leading to incomplete replication of the SARS-CoV-2 virus. Conversely, in older people, the antiviral response in the nasal cells was slower.
Published in the journal Nature Microbiology, the scientists from University College London (UCL) and the Wellcome Sanger Institute said the study could be ‘critical’ in developing antiviral treatment tailored to different age groups, underscoring the importance of age in both research and treatment of infectious diseases.
Despite effective vaccines, age remains the most significant risk factor for people infected with Covid-19. Research shows that infected children rarely progress to respiratory failure, whereas the risk of mortality for people over 85 years of age is as high as one in 10.
To analyse the differences in nasal epithelial cells and the behavioural responses associated with a Covid-19 infection across different age groups, the researchers recruited healthy volunteers from five large hospital sites in London between March 2020 and February 2021.
Clinicians obtained nasal brushings from participants, including children aged 0–11, adults aged 30–50, and older adults over 70. All donors tested negative for SARS-CoV-2 and had no respiratory symptoms in the preceding seven weeks.
After 28 days, the samples were infected with SARS-CoV-2 isolate hCoV-19/England/2/2020, obtained from the then Public Health England, and then incubated for 72 hours to encourage maximum viral replication.
Children were found to respond quickly to the SARS-CoV-2 virus. After three days, the paediatric cultures showed an increase in the signalling protein interferon, which can inhibit viral replication in infected cells. In cultures from older adults, the early antiviral effect became less pronounced with age.
The researchers also found increased virus production and more infectious viruses in the nasal epithelial cells of infected older adult cultures compared with paediatric cultures. Moreover, older adult samples showed increased cell shedding, thinning, leakiness and damage, which could be linked to the greater severity of disease observed in this age group.
Significant age-related differences were observed in the cellular composition of nasal epithelial cells. Single-cell RNA sequencing of 139,598 cells revealed 24 distinct epithelial cell types or states, including basal, secretory, and ciliated cells.
A higher abundance of basal cells was found in adult cultures compared to paediatric cultures, but the most notable difference between age groups was the increase in goblet cell types observed in paediatric cultures. The researchers suggest that the goblet cells may help restrict viral replication.
Co-senior author Dr Kerstin Meyer, a principal staff scientist in cellular genetics from the Wellcome Sanger Institute, said: ‘By carrying out SARS-CoV-2 infections of epithelial cells in vitro and studying the responses with single-cell sequencing, we get a much more detailed understanding of the viral infection kinetics and see big differences in the innate immune response between cell types.’
Taken together, the researchers say the findings highlight how the small changes in the cells of the upper airways can impact the development of SARS-CoV-2 infection across different age groups.
Project lead, Dr Claire Smith, associate professor at the UCL Great Ormond Street Institute of Child Health, said: ‘Our research reveals how the type of cells we have in our nose changes with age, and how this affects our ability to combat SARS-CoV-2 infection. This could be crucial in developing effective anti-viral treatments tailored to different age groups, especially for the elderly who are at higher risk of severe Covid-19.’
The researchers said that understanding the differences in nasal epithelial cells at the initiation of infection is just the beginning. They now aim to investigate the long-term implications of these cellular changes and test therapeutic interventions using their cell culture model.
In January, it was announced that 1.4 million more people in the UK, including a wider group of older adults, would be eligible for the antiviral treatment nirmatrelvir plus ritonavir (brand name Paxlovid) if they test positive for Covid-19.
A biomarker-based strategy is comparable to a magnetic resonance imaging (MRI)-enhanced approach for prostate cancer screening but results in more biopsies and increased detection of less aggressive cancers, a randomised trial has found.
Prostate cancer guidelines often recommended obtaining an MRI before a biopsy, yet MRI access was limited and using blood-based biomarkers with systematic biopsies could provide an alternative approach, Swedish researchers wrote in the journal JAMA Network Open.
In the open-label randomised trial, 12,743 men aged 50 to 74 with no previous cancer diagnosis underwent blood sampling for prostate specific antigen (PSA) levels and Stockholm3 tests to estimate their risk of clinically significant prostate cancer.
After the blood tests, men were randomly assigned in a 2:3 ratio to receive a Stockholm3 test with systematic biopsy (biomarker group) or a PSA test followed by MRI with systematic and targeted biopsy (MRI-enhanced group).
