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Press Releases

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

Next generation Proxima™ launched – delivering bedside blood gas and glucose analysis

16th December 2016

Sphere Medical, an innovative company in critical care monitoring and diagnostics equipment, has launched its next generation CE-marked Proxima™ system.

This unique bedside blood gas analyser (BGA) incorporates a new design and an extended analyte panel. Parameters now added to the new system include glucose and calculated parameters, such as P/F ratio and temperature corrected gases. The ability to monitor blood gases and measure blood glucose frequently and easily, directly by the patient, can enable earlier interventions and closer patient management, which is vital in fast changing critical situations.

As a patient dedicated system, Proxima is always connected to the patient via their arterial line and ready to go instantly. Since results are also delivered without the caregiver leaving the patient’s bedside, this significantly reduces time to result compared to conventional benchtop analysers. Its novel design means the system can travel with the patient on their pathway through the hospital. This is possible since the Proxima sensor contains an array of proven biosensor technology on a silicon chip, each a miniaturised version of the electrochemical sensors used in a traditional blood gas analyser.

In addition to the sensor, the next generation Proxima system includes a medical grade tablet monitor with an intuitive touchscreen user interface. All results are reported to the monitor and seamlessly transferred directly into laboratory information systems and electronic patient records. This is a key requirement for the successful implementation of point-of-care (POC) testing.

As an ex-vivo analyser operating as a closed system, blood is drawn directly from the patient and over the Proxima sensor. Following analysis, all blood is returned to the patient, meaning that there is no blood loss and risk of iatrogenic anaemia is reduced. Furthermore, infection risk to staff and patients is minimised as the arterial line remains closed throughout sampling. The design of Proxima also reduces pre-analytical errors due to the delivery of a high integrity blood sample direct to the sensor for immediate analysis with no mixing or anti-coagulant required.

The addition of glucose to the new Proxima’s analyte panel is significant as glucose measurements play a key part in the care of critically ill patients. Both hyperglycaemia and hypoglycaemia are associated with increased morbidity and mortality in intensive care unit (ICU) patients. Keeping patients in normal glycaemic range is difficult with current systems. The ability to regularly monitor arterial blood glucose using Proxima will support closer clinical management for improved glycaemic control.

Proxima is already redefining how arterial blood gas testing is carried out in critically ill patients through its use for the close monitoring of patients in the UK, Germany and Belgium,” said Dr Wolfgang Rencken, Chief Executive Officer, Sphere Medical. “Based on clinical feedback, we have launched our next generation Proxima which is now even better placed to support rapid and frequent measurements of blood gases, electrolytes and metabolites without blood loss. The addition of glucose to the analyte panel is the most significant new parameter, enabling better glycaemic control in the critically ill.”

Professor of Anaesthesia and Intensive Care Medicine, Mike Grocott, University of Southampton, also commented, “The recent time and motion study we conducted at University Hospital Southampton clearly highlighted the workflow benefits of using Proxima on critically ill, unstable patients. We look forward to the launch of the new Proxima and the opportunity to use this device on a larger patient group within the ICU.”

For more information on the new Proxima™ in-line blood gas analyser, please view www.spheremedical.com 

Beckman Coulter announces DxN VERIS Molecular Diagnostics and MicroScan Microbiology systems

12th December 2016

Beckman Coulter has launched two automated systems in the UK to ease rapidly increasing workloads in microbiology and virology departments. The DxN VERIS Molecular Diagnostics system, for same-day molecular viral load testing, and the MicroScan Microbiology Systems for microorganism identification (ID) and antimicrobial susceptibility testing (AST), both rapidly and accurately identify therapeutic pathways for patient management. This high-throughput testing significantly streamlines laboratory workflows, and reduces time to patient therapy diagnoses. The launch marks the advent of a significant investment in the UK microbiology market by Beckman Coulter with further product introductions scheduled.

The UK launch of the systems was celebrated with a showcase event – the first in a new series of educational events designed to provide a platform for interested parties to learn about new technologies. At the initial event, attendees had the opportunity to; speak to individuals using the new automated platforms, evaluate data in the form of presentations, and speak with technical experts to answer queries and gain a greater depth of understanding.

