Archive for month: February, 2024

Sweden: A recent study published in the Journal of Electrocardiology has shed light on the sensitivity and specificity of handheld one-lead ECG detecting atrial fibrillation (AF) in an outpatient clinic setting.

Austria: The European Alliance of Associations for Rheumatology (EULAR) has released recommendations on imaging for diagnosing and managing crystal-induced arthropathies (CiAs) in clinical practice.

A therapist-guided digital cognitive behavioural therapy reduced distress in 89 per cent of participants living with long-term physical health conditions, a new King’s College London study finds.

Researchers at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London found that people living with long-term conditions who received the therapist-guided digital programme called COMPASS showed a significant reduction in psychological distress (a combined score of anxiety and depression) 12-weeks after starting the study.

194 patients were recruited via long-term condition charities, including Crohn’s & Colitis UK, Kidney Care UK, MS Society, Shift.ms and Psoriasis Association in the UK. Half of the participants received the COMPASS programme and the other half did not. Both groups continued to access their usual charity support.

Overall, 89 per cent of participants who received COMPASS showed a clinically significant improvement in distress, compared to 45 per cent of those who did not have access to the programme. Alongside improvements in anxiety and depression, COMPASS was also associated with improved ability to undertake daily activities, reduction in illness-specific distress and better quality of life.

An estimated 15.4 million people in England have one or more long-term physical health conditions. 30 per cent of these individuals also have a co-occurring mental health condition. The study, published in Psychological Medicine, is the first randomised controlled trial to measure the effectiveness of COMPASS for managing anxiety and depression related to living with a long-term condition.

The research was part-funded by the National Institute for Health and Care Research (NIHR) Maudsley Biomedical Research Centre.

Dr Federica Picariello, post-doctoral health psychology research associate at King’s IoPPN and joint first author of the study, said: “Currently, the main treatments for anxiety and depression in people with long-term physical health conditions are psychotherapies, such as cognitive behavioural therapy, combined with medication. However, growing evidence shows that NHS Talking Therapies services are less effective for people with long-term physical health conditions. This may be because the challenges of living with the long-term physical health condition are often not central to the treatment approach. Our study shows that COMPASS offers an effective and potentially scalable intervention for people whose long-term physical health condition is, in fact, the key driver for their anxiety and/or depression.”

Developed with the support of the Mind and Body Programme at King’s Health Partners, COMPASS adapted standard cognitive behavioural therapy (CBT) protocols to integrate mental and physical health needs and specifically address the challenges of living with a long-term health condition. Using interactive pathways tailored to the individual’s needs, the programme helps people manage their symptoms of anxiety and depression alongside building strategies to manage stressors associated with living with a long-term condition, such as relapses or unpleasant treatments.

Dr Katrin Hulme, post-doctoral health psychology research associate at King’s IoPPN, and joint first author of the study, said: “This trial is the culmination of several years of work, starting in 2018; throughout the project, we developed the COMPASS programme and training for therapists, conducted user testing, got regulatory approval, launched in healthcare clinics and conducted this trial. The valuable insights of our patient and clinician representatives helped us create an online programme specifically tailored to help people manage the challenges that can come with living with a long-term health condition, and support healthcare services in addressing this unmet need.”

After 12 weeks, during which participants could complete any of the 11 interactive digital COMPASS sessions as home and receive up to five 30-minute support calls with their therapist, patients who received COMPASS reported greater improvements in most outcomes compared to those who did not have access to the programme.

Simon Brodie, a participant in the study said: “As a person with Multiple Sclerosis, my life had changed significantly as a direct result of my diagnosis. Due to thankfully being part of the COMPASS trial, I feel empowered and confident to deal with changes and emotions that life throws at you as a person with a long-term condition. COMPASS directs you to areas of your life you’d like to improve and explore by enabling skills, providing supported tools to guide you with along your journey. I highly recommend to those in the MS community as a best practice.”

As the treatment can be administered remotely, the study authors suggest an efficient delivery pathway could be through a national hub linked to self-referral through charities or the NHS, rather than setting up within each regional primary or secondary health service with limited resources. This delivery pathway could alleviate the demand on charities who already provide some essential support services and enable them to facilitate access to further specialised treatment.

The findings highlight that the use of digital interventions, such as COMPASS, which place the long-term physical health condition at the centre of treatment for anxiety and depression, are effective, scalable, and can be delivered with minimal therapist time.

Senior author, Professor Rona Moss-Morris, Digital Therapies theme lead at NIHR Maudsley BRC and Professor Psychology as Applied to Medicine at King’s College London, said: “Accessing psychological therapies which are tailored to the needs of people with long-term conditions is challenging for both the patient (due to time, travel, and/or mobility) and healthcare providers (due to treatment costs and availability of adequately trained therapists). As a CE-marked digital therapy with minimal therapist input, COMPASS offers a potential solution to overcome some of these challenges, whilst being an effective intervention to reduce psychological distress.”

Reference:

Picariello F, Hulme K, Seaton N, et al. A randomized controlled trial of a digital cognitive-behavioral therapy program (COMPASS) for managing depression and anxiety related to living with a long-term physical health condition. Psychological Medicine. Published online 2024:1-14. doi:10.1017/S0033291723003756.

Researchers have shown that the drug benralizumab is as effective and safe as mepolizumab for inducing remission in patients with eosinophilic granulomatosis with polyangiitis (EGPA) according to a study published today in The New England Journal of Medicine. The results of the non-inferiority study were presented at the American Academy of Allergy, Asthma & Immunology annual meeting in Washington, D.C., by Michael Wechsler, M.D., pulmonologist, director of The Cohen Family Asthma Institute at National Jewish Health and lead author of the paper.

