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Take a look at a selection of our recent media coverage:
26th July 2024
The interleukin (IL)-23 inhibitor risankizumab (brand name Skyrizi) has been granted marketing authorisation by the European Commission for ulcerative colitis.
The indication covers the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.
This marks the fourth approved indication for risankizumab after plaque psoriasis, psoriatic arthritis and Crohn’s disease.
Risankizumab selectively blocks IL-23 by binding to its p19 subunit. The recommended induction dose is 1,200 mg administered by intravenous infusion at Week 0, Week 4 and Week 8. Starting at Week 12 and every eight weeks thereafter, a recommended maintenance dose of either 180 mg or 360 mg administered by subcutaneous injection should be based on individual patient presentation.
‘Ulcerative colitis is a chronic, unpredictable and sometimes debilitating disease, and people living with the condition need sustained symptom relief,’ said Dr Edouard Louis, professor and head of gastroenterology at Liège University Hospital and dean of faculty at Liège University in Belgium. ‘This approval introduces a new treatment option to help patients with ulcerative colitis reach their long-term treatment goals.’
The EC approval of risankizumab is based on the results of two phase 3 clinical trials, INSPIRE and COMMAND, in which the primary endpoint was clinical remission. Secondary endpoints included mucosal healing and histologic endoscopic mucosal healing (HEMH).
In the INSPIRE induction trial, a significantly higher proportion of patients treated with risankizumab 1,200 mg IV achieved the primary endpoint of clinical remission (per Adapted Mayo Score) at Week 12 than patients receiving placebo (20% vs 6%; p<.00001).
Mucosal healing (defined as ES ≤1 without friability) was observed at Week 12 in 37% of patients treated with risankizumab 1,200 mg IV compared to 12% of those receiving placebo (p<.00001). In patients without previous biologic or JAK inhibitor failure, 48% of patients treated with risankizumab 1,200 mg IV achieved mucosal healing at Week 12 versus 14% of those receiving placebo.
Some 24% of patients treated with risankizumab 1,200 mg IV achieved HEMH (defined as Geboes score ≤3.1 and ES ≤1 without friability) at week 12 versus 8% of those receiving placebo (p<.00001).
In the COMMAND maintenance trial, a significantly higher proportion of patients who received risankizumab 180 mg or 360 mg SC achieved clinical remission at Week 52 than patients in the induction-only control group: 40% and 38%, respectively, versus 25% (p≤.01).
Some 51% of patients treated with risankizumab 180 mg and 48% of patients treated with 360 mg achieved mucosal healing at Week 52 versus 32% of patients in the induction-only control group (p<.001). In patients without previous biologic or JAK inhibitor failure, 60% of patients who received risankizumab 180 mg and 76% who received 360 mg achieved mucosal healing versus 36% of patients in the induction-only control group.
Some 43% of patients treated with risankizumab 180 mg and 42% receiving 360 mg achieved HEMH at Week 52 versus 23% in those treated with the induction dose only (p≤0.01).
Professor Louis, who was also a trial investigator, added: ‘Patients treated with Skyrizi in the INSPIRE and COMMAND clinical trials experienced significant improvements in clinical remission and mucosal healing. These are important findings as mucosal healing goes beyond symptom management to restoration of the intestinal lining and is associated with improved long-term outcomes.’
The safety profile of risankizumab in both trials was consistent with the safety profile observed in previous trials across other indications, with no new safety risks observed. The most common adverse events observed were Covid-19, anaemia, nasopharyngitis and arthralgia.
25th July 2024
A project aiming to improve the care of older people in emergency departments (EDs) in the UK has found ‘room for improvement’ nationally, the Royal College of Emergency Medicine (RCEM) has announced.
The ‘Care of Older People’ RCEM National Quality Improvement Programme – now in its second of three years – has compared the performance of 118 participating EDs against a set of RCEM standards of care for patients aged 75 and older.
Published in its Year 1 interim report, the results show a need for ‘room for improvement across the board, in all standards’, and highlight ‘the first areas where change should be taking place‘.
As such, the report includes recommendations for the second and third years of the project to enhance the experience and outcomes for older people receiving ED care and help to achieve the required standards.
Dr Adrian Boyle, President of RCEM said the project ‘provides a valuable opportunity to gain the first insights into the level of care being given to older and frail patients on a national level‘ and thanked the participating emergency departments for their collaboration.