Duncan Whittaker, Laboratory Manager Virology at the Sheffield Teaching Hospital NHS Trust, spoke at the event about his experience with the DxN VERIS – which provides fast and accurate viral load assays by consolidating extraction, amplification and detection onto a single platform. “The DxN VERIS is the kind of instrumentation that will help the laboratory to meet long terms goals for improved services with faster turnaround times and greater productivity,” he commented. The easy-to-use DxN VERIS system saves both hands-on time and space in the laboratory. Results are available rapidly – facilitating fast decision making and positively impacting patient treatment. Duncan confirmed, “Training staff is very quick and straightforward, taking just 20 minutes. Initial comments have been that faster results for certain viral load assays could be life-saving in some instances.”

Attendees also heard from Michael Dawson, Senior Biomedical Scientist, from the William Harvey Hospital where two MicroScan WalkAway 96 Plus systems are in use as part of the East Kent Microbiology Service. The systems have improved workflow and streamlined processesthrough the rapid delivery of ID and AST with gold-standard accuracy. The easy-to-use walkaway systems allow simultaneous processing of conventional, rapid, and specialty panels. In addition, the MicroScan offers true Minimum Inhibitory Concentration (MIC) technology with visual read capability, which enables the detection of emerging resistance in real-time, without reliance on historical data.

Michael spoke about his Trust’s decision to move to the MicroScan platform for AST in particular. “For us the need to move to an automated microbial screening system was clear. Our previous multipoint testing methods, supported by disc diffusion testing, were non-reproducible, unreliable and inaccurate. In addition to the lack of standardisation, they were time consuming and whilst we screened for many agents, MIC determination required a further manual method.”

He went on to describe his experience of the MicroScan platform. “Time and accuracy are important factors for us as we screen over 160 isolates a day, seven days a week. We’ve found that the accuracy and reliability of MicroScan means that fewer isolates need further testing, reducing unnecessary manual work and delivering results in a predictable and consistent timeframe. We are particularly impressed with the quick and very easy-to-use standardised PROMPT inoculation system and the fact that the MicroScan has the fewest clinically significant limitations in regard to antibiotic and micro-organism combinations.” He expanded, “This is great as fewer limitations mean we don’t have to revert to a manual method – which lengthens the process and delays the final results for the patient. Also, we’ve found the LabPro software to be very user friendly. There’s an excellent rules database which is flexible and allows us to tailor the final interpretation to our requirements. In particular, the Alert Rules and comments are helpful as they provide a failsafe mechanism when validating results and reporting.  We are now looking forward to upgrading to the HighFlexX middleware solution which will allow us to integrate reporting from our MicroScan systems and MADLI-TOF, which is now used for ID requirements.”

When asked about his experience with Beckman Coulter, Michael Dawson said, “Beckman Coulter have a really enthusiastic, motivated and focused team working with us. They are attentive, listening to our concerns, and are responsive to our needs.”

Flexible access control with a proven track record in the health care sector

Flexible, scalable, affordable, wireless access control with a wealth of experience protecting patients, medicines, expensive equipment and confidential data the health care sector: these are the key attributes that Aperio® wireless access control technology brings to a major hospital refurbishment in north-west England.

As part of a £35 million refurbishment of A&E and other urgent care services, Aintree University Hospital in Liverpool sought an upgrade to its access control system. The brief was demanding.

The hospital trust needed flexible access control that could streamline day-to-day security operations, extending public access while also maintaining restrictions to sensitive areas. They wanted a wire-free system, so installation could be done quickly and efficiently, at low cost, without disrupting the day-to-day work of the hospital. Seamless integration between hardware provided by multiple suppliers — including a pre-existing third-party access control system — was also critical.

Finally, Aintree University Hospital needed a solution that would be cost-effective — a crucial factor for this public sector project in an era of tight budget constraints.

ASSA ABLOY partnered with Grantfen and Inner Range to deliver a unified platform, which extended the responsive Integriti access control system with ASSA ABLOY’s Aperio® wireless battery-powered escutcheons.