EGPA is a rare form of vasculitis, characterized by inflammation in the small blood vessels. This inflammation causes restriction of blood flow, which can cause organ damage if left untreated. The cause of the disease is unknown, and it affects people differently depending on which organs are impacted. It is estimated that 50,000 individuals suffer from EGPA.

Oral glucocorticoids and medications that suppress the immune system have been the standard treatment for EGPA, but they can come with damaging side effects. Targeting inflammation caused by eosinophils (a type of white blood cell) is another well-recognized treatment for EGPA, and mepolizumab became the first FDA-approved treatment for EGPA in 2017. Benralizumab is currently approved for the treatment of severe eosinophilic asthma, suggesting it might also be a treatment for EGPA.

“By showing that benralizumab has comparable results to mepolizumab in the safe treatment of EGPA, we have added another potential option in the arsenal to help patients of this rare disease,” said Dr. Wechsler. “While both drugs showed similar disease remission, relapse and safety impacts, we observed benralizumab did a better job in reducing the need of oral glucocorticoids and lower blood eosinophil counts. This was achieved using fewer injections of benralizumab, which also could be a benefit to the patient.”

The study randomized 140 patients who received either one 30 mg injection of benralizumab or three 100 mg injections of mepolizumab every four weeks for 52 weeks. The primary analysis was to evaluate the non-inferiority of benralizumab versus mepolizumab. The results suggest that targeting eosinophils as a therapeutic strategy in EGPA can lead to a higher number of patients achieving remission, and a lower number experiencing relapse. Achieving these results while seeing substantial reductions in oral glucocorticoids use provides further evidence of the role of eosinophils in EGPA.

“Though further studies are needed, our results indicate that eliminating oral glucocorticoids may now be an achievable treatment goal while using eosinophil-targeted drugs for EGPA,” said Dr. Wechsler.

Reference:

Michael E. Wechsler, Parameswaran Nair, Benjamin Terrier, Bastian Walz,  Arnaud Bourdin, David R.W. Jayne, David J. Jackson, Florence Roufosse, Lena Börjesson Sjö, Ying Fan, Maria Jison, Benralizumab versus Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis, New England Journal of Medicine, DOI: 10.1056/NEJMoa2311155.

Recombinant protein vaccines, like the Novavax vaccine used to fight COVID-19, offer several advantages over conventional vaccines.

They’re easy to precisely produce. They’re safe, and potentially more effective. And they could require smaller doses.

Because of these traits, there is much interest in developing recombinant influenza vaccines. To date, however, the Food and Drug Administration has approved only one such vaccine.

A University at Bufalo-led research team hopes to add to that number. It is developing a new recombinant flu vaccine – described in a study published today in the journal Cell Reports Medicine – that has the potential to compete with existing vaccines.

“Because of the variable nature of the viruses that cause influenza, current vaccines are not optimally effective among the overall population. We believe our vaccine candidate has the potential to improve upon this by inducing stronger and broader immunity, and reducing the likelihood of illness and death,” says study senior co-author, Jonathan Lovell, PhD, SUNY Empire Innovation Professor in the Department of Biomedical Engineering at UB.

Conventional flu vaccines contain either deactivated microbes that cause influenza, or they are based on weakened forms of the disease. They are made using fertilized chicken eggs or, less commonly, through cell culture-based production.

The vaccine the UB-led team is developing is based on a nanoliposome – a tiny spherical sac – that Lovell and colleagues created called cobalt-porphyrin-phospholipid, or CoPoP. The CoPoP platform enables immune response promoting proteins to be displayed on the surface of the nanoliposome, resulting in potent vaccine efficacy.

(While not part of this study, the CoPoP vaccine platform underwent phase 2 and phase 3 clinical trials in South Korea and the Philippines as a COVID-19 vaccine candidate. This is a partnership between UB spinoff company POP Biotechnologies, co-founded by Lovell, and South Korean biotech company EuBiologics.)

Alone, these nanoliposomes do not fight disease. But when combined with recombinant influenza proteins that can be generated based on genetic information from viruses, they enhance the immune system’s response to disease.

In the new study, the team attached to the nanoliposome a total of six proteins – three each from two different protein groups, hemagglutinins and neuraminidases. The team also added two adjuvants (PHAD and QS21) to boost immune response.

Researchers evaluated the resulting “hexaplex” nanoliposome in animal models with three common flu strains: H1N1, H3N2 and type B.

Even when administered in low doses, the hexaplex nanoliposome provided superior protection and survival from H1 and N1 when compared to Flublok, which is the sole licensed recombinant influenza vaccine in the U.S., and Fluaid, an egg-based vaccine. Tests showed comparable levels of protection against H3N2 and type B viruses.

The tests were performed via vaccination and through blood serum transfer from vaccinated mice into non-vaccinated mice.

“The combination of the two groups of proteins led to synergistic effects. In particular, the adjuvanted nanoliposomes excelled in the production of functional antibodies and the activation of T cells, which are critical to fighting off serious infection of the flu,” says lead author Zachary Sia, a PhD candidate in Lovell’s lab.

Bruce Davidson, PhD, research associate professor of anesthesiology in the Jacobs School of Medicine and Biomedical Sciences at UB, is a senior co-author of the study.

He says “using not only hemagglutinin but also neuraminidase antigens to create vaccines is important because it translates into broader immunity and companies will be able to create more doses with less materials. That’s critical for not only the flu but also potential outbreaks like what we saw with COVID-19. There is still much work to be done in fully testing and validating this flu technology, but at this point these early results are quite promising.”