A total of 9,155 Type 1 ED attendances for older patients meeting inclusion criteria for the National Quality Improvement Programme were included, with a Type 1 ED being defined as one that provides a 24-hour, consultant-led service with full resuscitation facilities.
The report captured a ‘baseline’ level of care of older people presenting with a Version 2 National Early Warning Score (NEWS2) of 4 or under from May 2023 to October 2023. It then measured the percentage of participating EDs that carried out a range of assessments including tests for delirium and risk of falls.
In relation to RCEM’s Standard 1, that all people aged 75 years and older in ED should be screened for delirium using the 4AT tool, assessed for falls risk, and screened for frailty, the results showed that 21.5% of patients (n=1997) were screened for delirium using any tool, and only 68.3% of these were screened using the 4AT tool.
As such, only 14.98% of patient care met the standard, while 31.7% failed to meet the standard because of the screening tool used.
A total of 43.79% of patients received the falls risk assessment and 53.06% of patients were screened using a recognised frailty scoring system.
Standard 2 requires that action is taken based on the findings of screening processes. This includes a delirium management plan, post-fall assessment, falls mitigation and comprehensive geriatric assessment (CGA) being initiated where appropriate.
The report revealed that of the patients found to have delirium (n=467), 28.76% had a complete delirium management plan initiated.
When it came to falls, 37.25% of patients presenting after a fall had a dedicated post-fall assessment, and 32.58% of patients identified as being at risk of falls had a full falls mitigation plan put in place.
On average, 35.5% of patients had a CGA initiated if indicated from their frailty score. The control limits showed that the process is relatively stable but unlikely to reach beyond 50% compliance unless there is a change in the system.
Standard 3 requires that patients should have their basic care needs met whilst in the ED via a safety round. The report found that 55.8% of all patients had an ED length of stay of more than six hours, and of these, 31.5% had a full safety round initiated.
Comprehensive training for all relevant ED staff was the most common recommendation outlined in the report, with education encompassing the identification of delirium, falls and frailty in patients, the tools that should be used to assess and screen patients and the next steps that should be taken being included.
Standardising care was also highlighted as a priority, with recommendations around developing clinical pathways, departmental policies and documentation protocols, as well as including alerts, prompts and mandatory fields on patient records to ensure screening is undertaken and appropriate next steps are widely understood and actioned.
The RCEM also noted organisational audit recommendations, including that all participating EDs should perform an organisational scorecard two to three times a year to review performance and make targeted plans for improvement.
It also flagged that pharmacists should be engaged in EDs to screen for polypharmacy and support prescribing for older people, and that concise discharge summaries should be available to give to patients.
Commenting on the report, project leader Dr Anu Mitra, consultant emergency physician at Imperial College Healthcare NHS Trust, said: ‘Older people constitute a cohort of emergency department patients which is growing in size, complexity and care needs and reflects a continuing demographic trend in all four nations.
‘As a specialty whose workload reflects issues in the wider health and social care landscape, emergency medicine must accordingly meet the challenges of caring for older people at the front door.
‘This national QIP has set a broad range of standards which cover both individual care and system design, to improve experience and outcomes for older people from the moment they enter the emergency department, using recognised quality improvement methodology and sharing of best practice.’
The RCEM said it plans to share this report widely with stakeholders within the immediate departments, and added: ‘As we embed this in our routine practice, we seek to get the support that EDs require to help them in their QI activities… If all teams share their thoughts and feedback, we would have a wealth of learning to share with each other and improve future programmes.’
The UK’s medicines regulator has approved the use of semaglutide (brand name Wegovy) for cardiovascular prevention in obese and overweight patients with established cardiovascular disease (CVD).
The Medicines and Healthcare products Regulatory Agency (MHRA) granted the authorisation on Tuesday this week, making it the first weight loss drug to be prescribed as a preventative treatment for cardiovascular events.
The drug, supplied by Novo Nordisk, is already approved and recommended by the National Institute for Health and Care Excellence for use as a treatment for obesity, alongside lifestyle changes and support.
It can now be used to reduce the risk of overweight and obese adults suffering events such as cardiovascular death, non-fatal heart attacks and non-fatal strokes, in people with established cardiovascular disease and a body mass index (BMI) higher or equal to 27 kg/m2.