Aperio® escutcheons proved to be the most cost-effective and easy-to-install security solution for the hospital,” says Sue McIntyre, Grantfen’s General Manager. “Aperio® offered a straightforward alternative to a complicated wired solution, without any need to modify the doors. A particularly useful feature for installing the system quickly and efficiently, without disrupting operations within the live building.”

Aperio® locks are wireless, so there was no need for complex, expensive electrical work during installation. Aperio® saves the hospital money when operational. Cost savings versus traditional wired mag locks doors are significant. Wired locks are powered by an always-on mains electricity supply. Aperio® locks, on the other hand, only “wake up” when activated by a user credential.

Aperio® is built on open architecture, so integration with the existing access control system is seamless. Aperio® components are powered by standard batteries, so maintenance is easy — just a simple battery replacement after 2 years. And because Aperio® is fully scalable, and works with all major standard RFID technologies, it’s easy to bring even more wireless locks into the hospital’s existing access system as the refurbishment continues. Access control at Aintree University Hospital is future-proofed.

For more about Aperio® solutions for hospitals, see www.assaabloy.co.uk/aperioforhospitals

About Aperio®: Available on the global market place, ASSA ABLOY’s Aperio® Technology enables a wide range of access control providers to cost-effectively integrate non-wired doors with mechanical locks into access control systems.

About Aintree University Hospital: Aintree University Hospital is a major teaching hospital and health provider in North Merseyside, providing acute medical care to around 330,000 local residents. The hospital has around 700 inpatient beds and 4600 staff, and deals with almost 154,000 emergency cases and visitors each year. See www.aintreehospital.nhs.uk.

New statement supports switching to biosimilar from reference product in IBD

9th December 2016

Celltrion Healthcare welcomes the publication of the latest position paper from the European Crohn’s and Colitis Organisation (ECCO) on the use of biosimilars for inflammatory bowel disease (IBD), which supports switching from reference infliximab to biosimilar infliximab.1

 The ECCO statement covers several aspects related to biosimilars and the key positions are:1

Switching from the originator to a biosimilar in patients with IBD is acceptable following appropriate discussion between physicians, nurses, pharmacists, and patients, and according to national recommendation.

When a biosimilar product is registered in the EU, it is considered to be as efficacious as the reference product when used in accordance with the information provided in the Summary of Product Characteristics.

Demonstration of safety of biosimilars requires large observational studies with long-term follow-up in IBD patients.

Data for the usage of biosimilars in IBD can be extrapolated from another sensitive indication.

As for all biologics, traceability should be based on a robust pharmacovigilance system.

This marks a significant shift in attitude from the previous ECCO position paper, which advised that switching from an established biologic to a biosimilar was inappropriate and called for more data on the safety and benefit of biosimilars in general.2

Professor Silvio Danese, President Elect of ECCO and Head of the IBD Unit, Humanitas Clinical and Research Center, Italy commented: “This position statement reflects the growing body of data in support of biosimilars, in particular CT-P13. Findings from the 2015 ECCO survey of IBD specialists found that around 80% of specialists are either totally confident, very confident or confident enough in using biosimilars, which is a huge change compared to 39% when a similar survey was conducted back in 2013.”3

Man Hoon Kim, President and CEO of Celltrion Healthcare, said: “This position paper comes amid a global trend encouraging the use of biosimilars. Rising healthcare costs and the consequent financial burden placed on health services are some of the biggest challenges many countries face. While biologics have positively impacted patient treatment, their high costs may limit patient access to these modern medicines. The availability of generally less expensive treatment options like biosimilars can reduce pressure on healthcare system resources.

Biosimilars are a cost effective alternative to biological therapies and can eventually lead to potential budget savings and provide improved access to life-changing treatment for patients.”

Celltrion Healthcare has already seen success with CT-P13 – the world’s first monoclonal antibody biosimilar approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The recently released NOR-SWITCH study revealed that efficacy and safety were maintained in patients switched to CT-P13 from originator infliximab and it is not inferior to those who continued treatment with the originator.4 These findings were presented at the 2016 United European Gastroenterology (UEG) Week in October and at the 2016 American College of Rheumatology (ACR) Annual Meeting in November.