The Stockholm3 test, combines patient age, previous prostate biopsy results, family history of prostate cancer, single-nucleotide variations and levels of total PSA, free PSA, human kallikrein 2, β-microseminoprotein and growth differentiation factor 15 to estimate the risk of clinically significant cancer (Gleason score ≥ 3 + 4).
In the biomarker group (5,134 men), 8.0% of participants (413) had a Stockholm3 risk score of 0.15 or higher and underwent systematic biopsies, researchers said.
In the MRI-enhanced group (7,609 men), 12.2% participants (929) had a PSA level of 3ng/mL or higher and were referred for an MRI with biopsies if they had a Prostate Imaging-Reporting and Data System (PI-RADS) score of 3 or higher.
Detection rates of clinically significant prostate cancer were comparable between the two groups: 2.3% in the biomarker group and 2.5% in the MRI-enhanced group.
However, researchers reported more biopsies were performed in the biomarker group than in the MRI-enhanced group (326 of 5,134 [6.3%] vs 338 of 7,609 [4.4%]).
There were also more indolent cancers detected in the biomarker group (61 [1.2%] vs 41 [0.5%]).
Senior author Professor Anna Lantz, associate professor in urology at Karolinska Institute and consultant urologist at Karolinska University Hospital Solna in Stockholm, Sweden, noted that certain areas and healthcare systems lacked the capacity to implement the diagnostic chain required for MRI-based screening and the cost of MRI of the prostate varied by setting.
Given their findings, they concluded the Stockholm3 test could be a feasible alternative in regions with limited access to MRI.
‘Nevertheless, the biomarker-based approach comes at the expense of more biopsy procedures and increased detection of less aggressive cancers,’ Professor Lantz and colleagues said.
Strengths of the study included its randomised design, large-size and population-based screening setting.
Regarding limitations, the authors noted that optimal PSA cut-off values for triggering a Stockholm3 test and guiding biopsy decisions were undetermined.
‘Finally, we focused on detecting clinically significant prostate cancer, and long-term prostate cancer mortality implications remain uncertain,’ they wrote.
Last month, a Cancer Research UK study found fewer middle-aged people are dying of cancer in the UK than at any point over the last 25 years, despite a rise in cases of cancer, partly due to improvements in screening programmes.
Another recent artificial intelligence-based study found that prostate tumours evolve in two distinct disease types, which may lead to better diagnosis and tailored treatments in future.
An expanded guideline providing evidence-based recommendations for the management of adult and juvenile-onset Sjögren disease has been published by the British Society for Rheumatology (BSR).
Updated from the original 2017 version which focused on the systemic effects of the condition, the new guideline provides a framework for healthcare professionals to effectively and proactively manage individuals with Sjögren disease.
Its aim is to standardise care across the UK and enable non-specialist rheumatologists and allied healthcare professionals involved in the treatment of Sjögrens disease to manage patients holistically and in a personalised way.
The guideline working group established a set of 19 key questions around Sjögren disease diagnostics, comorbidities, clinically effective and timely treatments, considerations in pregnancy, non-pharmacological recommendations and tailored long-term follow-up.
They then interrogated the literature to determine the answers, which were then used to develop the recommendations.
For the first time, the guidelines include advice on Sjögren disease in adolescence and recurrent parotitis. They also note medication advancements such as access to ciclosporin for very severe eye dryness from four years of age and evidence around conventional and biologic disease-modifying antirheumatic drugs.
Dr Coziana Ciurtin, consultant in adult and adolescent rheumatology, said: ‘This is a first at an international level – there is no other guideline that looks at Sjögren disease across all ages. We recognise the need to incorporate recommendations for an under-diagnosed disease phenotype that starts in younger patients, who present slightly differently and may have different needs. We aim to support all clinicians and allied health professionals in diagnosing and looking after these younger patients.’
The guideline working group included members from rheumatology, including adult, adolescent and paediatric specialists, alongside a diverse working group consisting of GP, occupational therapy, ophthalmology, renal specialists and experts by experience.
As part of their work, the group took the decision to change the name of the condition from Sjögren syndrome to Sjögren disease. Dr Elizabeth Price, consultant rheumatologist at Great Western Hospital who led the BSR guideline development, said: ‘We had feedback from [European colleagues] and the patients that they preferred the name disease as it changed the emphasis of the condition and there is a move away from eponymous syndromes.’