The MHRA has granted this authorisation based on data from a clinical trial which found that semaglutide reduces the incidence of major adverse cardiovascular events (MACE) by 20% when compared with a placebo.
There were over 17,600 participants in the multi-national, double-blind trial who were randomly assigned either Wegovy or a placebo.
Novo Nordisk first revealed headline figures from this study a year ago, with full results since published in the New England Journal of Medicine.
At the time, the company said it expected to file for regulatory approvals for a label indication expansion of semaglutide 2.4mg during 2023.
MHRA deputy director of innovative medicines Shirley Hopper said the safety of Wegovy will be kept ‘under close review’ but that the MHRA is ‘assured that the appropriate regulatory standards of safety, quality and effectiveness for the approval of this medicine have been met.
‘This treatment option that prevents heart disease and strokes is an important step forward in tackling the serious health consequences of obesity.’
Professor John Wilding, professor in the department of cardiovascular medicine at the University of Liverpool, said the approval is ‘good news’ based on evidence from the trial.
He said: ‘Semaglutide is already approved for treatment of obesity, but despite a favourable NICE appraisal since 2023, many people living with obesity in England and Wales are still unable to access this treatment due to funding restrictions and limited availability of NHS services for the treatment of obesity.
‘It is hoped that this new widened indication will help funders of services to understand the benefits of treatment for people living with obesity, and provide appropriate support for clinical services to provide treatment.’
Dr Martin White, associate professor in metabolic medicine at the University of Surrey, said that data from the trial also showed that there was ‘no difference in cardiovascular outcomes in those who did or did not achieve 5% weight loss’ after 20 weeks of semaglutide.
‘This hints that weight loss per se may not be a crucial factor, but any benefit may instead relate to benefits on blood pressure, glucose and body inflammation,’ he suggested.
Semaglutide, which is a GLP-1 receptor agonist, was launched on the NHS as a weight-loss drug in September.
The drug is available via specialist NHS weight management services for people who meet NICE criteria, or privately through a registered healthcare professional, but has been in short supply due to global demand.
A recent study indicated that weight loss in patients on semaglutide can be sustained for up to four years and that the drug can cut CVD risk.
And further research has shown that semaglutide could be beneficial in helping to treat patients with type 2 diabetes and obesity-related heart failure.
A version of this article was originally published by our sister publication Pulse.
24th July 2024
Improving working conditions and introducing incentives in four key areas have been suggested as ways to retain healthcare professionals in hospitals, according to the EU-funded METEOR Project.
Published in the journal Qualitative Health Research, the findings highlight professional and personal support, education, financial incentives and regulatory measures as the main factors that healthcare organisations should focus on to retain their staff, in addition to improving working conditions.
The study involved a series of eight online co-creation workshops and four Delphi sessions surveying nurses and clinicians at eight European hospitals in four countries: Belgium, the Netherlands, Italy and Poland.
A thematic analysis was conducted, resulting in multiple interventions that were clustered into the four pre-defined themes.
Interviewees in all four countries emphasised the importance of leadership training, interdisciplinary teamwork and support for the non-clinical workload as key factors that could improve their working conditions.
Anke Boone, a researcher at the Centre for Environment and Health at KU Leuven and a co-author of the METEOR study, said: ‘In our workshops, healthcare professionals told us that personal support is key to enhancing job satisfaction. It also creates resilience against workplace stressors, mainly by knitting teams together more strongly.’
The professional and personal support interventions highlighted in the study to retain staff included regular interprofessional team meetings, leadership training programs, self-scheduling and sabbaticals, support for administrative and non-clinical work, and the provision of psychological counselling.
When it came to education, interviewees from all countries stressed the need for continuous professional development opportunities, including onboarding and mentorship programmes. They also advocated for a hospital-based development budget, allocated to each employee, as part of a comprehensive personal development plan.
Financial incentives included the provision of competitive salaries, adequate spending on infrastructure, extra benefits such as secure, permanent employment contracts.
However, as Olivia Lavreysen, a researcher at the Centre for Environment and Health at KU Leuven and a co-author of the METEOR study, pointed out, ‘many healthcare professionals say they’re willing to take a pay cut if it would mean an improvement in their current working conditions. That clearly shows that job quality and the level of support from healthcare organisations is more important than money.’
Desired regulatory measures addressed the need for harmonised legislation spanning local, national and international levels, fixed healthcare worker-to-patient ratios, and effective workload monitoring tools.