References

  1. Danese S et al. ECCO Position Statement on the use of biosimilars for inflammatory bowel disease – An update. Journal of Crohn’s and Colitis 2016 1–9 doi:10.1093/ecco-jcc/jjw198.
  2. Danese S et al. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). Journal of Crohn’s and Colitis 2013 7(7):586-9. doi: 10.1016/j.crohns.2013.03.011.
  3. Danese S et al. Changes in biosimilar knowledge among European Crohn’s Colitis Organization (ECCO) members. A updated Survey. Journal of Crohn’s and Colitis. 2016 DOI: http://dx.doi.org/10.1093/ecco-jcc/jjw090.
  4. Kvien T et al. Biosimilar infliximab (CT-P13) is not inferior to originator infliximab: Results from a 52-week randomized switch trial in Norway. American College of Rheumatology (ACR) 2016;19L.

Can genetic testing determine antimicrobial susceptibility?

8th December 2016

Experts at the European Committee on Antimicrobial Susceptibility Testing (EUCAST), who define the optimal drug concentrations to inhibit the growth of pathogens, have found that genetic methods cannot yet be used to test for susceptibility in a number of important bacterial species.

Although there have been advances in whole genome sequencing (WGS), which allows to determine the DNA sequence of an organism’s genome at a single time, there are still several hurdles to overcome before this type of genetic testing can be used in clinical laboratories, they concluded.

A EUCAST subcommittee dedicated to reviewing the role of WGS in antimicrobial susceptibility testing (AST) considered the most recent published evidence on the use of whole genome sequencing as a tool for susceptibility testing. The group – comprising of over  a dozen leading experts and led by Prof. Neil Woodford, Head of Public Health England’s Antimicrobial Resistance and Healthcare Associated Infections Reference Unit – did not rule out that it will one day be possible for a single assay to predict how a species of bacteria will respond to a specific antimicrobial drug, but there is little evidence to suggest we will reach this point in the near future.

EUCAST’s technical data coordinator, Prof Gunnar Kahlmeter of the Central Hospital, Växjö, Sweden, said that it is premature to suggest that breakpoints and recommendations for phenotypic susceptibility testing will no longer be required as genetic methods will supersede them any time soon. “To be of use in a clinical situation, WGS will need to predict antimicrobial resistance and also antimicrobial susceptibility, which are two quite different things. It will also be necessary for WGS to quantify the degree of resistance for an organism, something which is currently not possible.”

The group has chosen to compare how WGS can predict whether or not the organism belongs to the wild type (is without resistance mechanisms) with the same prediction performed through the use of the epidemiological cut-off values (ECOFFs) developed by EUCAST. Whether or not and in that case how this can be extended to clinical breakpoints is discussed in the paper.

The EUCAST subcommittee also highlighted that there is currently no way to assess how accurate different WGS laboratories are, and that there is an urgent need to establish a single public database of all known resistance genes within different bacterial species so that data can be shared and compared more easily.

The EUCAST experts also note that WGS technology is currently limited because it cannot be used to analyze specimens directly – bacteria can only be sequenced once they have been cultured. This inevitably leads to significant time delays and additional financial costs, which is usually prohibitive for most laboratories.

EUCAST recommends that WGS should be made a research and funding priority in the future to expand on our current knowledge and to develop more sophisticated prediction tools. As bacteria continue to develop multiple resistance mechanisms, unravelling the genetics of their interaction with antimicrobials will become even more challenging and even more necessary, particularly as we face the spectre of extreme drug resistance and global failure of some antimicrobials.

The full report and the editorial are freely available.

How to keep clinicians happy with IT

The National Health Service (NHS) is evolving. As technology improves, across the system organisations are increasingly embracing the opportunities for improved patient care, and quality data is at the heart of that.

Dame Fiona Caldicott’s review of data security, consent and opt-outs, acknowledges the potential for data to transform the way health and care is delivered, but it also clearly identifies concerns – both inside, and outside the NHS – as to how this data is stored, managed and accessed.