She added: ‘I think in time we might lose the disease as well and it might just become Sjögren but we felt it was a little bit too early to do that.’
Alongside the full guideline, the working group have produced an easy-access summary sheet, which is free to download, as well as an audit tool that supports clinicians in making a correct diagnosis.
The BSR has recently extended the data capture for the New Early Inflammatory Arthritis Audit to include patients with newly diagnosed connective tissue disorders, including Sjögren’s.
Speaking at a roundtable on the guideline’s publication, Dr Price said: ‘A plea from me: if you can put all your newly diagnosed Sjögren’s patients into the audit, that will help us tremendously. Can I urge you to use the most modern criteria, which are referred to in the guideline as the ACR-EULAR combined 2016 criteria. If you look at the audit tool that goes along with the guideline, the first item in the audit tool is have you met the guidelines and there’s a little tick box for you to do that.’
25th April 2024
The cystic fibrosis (CF) medication ivacaftor (brand name Kalydeco) is safe and effective in infants aged four weeks and over, paving the way for earlier initiation of therapy for newborns diagnosed with the condition, a phase 3 open-label study has found.
Ivacaftor, a cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy, was originally approved for use in adults but has since been shown to be safe and efficacious in children as young as four months.
The therapy increases channel gating activity at the cell surface in patients with CTFR gating mutations. These mutations, which prevent chloride from moving in and out of cells, are thought to cause approximately 4% of CF cases worldwide.
The latest study involved the youngest cohort treated with any CTFR modulator to date, researchers reported in the Journal of Cystic Fibrosis, with infants aged from one month to less than four months old.
Seven infants with mean age at baseline of 1.9 months with CF and an ivacaftor-responsive CTFR variant were enrolled in the phase 3 open-label trial, receiving an initial low dose of ivacaftor based on age and weight.
‘Because ivacaftor is a sensitive CYP3A substrate and CYP3A maturation is uncertain in this age group, an innovative study design was developed wherein each infant initially received a low dose of ivacaftor that was subsequently adjusted based on individual pharmacokinetic results to ensure safe dosing,’ researchers wrote.
They observed a mean decrease in sweat chloride concentration of -40.3 mmol/L from baseline through Week 24, which was generally comparable to the decreases previously reported in children aged four months to less than six months (-50 mmol/L) and in children aged six months to less than 12 months (-58.6 mmol/L).
Infants also had improvements in pancreatic function, intestinal inflammation and growth parameters, according to the study, which was sponsored by the ivacaftor manufacturer Vertex Pharmaceuticals and conducted at four medical centres in the US and Ireland.
The researchers reported ivacaftor was generally safe and well tolerated, with all adverse events being mild in severity and non-serious and generally consistent with common manifestations of CF.
‘One infant discontinued ivacaftor due to an adverse event of elevated alanine aminotransferase/aspartate aminotransferase concentration more than eight times the upper limit of normal that was not considered by the site investigator to be related to be related to ivacaftor and occurred in the context of recurrent viral illnesses in the infant,’ they added.
‘Since pharmacokinetics were predictable, an ivacaftor dosing regimen in infants one to under four months of age based on weight and age is proposed.’
Lead author Professor Paul McNally, associate professor at the Royal College of Surgeons in Ireland and consultant in respiratory medicine at Children’s Health Ireland, said the study findings were a ‘huge moment’ in CF.
‘Over the years ivacaftor… has been put through clinical trials in younger and younger children. Now, through this study, it has been shown to be safe and effective all the way down to four weeks of age,’ Professor McNally said.
Almost all children were diagnosed through newborn screening at around this time, he noted.
‘The availability of a treatment that targets the underlying cause of the disease in newborns and can be started immediately at diagnosis will provide a huge sense of reassurance and hope for families,’ Professor McNally added.
Vertex Pharmaceuticals is applying to the European Medicines Agency for an extension to the marketing authorisation for ivacaftor to infants aged one month.
Last year the UK’s Medicines and Healthcare Products Regulatory Agency extended the licence of another CF medication ivacaftor-tezacaftor-elexacaftor (brand name Kaftrio) in combination with ivacaftor to include children aged two to five years old.
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