Interviewees hoped that such measures would alleviate workload pressures, support retention and ensure sustainable staffing levels, which are crucial for mitigating burnout and fostering professional satisfaction.
The authors concluded that while there is no one-size-fits-all approach to workforce retention, tailoring these interventions to address pressures within an organisation is encouraged.
Co-author Lode Godderis, professor at the Centre for Environment and Health at KU Leuven, added: ‘Healthcare providers need to look closely into their organisations and listen to employees to address their needs.’
Earlier METEOR findings revealed that 9% of doctors and nearly 14% of nurses intend to leave their professions, citing low job satisfaction, growing depersonalisation and emotional exhaustion as primary factors.
Jason Ali is a consultant cardiothoracic surgeon at Royal Papworth Hospital and the surgical clinical lead for the hospital’s new ‘Enhanced Recovery Unit’. Together with consultant intensivist Dr Mike Hoy and lead nurses Michelle Barfoot and Jonee Doronila, he has overseen the development and implementation of this new initiative aimed at improving the flow and experience of cardiac surgical patients in the early postoperative period.
Royal Papworth Hospital in Cambridge, UK, has a highly specialised intensive care unit (ITU) with many competing demands. In addition to cardiac surgery, there are patients requiring cardiothoracic transplant and mechanical circulatory support, respiratory extracorporeal membrane oxygenation (ECMO) and various cardiology procedures.
We have recently had challenges with cardiac surgical operations being cancelled due to a lack of ITU capacity, which needed resolving. The cardiothoracic surgery ‘Getting It Right First Time’ (GIRFT) report recommended ‘ring-fencing’ intensive care beds for cardiac surgery as a means of improving throughput and reducing cancellations.
The Enhanced Recovery Unit (ERU) was developed with this in mind – both offering the ability to ring-fence ITU beds for cardiac surgery and an opportunity for quality improvement by looking to enhance patients early postoperative recovery. It was hoped that this would improve the flow of cardiac surgical patients through the ITU – and the hospital – which should allow the team to limit cancellations and reduce waiting lists.
The ERU has been created as a new, standalone unit occupying a section of our original ITU. It has been established as a new business unit within the Trust, with separate clinical governance processes and directorate accountability.
The ERU model is a short-stay level 3 (intensive care) unit, with a maximum length of stay of 48 hours to maximise patient flow. If patients require ongoing level 3 care beyond 48 hours, they will be transferred to our adjacent ITU for ongoing management.
We are proud that the ERU is nurse-led. The unit leadership structure comprises two lead nurses, Michelle Barfoot and Jonee Doronila, with support from a dedicated lead intensivist Dr Mike Hoy and myself as lead surgeon.
On each shift there is a ‘cardiac surgical specialist’ nurse, who is a band 6 or 7, and has undergone specific training and ongoing assessment in managing immediate post cardiac surgical patients. They lead a team of bedside nurses, managing postoperative patients, with the aim of early extubation and early mobilisation – key components of enhancing recovery.
They are trained to manage common problems encountered in this patient population and are supported by surgical and anaesthetic doctors. Their aim is to have all patients sitting in their chair eating breakfast by the first post-operative morning, preferably drain free, ready to be transferred to our surgical ward.
We currently have only five beds in the ERU. To maintain patient flow, we are restricting admission to cardiac surgical patients who we predict will be admitted for less than 24 hours based on complexity of their surgery and how unwell the patient is preoperatively. Patients who are unlikely to be discharged within 24 hours, or who will require more advanced organ support, continue to be admitted to our ITU.
In time, we aim to expand the number of beds, and this will allow for relaxing of our selection criteria to those likely to require admission for less than 48 hours, meaning that a greater proportion of our surgical patients can benefit from the enhanced immediate postoperative care offered by our unit.
We hope that implementation of the ERU will improve our patients’ experience and lead to a reduction in the length of our waiting lists. We anticipate this will be achieved by reducing the length of stay of our surgical patients and by improving patient flow through the hospital, which will reduce cancellations.
We also see that there are significant benefits for our nursing staff, and we are confident that the ERU will have a really positive impact on nursing recruitment and retention. This is because the nurse-led nature of the ERU offers excellent opportunities for nursing staff progression and empowerment. There will be ample opportunities for learning and development with promotion into cardiac surgical specialist roles.