It is a truism that a clinician having access to the right information at the right time – without impediment – will make better decisions. In the past, with this firmly in mind, IT systems have been procured and implemented, with varying degrees of success.

In May this year, at West Suffolk, we pushed the button on a massive transfer of our patient administration system and referral to treatment (RTT) data from our existing legacy system to a new electronic patient record (EPR).

We all understood the risk of getting this wrong. Data supports our hospital staff in managing patients through their care pathways as safely and efficiently as possible. If we can’t track patients through pathways, we might miss them. Our ambition was to improve the quality of this data as we transferred it over. There was an expectation that we would get this right – from board level to the project team.

Define the scope
Moving to a new IT system is a little bit like moving home. You want to ensure that everything great about your old home is kept and transfers to the new one, and is roughly in the same place. Some boxes might be in the wrong rooms, but everything that is important and essential to you moves with you. It’s a simplistic comparison, but it’s apt.

At West Suffolk we were moving much more than a house, we were transferring a huge amount of sensitive data from over 250,000 of our patients seamlessly from our 20-year-old system to a new implementation.

This information needed to be packaged, processed and cleansed before it could be moved. Once moved, it needed to be immediately accessible for our clinicians and administrative staff, whenever and wherever they needed it. And we didn’t need clinicians to tell us that this had to be done with as little downtime or interruption as possible.

Accurate scoping helps to reduce threats. With a clear understanding of the challenge, plans can be drawn up, risks mitigated and fears allayed.

Ask the experts
Moving house is never as straightforward as you hope. You need to package up and protect your belongings, load and transfer them to the new place, unpack them and ensure they’re all there. Like most things, it’s often a lot easier if you use a professional – but in an effort to save money (or face) – many of us choose to go it alone.

The reason is because it’s always difficult – as individuals and as organisations – to recognise gaps in our knowledge and potential areas of weakness. It became clear when scoping the project that our in-house expertise needed to be augmented by that of specialists to boost our capacity and capability.

We worked with Stalis, a specialised data management partner, to complete specific tasks around the migration and cleansing of our data. Working with a partner helped bring structure, specialist tools and techniques as well as knowledge and expertise, all of which helped us to avoid common mistakes that could have dogged our implementation.

A culture of involvement
Central to the success of any change process is convincing those involved and affected by that change that the new system or process will be better than that it replaces. While our existing system may have been almost two decades old, it didn’t mean that staff were ready to change.

Beyond the technical considerations, we needed to persuade staff and clinicians that this wasn’t an IT project by the IT department, but an organisation-wide, clinically-led change project with improved patient care as the focus. We united around the shared belief that the safe transfer of essential data to a new system was going to help us improve patient care.

Central to this is the recognition that high-quality data contributes to high-quality care. The reason is that only by having unimpeded, quick and accurate patient information can we as clinicians truly make the best possible medical decisions on as part of our patient’s care.

The fragmented, ‘best-of-breed’ system approach the trust had previously adopted resulted in organisational information silos. There is no suggestion that this resulted in any issues, but having this all in one place was widely considered to be the way forward for the trust.

While the aspiration for such a system prevailed, the complexity of it, which included managing the data, remained something of a mystery to our clinicians. But they do appreciate that we didn’t screw it up.

In the end, our engagement with clinicians was about focusing on outcomes. We asked what they wanted, and used that as our basis for developing and implementing the system.

Delivering results
Earlier this year we got the keys to the front door and moved in – transferring a substantial amount of data between our systems, going live with the EPR and pulling the plug on the old one. It was a nervous time, but we were confident that our comprehensive data de-cluttering exercise would help to ensure only the necessary information transferred over.

Co-designing the new system allowed us to shoulder the burden from clinicians, reducing the anxieties and reassuring them their requirements would be reflected. Knowing that we understood this means that our clinicians do not need to focus on the system, but can concentrate on patients – which is what we all want and need them to do.

Tagrisso demonstrates superiority over chemotherapy in mutation-positive NSCLC

AstraZeneca has presented data from the AURA3 trial that are supportive of Tagrisso (osimertinib) potentially becoming the new standard of care for second-line treatment of patients with epidermal growth factor receptor (EGFR) T790M mutation-positive locally-advanced or metastatic non-small cell lung cancer (NSCLC).