We hope that the smaller ERU team will allow for enhanced support of our nursing staff, offering a greater sense of belonging and improving staff wellbeing and morale.
Implementation of the ERU has been a great success so far. There is widespread recognition throughout the hospital of the positive impact the unit has been having on patient flow. In the first four weeks of opening, we admitted 101 patients, with 89% being transferred to the surgical ward within 48 hours.
It is not unusual to walk through the unit first thing in the morning and see all five patients sitting in their chair eating breakfast, which is an excellent achievement, and a major advancement on the care we were providing our postoperative patients previously. As a result, the feedback from surgeons and the patients has been very good.
There is a real sense of positivity in the unit from the nursing team, who are proud of the work they are doing and these early achievements. The unit is evolving, but so far so good.
Cardiac centres in the UK vary a lot in their practice. Unlike Royal Papworth Hospital, which is a dedicated tertiary cardiothoracic centre, some hospitals share critical care units with other surgical specialties, which brings its own challenges. There are cardiac centres in the UK that have recovery units and others that have high-dependency units for the early postoperative management of cardiac surgical patients. We are not aware if these have a similar nurse-led model for the care provided in these units.
Although it is early days in our experience, the positive impact of the ERU has already been felt – both with patient flow and with morale of the nurses working in the unit. We would strongly recommend other cardiac surgical centres to consider the nurse-led model for early postoperative management of cardiac surgical patients, especially as the unit offers the opportunity to truly ring-fence beds from competing demands.
The success of our implementation came from early collaboration between intensive care physicians, surgeons and senior nurses working together with hospital management to design the unit and define the protocol to be followed when managing patients.
We hope that the ERU will allow us to reduce our waiting lists for cardiac surgery at Royal Papworth Hospital, which have been growing in recent years since the Covid-19 pandemic. We believe that streamlining the immediate postoperative recovery of patients will have a positive impact and improve their experience.
We anticipate that the ERU is just the start of a larger project looking to enhance patients’ recovery following cardiac surgery at our centre and we will be reviewing each step of a patient’s journey, looking to implement changes that promote enhanced recovery.
With time, we are planning on expanding the unit to 10 beds, which will allow for the desired relaxing of the patient selection criteria. Expanding slowly will allow appropriate time for the confidence and expertise of the team to develop, which is important in building a successful department.
We hope that this will ultimately allow us to expand the number of operations we do a year, allowing us to maintain our position as one of the largest cardiothoracic centres in the UK.
22nd July 2024
The primary-secondary care interface is not effective at ensuring efficient continuity of patient care between settings, a new survey has found.
The State of Primary Care survey was undertaken earlier this year across Hospital Healthcare Europe and its sister titles. The respondents consisted of 1,795 NHS healthcare professionals, 1,294 of whom worked in primary care and 292 worked in secondary care in England.
It found that only 15% of respondents thought the primary-secondary care interface was effective at ensuring continuity, with 52% saying it was not effective.
Around 17% also said that primary care networks (PCNs) had improved collaboration between primary and secondary care, but 59% said they disagreed with this.
Most respondents (68%) added that they would like to see an improvement in the movement of patients between primary and secondary care prioritised by the next Government.
In June, NHS England asked ICBs to act as ‘referees’ to resolve ‘tension’ between primary and secondary care around workload and referrals.
NHS England‘s deputy medical director, Dr Kiren Collison, said there was ‘a lot of tension at times’ between primary and secondary care and that NHS England was trying to ‘get away from that’.
NHS Confederation recently said that there were four ‘key ingredients’ needed to ‘shift the dial’ in relationships between primary and secondary care. These were better understanding, shared information, improving communication methods and shared robust guidelines.
In April, NHS England‘s ‘2024/25 priorities and operational planning guidance‘ said that every hospital trust will be required to have a designated lead for the primary-secondary care interface.
And last year, the Academy of Medical Royal Colleges also set out 10 administrative changes that could be made to improve the way in which hospital and general practice staff work together. This included establishing regular ‘interface groups’, a primary care liaison officer, shared mailboxes and non-public phone numbers.
The State of Primary Care survey took place between April 29 and May 20 2024 across Hospital Healthcare Europe, Hospital Pharmacy Europe and our primary care sister titles Healthcare Leader, Pulse PCN, Pulse, Nursing in Practice, The Pharmacist and Management in Practice.
There were 1,795 responses from healthcare professionals. The majority of respondents, totalling 1,294 (72%), work in primary care in England. A further 292 (16%) work in secondary care in England. In addition, 124 (7%) work in primary or secondary care outside of England and 85 (5%) do not work in primary or secondary care. There were answers from across England with all 42 ICBs represented.
A version of this article was originally published by our sister publication Healthcare Leader.
A toolkit has been launched by the Royal College of Physicians (RCP) suggesting a range of everyday steps physicians can take to help the NHS reach its net zero goal and mitigate the risks of climate change.
The Green Physician Toolkit also brings together the evidence showing the impact of climate change on health, in order to educate and raise awareness of the issue among physicians. Case studies from across the NHS showcase how physicians can adopt these actions into their day-to-day practice.
‘Changes to clinical practice and how care is delivered, whether large or small, will make an important contribution to reducing the environmental impact of the health service‘, the RCP said.
The measures suggested by the RCP that physicians can take to help mitigate and adapt to the impacts of climate change include:
The NHS is responsible for around 40% of the UK’s public sector emissions and 4% of total emissions and the health service in England has committed to reaching net zero on all direct emissions by 2040.
The RCP said that all physicians have a vital role to play in helping the NHS reach this goal – and that changes to clinical practice and how care is delivered, whether large or small, will contribute to reducing the environmental impact of the health service.
It added that supporting patients to understand how climate change will affect their health is particularly important for older patients, young children, pregnant women and those with long-term health conditions like cardiovascular diseases and asthma.
Professor Ramesh Arasaradnam, RCP academic vice president, said: ‘Those working in the NHS will be some of the first to see the health effects of climate change, if they have not done so already. The need to act has never been more urgent and we hope that our Green Physician Toolkit will support the physician community with small steps that can make a difference.
‘It can of course be challenging to prioritise sustainability at a time when there is very high demand for clinical care, but we have to keep in mind that reducing climate change and its health impacts is part of reduced pressure on the NHS in the long-term.’
RCP special adviser on sustainability and consultant nephrologist, Dr Mark Harber, reiterated this point and added: ‘The priority for NHS staff will always be giving patients the best possible care – especially in the current context of high pressure and growing waiting lists. But the health impacts of climate change are increasingly visible, and as healthcare professionals, it would be irresponsible to ignore the increasing impact that climate change will have on patient health. It is important to support patients in mitigating the risk to their health.’
Earlier this year, a sustainability project aiming to reduce the waste being incinerated in operating theatres by 215kg a year was launched by University College London Hospitals NHS Foundation Trust, along with an initiative to replace single-use hats with named reusable fabric hats for staff working in operating theatres.
19th July 2024
The AKT inhibitor capivasertib (brand name Truqap) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for treating eligible patients with advanced breast cancer.
Capivasertib is indicated in combination with the hormone therapy fulvestrant for treating advanced hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced breast cancer with specific biomarker alterations (PIK3CA, AKT1 or PTEN) following recurrence or progression on or after an endocrine-based regimen.
This follows the marketing authorisation of capivasertib by the European Commission (EC) in June 2024 for the same indication.
The first-in-class drug is taken orally at a starting dose of 400 mg twice a day for four days followed by three days of rest, then repeated.
The MHRA and EC approvals were based on the results of the phase 3, randomised, double-blind CAPItello-291 trial, which included 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer. Of these, 289 patients (40.8%) had AKT pathway alterations.
Patients were randomised to receive either capivasertib or a placebo, both in combination with fulvestrant. The dual primary endpoint was investigator-assessed progression-free survival assessed both in the overall population and among patients with AKT pathway–altered (PIK3CA, AKT1, or PTEN) tumours.
In the overall population, the median progression-free survival was 7.2 months in the capivasertib–fulvestrant group, as compared with 3.6 months in the placebo–fulvestrant group (HR 0.60; 95% CI, 0.51 to 0.71; P<0.001).
In the AKT pathway–altered population, the median progression-free survival was 7.3 months in the capivasertib–fulvestrant group, as compared with 3.1 months in the placebo–fulvestrant group (HR 0.50; 95% CI, 0.38 to 0.65; P<0.001).
Potential side effects of capivasertib included high blood sugar, diarrhoea, rash and other skin drug reactions, urinary tract infection, low level of haemoglobin in blood, loss of appetite, nausea, vomiting, mouth sores or ulcers with gum inflammation, itching, and tiredness.