The first randomised Phase III data showed that Tagrisso second-line therapy improved progression-free survival (PFS) by 5.7 months compared with standard platinum-based doublet chemotherapy (hazard ratio [HR]=0.3).

The results were presented at the 17th World Conference on Lung Cancer (WCLC) in Vienna, Austria, hosted by the International Association for the Study of Lung Cancer, and published simultaneously online in The New England Journal of Medicine.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The confirmatory Phase III data suggest the potential for Tagrisso to replace chemotherapy as the standard of care for patients who have progressed following EGFR tyrosine kinase inhibitor treatment. As lung cancer is the most common type of cancer to spread to the brain, it is also encouraging to see the activity of Tagrisso in patients with central nervous system metastases whose prognosis is often particularly poor.”

AURA3 data showed Tagrisso offered a statistically-significant improvement in PFS versus standard platinum-based doublet chemotherapy (10.1 months vs 4.4 months, HR 0.30; 95% confidence interval (CI):0.23, 0.41; p<0.001). In the 34% of patients with central nervous system (CNS) metastases at baseline, PFS was also significantly greater with Tagrisso than with platinum-based doublet chemotherapy (8.5 months vs 4.2 months, HR 0.32; 95% CI: 0.21, 0.49).

Dr. Vassiliki A Papadimitrakopoulou, from the University of Texas MD Anderson Cancer Center, Houston, Texas, USA, said: “The results of AURA3 are not only statistically significant, but clinically meaningful because it is the first time a targeted agent like Tagrisso has shown improvement in progression-free survival over standard platinum-pemetrexed chemotherapy. It’s very rewarding to be able to give this type of news to patients, as it highlights the major advances we are making in targeted lung cancer treatments.”

Professor Tony Mok, from the Chinese University of Hong Kong, Hong Kong said: “The superiority of Tagrisso in progression-free survival and response rate over platinum-pemetrexed chemotherapy suggests we may be moving towards a new standard of care for patients with resistance to EGFR TKI. With the publication of the AURA3 data, clinicians should perform T790M mutation testing to ensure Tagrisso be given to patients who are most likely to benefit.”​

The AURA3 safety data for Tagrisso were in line with previous experience. Grade ≥3 drug-related adverse events (AEs) were reported in 6% of patients (n=16) treated with Tagrisso and 34% (n=46) treated with platinum-based doublet chemotherapy. The most common drug-related AEs in the Tagrisso the group, were diarrhoea (29% overall; 1% Grade ≥3) and rash (28% overall; <1% Grade ≥3) and, in the chemotherapy group, they were nausea (47% overall; 3% Grade ≥3) and decreased appetite (32% overall; 3% Grade ≥3).

The data for AURA3 are consistent with those previously presented in the Phase II trials, AURA2 and AURA extension. This consistency extends to testing of tissue and plasma samples for the detection of the EGFR T790M resistance mutation. In AURA3, approximately half of patients with T790M in tumour tissue also had the T790M mutation detected in plasma. Clinical benefits were reported with Tagrisso compared to platinum-based doublet chemotherapy, irrespective of whether the T790M mutation was identified by plasma ctDNA or tissue testing. When feasible, tissue testing is recommended for patients with a negative plasma T790M test.

Tagrisso was granted accelerated approval by the US Food and Drug Administration (FDA) in November 2015 for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.  In the EU, Tagrisso was granted conditional marketing authorisation for adult patients with locally advanced or metastatic EGFR T790M NSCLC, irrespective of previous EGFR-TKI treatment by the European Medicines Agency (EMA) in February 2016.

In addition, Tagrisso recieved approval in Japan in March 2016 for the treatment of patients with EGFR T790M mutation-positive inoperable or recurrent NSCLC that is resistant to EGFR-TKI therapy, and it is currently under fast track review in China, where nearly half of lung cancer patients are thought to have the EGFR mutation.