The most frequent adverse events of grade 3 or higher in patients receiving capivasertib–fulvestrant were rash (12.1% vs in 0.3% of those receiving placebo–fulvestrant) and diarrhoea (9.3% vs 0.3%).
Adverse events leading to discontinuation were reported in 13.0% of the patients receiving capivasertib and in 2.3% of those receiving placebo.
Professor Nicholas Turner, professor of molecular oncology at The Institute of Cancer Research, London, and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, who led the CAPItello-291 trial, said the MHRA approval is ‘wonderful development in the treatment of the most common type of advanced breast cancer’.
He added: ‘Around half of patients with this kind of breast cancer have mutations in one or more of the genes PIK3CA, AKT1 or PTEN, and for these patients, capivasertib provides an exciting, new targeted treatment which can keep their cancer from progressing for longer.
‘We hope NICE will recommend the use of capivasertib in combination with fulvestrant for patients on the NHS.’
Speaking about the EC marketing authorisation of this AKT inhibitor, Dr Mafalda Oliveira, senior clinical investigator of the Vall d’Hebron Institute of Oncology’s Breast Cancer Group in Barcelona, Spain, said: ‘Patients with advanced [HR]-positive breast cancer typically experience tumour progression or resistance with widely used endocrine-based treatment regimens, and there is an urgent need to provide them more time with their disease under control.
‘[This] approval is welcome news for approximately half of [HR]-positive breast cancer patients in Europe who have tumours with these biomarkers, and it is important for clinicians to test and identify eligible patients who may be able to benefit from this combination.’
Hospital Healthcare Europe (HHE) is delighted to welcome consultant cardiologist Dr Rebecca Dobson as a speaker on cardio-oncology at the upcoming Clinical Excellence in Cardiovascular Care event on 1 October 2024.
Dr Dobson specialises in imaging and cardio-oncology at Liverpool Heart and Chest Hospital and the Clatterbridge Cancer Centre. She will consider the impact of systemic anti-cancer therapy on the cardiovascular system, assessing cardiovascular risk and why it’s important, plus collaborative care and coordination of the multidisciplinary team (MDT) in cardio-oncology.
This session follows on from her contribution to the previous Clinical Excellence in Cardiovascular Care event in March 2024 in which she discussed the need and demand for cardio-oncology services, how they’ve developed over time and the current state of play in this evolving field, as well as providing an overview of cardio-toxicity.
Find out more about the upcoming Clinical Excellence in Cardiovascular Care event and register for free to hear the latest from Dr Dobson on cardio-oncology.
This latest event in HHE’s Clinical Excellence series brings together renowned experts from recognised Centres of Excellence and other key institutions to share best practice and explore the latest advances in cardiovascular care from prevention and inherited conditions to cardio-oncology and interventional cardiology.
Providing the opportunity to gain CPD hours, the day-long event will also focus on how to best use multidisciplinary teams and improve patient care in this area. The agenda has been created by HHE with guidance from industry experts to offer cardiologists and members of the wider MDT a comprehensive overview of this broad clinical area.
Registration is also open for the next Clinical Excellence in Respiratory Care event, which will take place on 21 November 2024.
To coincide with these two events, a whole host of additional content and interviews with prominent clinicians from Centres of Excellence and beyond have been published on the HHE website – look out for the orange Clinical Excellence tag in the Cardiovascular and Respiratory zones.
This includes a summary of a fascinating panel discussion on diagnostic imaging for respiratory conditions, with contributions from Dr Zaheer Mangera is a respiratory consultant and lung cancer lead at North Middlesex University Hospital NHS Trust.
Further events in HHE’s Clinical Excellence series will be announced soon, including new clinical areas, so watch this space.
The UK is set to become the first country in the world to have a national vaccination programme to protect both newborns and older adults against respiratory syncytial virus (RSV).
The vaccination rollout – which will start from 1 September 2024 in England, Wales and Northern Ireland, and from 12 August 2024 in Scotland – includes a vaccine for pregnant women over 28 weeks to help protect their newborn babies, and a routine programme for those aged over 75, which includes a one-off campaign for people aged 75 to 79.
These are the groups at the greatest risk from RSV, based on advice from the Joint Committee on Vaccination and Immunisation (JCVI) from June 2023.
The vaccination programme announcement follows the publication of an open letter in March 2024 signed by over 2,000 paediatricians and healthcare professionals from around the UK calling on the Government to act on the JCVI advice as soon as possible.
Commenting on the latest announcement, Dr Mike McKean, vice president for policy at the Royal College of Paediatrics and Child Health, which led the campaign, said: ‘We’re delighted that the calls of thousands of paediatricians and health professionals for a much-needed RSV programme have been heard. Campaigning for an RSV vaccine has been a key issue for the College for many years now and today’s announcement represents a huge step forward for child health and the paediatric workforce in England and Scotland.’
All adults turning 75 years of age on or after 1 September 2024 will be eligible for the routine programme and should be offered a single dose of the RSV vaccine on or after their 75th birthday.
A one-off catch-up campaign for those aged 75 to 79 years old as of 1 September 2024 will aim to complete the majority by 31 August 2025.
In line with JCVI guidance, individuals will remain eligible until the day before their 80th birthday, with the exception of people who turn 80 in the first year who have until 31 August 2025 to get vaccinated.
All women who are at least 28 weeks pregnant on 1 September 2024, will be offered a single dose of the RSV vaccine. After that, pregnant women will become eligible as they reach 28 weeks gestation and remain eligible up to birth.
Maternal RSV vaccination reduces the risk of the virus leading to severe bronchiolitis by 70% in the first six months of life, after which the risk of severe infection is much lower.
The UK’s RSV vaccination programme will use the same vaccine to protect both newborns and older adults against RSV, which is Pfizer’s bivalent recombinant vaccine called Abrysvo, was licensed by the Medicines and Healthcare products Regulatory Agency in November last year.
In one trial published in the New England Journal of Medicine, the Pfizer RSV vaccine given during pregnancy was shown to be effective against severe RSV-associated lower respiratory tract illness in infants up to six months old.
A second trial showed the vaccine prevented RSV-associated lower respiratory tract illness and RSV-associated acute respiratory illness in adults over 60 years of age.
NHS England data show RSV accounts for around 33,000 NHS hospitalisations in children aged under five in the UK each year, and is responsible for 20-30 infant deaths, posing a significant challenge to child health services each winter. It also causes around 9,000 hospital admissions in those aged over 75.
It is hoped the new vaccination programme will mitigate these risks, free up thousands of hospital bed days and help avoid hundreds of deaths each year.
Minister for public health and prevention, Andrew Gwynne, said he had seen the devastating effects of RSV firsthand.
‘My own grandson contracted RSV when he was just days old, leading to weeks in intensive care and a lifelong impact on his health. I don’t want anyone to go through what he went through.
‘Not only will this vaccine save lives and protect the most vulnerable, it will help ease pressure on our broken NHS, freeing up thousands of hospital beds as we head into winter.’
Dr McKean, added: ‘This newly announced programme has the potential to transform child health services during the winter months by reducing hospital admissions and could even save young lives. A reduction in RSV cases annually would allow us to focus on the many other children and young people requiring emergency care over winter months.
‘Vaccinations play a crucial role in protecting child health, but we are seeing a worrying decline in uptake across many routine childhood immunisations. As paediatricians, we want to continue to champion the use of vaccinations to win the battle against these dangerous and preventable infections.’
Dr Adrian Boyle, president of the Royal College of Emergency Medicine also welcomed the announcement, saying: ‘We greatly welcome the introduction of a national RSV vaccination programme to reduce the risk to children and ease the spike in seasonal pressure experienced by already overstretched [Emergency] Departments.
‘RSV is a nasty and potentially very serious illness which each year sees tens of thousands of poorly children brought into Emergency Departments by worried parents.
‘We commend the excellent work done by the Royal College of Paediatrics and Child Health in calling for the implementation of this vaccination programme and we look forward to seeing the positive impact felt by families and medical staff in the coming winter as a result.’
Dr Christopher Johnson, head of vaccine preventable disease programme at Public Health Wales said: ‘The RSV vaccine has the potential to save 1,000 young children every year in Wales from hospitalisation and could save the lives of over 125 older people each year.
‘It is a game-changing new vaccination programme that will protect thousands of our most vulnerable from getting ill in the first place, or significantly reducing the likelihood of severe infection, keeping people out of hospital and from needing to see a GP, and enabling more people to benefit from NHS services.’
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