EFFECT-HF demonstrates benefits of Ferinject® in CHF and iron deficiency

EFFECT-HF was a multicentre, randomised, controlled, open-label study conducted in symptomatic patients with stable heart failure and iron deficiency.1 A total of 174 patients from nine countries were randomised to receive either Ferinject® or standard of care for 24 weeks.

The study achieved its primary endpoint, demonstrating a statistically significant benefit with Ferinject® versus standard of care for the change in peak VOafter 24 weeks of treatment. Analysis of secondary efficacy outcomes also found that Ferinject® was associated with significant improvements in New York Heart Association (NYHA) functional class and self-reported Patient Global Assessment (PGA) compared with standard of care.

The results of the EFFECT-HF study were presented at the American Heart Association’s Scientific Sessions 2016 in New Orleans in November. Principal investigator, Professor Dirk van Veldhuisen, University of Groningen, The Netherlands, who presented the findings stated “Iron deficiency is present in approximately 50% of patients with chronic heart failure,2 and has been associated with impaired exercise capacity,3 poor quality of life4 and increased mortality.2 The EFFECT-HF study clearly demonstrates that treatment with ferric carboxymaltose provided a significantly beneficial effect on peak VO2 compared with the control group. These results are in contrast to the findings in the IRONOUT5 study, also presented in the same session at AHA, which showed no effect of oral iron treatment on peak VO2.

The EFFECT-HF study results confirm and extend upon the findings of the FAIR-HF6 and CONFIRM-HF7 studies, which also demonstrated that treatment with Ferinject® was associated with improvements in functional capacity and symptoms, in patients with chronic heart failure and iron deficiency. Building upon this body of evidence, AFFIRM-HF, a new study designed to compare the efficacy and safety of iron therapy with Ferinject® (ferric carboxymaltose) against placebo in patients with acute heart failure and iron deficiency, will begin enrolment shortly.

Overall, the data from EFFECT-HF further reinforce the position of Ferinject® as an effective treatment option for the correction of iron deficiency in chronic heart failure. The 2016 European Society of Cardiology (ESC) Guidelines for the diagnosis and treatment of acute and chronic heart failure, which were released in May this year, recommend that Ferinject® should be considered for the treatment of all symptomatic patients with systolic heart failure and iron deficiency in order to alleviate heart failure symptoms, improve exercise capacity and quality of life.8 These recommendations were based on the findings of the FAIR-HF6 and CONFIRM-HF7 studies.

Multidrug-resistant TB: another facet to the migration crisis in Europe

1st December 2016

A study published in Clinical Microbiology and Infectiondocuments that the rate of infection with multidrug-resistant tuberculosis (MDR-TB) is higher among migrants than in the general population, particularly in those born outside Europe and in those forced to leave their home country as asylum seekers and refugees.1

The data reviewed by Hargreaves et al shows that 100% of the MDR-TB cases diagnosed in Austria, The Netherlands and Norway occurred in migrants to those countries. A high proportion of MDR-TB cases were also apparent in migrants to other European states – 90% in the UK, 89% in France, 87% in Italy and 94% in Germany.

Migrants are at higher risk of contracting MDR-TB both in their country of origin, because of the breakdown of their own healthcare system, and after arriving in Europe, because of destitution, homelessness, overcrowding in refugee camps or incarceration. A significant proportion of MDR-TB cases in migrants result from reactivation of latent infection.

Screening, diagnosis and treatment is available for all forms of TB, including active MDR-TB. However, this is rarely accessed by migrants due to restrictions set by healthcare systems or to fear on the part of the migrants that becoming known to the authorities might result in deportation back to the violence they have fled.

Although there is evidence that transmission of TB from migrants to the general population is low – it predominantly occurs between migrants – there is a risk of transmission for both migrants and the native population,” notes Professor Jon S Friedland of the International Health Unit, Infectious Diseases & Immunity, Imperial College London, UK, who is senior author of the study. “There is a human rights obligation to improve the diagnosis, treatment and prevention of MDR-TB in migrants.”

So what needs to be done?

After analysing the content of several studies on MDR-TB, the paper recommends a multi-faceted strategy to improve access to services, more consistent pan-European protocols for screening and treatment, and further research to document the level of MDR-TB infection in the European migrant population.

Detailed recommendations include:

·       Changing healthcare policies so that there are fewer barriers to migrants with respect to TB screening, diagnosis and treatment. This would not be granting ‘favours’ to migrants; it would be a sound public health policy to reduce the risk of MDR-TB transmission to other migrants and the wider population.

·       Providing better healthcare generally to migrant populations in individual host countries.

·       Developing financial and social support mechanisms for migrants who are diagnosed with MDR-TB.

·       Drawing up and adopting pan-European evidence-based guidelines for screening methods and how to implement them in the migrant populations.

·       Research is also required to develop a reliable diagnostic test that can detect latent MDR-TB and to predict the risk of disease re-activation.

·       We also need more evidence that can be used to develop guidelines on how to manage MDR-TB more effectively in migrant populations across Europe.

Friedland highlights that we have a serious “lack of data on effective screening strategies for MDR-TB or how routine practice should be adapted across diverse health systems in Europe to improve treatment outcomes in migrants at risk of low adherence to TB treatment or with MDR-TB.

Reference

  1.  Hargreaves S et al. Multidrug-resistant tuberculosis and migration to Europe. Clin Microbiol Infect 2016. http://dx.doi.org/10.1016/j.cmi.2016.09.009

Positive NICE recommendation for GSK’s Nucala for severe asthma

The National Institute for Health and Care Excellence (NICE) has today announced a positive recommendation for GSK’s Nucala®(mepolizumab) for use in a sub-group of adults with severe refractory eosinophilic asthma in England and Wales.1

Mepolizumab is the first biologic therapy that targets interleukin-5 (IL-5) in severe asthma. IL-5 plays an important role in regulating the production and survival of eosinophils, an inflammatory cell known to be important in this disease. This first in class biological medicine targeting this specific type of severe asthma is now also the first to be granted national access by NICE. It will be made available to patients in specialist centres providing severe asthma services.

For many of the 4.8 million people with asthma in England and Wales,2 existing therapies can provide adequate control of their symptoms if used appropriately.3 However, a significantly smaller group of people with severe refractory eosinophilic asthma remain at high risk of asthma attacks.4 These patients have few treatment options available to them,4 are higher users of healthcare resources5 and could be suitable for this new treatment.

Commenting on the decision, Dr Stephen McDonough, GSK’s UK and Ireland Medical Director, said “This is great news for eligible adult patients in England and Wales living with severe refractory eosinophilic asthma. It will enable healthcare professionals to offer a targeted treatment to this small but difficult-to-treat group of patients. Severe asthma is a debilitating condition. For many patients, despite taking high doses of inhaled medicines, and often oral corticosteroids, their condition remains uncontrolled putting them at high risk of frequent and serious asthma attacks which can sometimes end up with them being hospitalised.”

NICE’s decision follows marketing authorisation in Europe in December 2015 and positive restricted advice by the Scottish Medicines Consortium for use within NHS Scotland in June 2016.6

References

  1.  Official NICE guidance 2016 [online]. Available at https://www.nice.org.uk/guidance.
  2. Asthma UK. Asthma facts and FAQs. [online]. Available from: http://www.asthma.org.uk/asthma-facts-and-statistics  [Last accessed: November 2016]
  3. American Thoracic Society 2000. Proceedings of the ATS Workshop on Refractory Asthma [online]. Available from: https://www.thoracic.org/statements/resources/allergy-asthma/refracasthma.pdf. [Last accessed: November 2016]
  4.  Peters et al. (2006) Uncontrolled asthma: A review of the prevalence, disease burden and options for treatment. Respiratory Medicine: 100, 1139–1151.
  5. Campo et al. (2013). Phenotypes and Endotypes of Uncontrolled Severe Asthma: New Treatments. J Investig Allergol Clin Immunol; Vol. 23(2): 76-88
  6. Official SMC guidance 2016 [online]. Available at http://www.scottishmedicines.org.uk/SMC_Advice/Advice/1149_16_mepolizumab_Nucala/mepolizumab_Nucala [Last accessed: November 2016]