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5th December 2019
The trial, led by the Murdoch Children’s Research Institute (MCRI) and published in Allergy: European Journal of Allergy and Clinical Immunology, saw specially trained paediatricians working in community clinics, where they could provide front-line allergy treatment and management advice. Children with three or fewer suspected food allergies took part in the trial while those with suspected anaphylaxis (a more severe type of food allergy) or more than three food allergies were excluded.
The trial resulted in faster assessment times, was more acceptable to families, and delivered similar quality of allergy care to specialist hospital-based clinics.
Based on these results, the trial team is calling for investment in a larger program to train community paediatricians, especially in regions where there are no child allergy specialists.
Lead author, MCRI’s Professor Harriet Hiscock, said 63% of those seen by a paediatrician in the community were treated without needing an allergist referral, freeing up valuable hospital resources.
“As rates of food allergy rise, specialist allergy services are valiantly struggling to manage demand, but waiting times to access these services are long,” Professor Hiscock said.
“In many regions around Australia, allergy care is primarily delivered by allergists, due to limited allergy training opportunities for general pediatricians and primary care physicians.”
Professor Hiscock said the study, which involved children aged 0-12 years, was the first to evaluate this community-based approach. A key component of the program is providing specialised allergy training to general paediatricians.
The study found out of the 115 participants in the community group, 81% saw a paediatrician by 12 months. This compared to 28% of 181 patients who received care at the RCH Allergy Clinic. Of these, 60% had not received an appointment at 12 months.
Time to assessment was also shorter, 2.4 months for a community paediatrician compared to 12 months for a hospital allergist.
Professor Hiscock said children in the community group reported fewer reactions to food and families were more satisfied with the overall process.
The site will be evaluating Rexgenero’s REX-001 in two Phase III trials, codenamed the SALAMANDER trials. The trials are being led by Mr Ian Williams, a Consultant Vascular Surgeon and the Principal Investigator at the site.
The University Hospital of Wales is participating in the trials through a consortium, the Midlands-Wales Advanced Therapy Treatment Centre (MW-ATTC), part of the Advanced Therapy Treatment Centre Network (ATTC) which aims to bring pioneering advanced therapy medicinal products (ATMPs) to patients. THE MW-ATTC has been working in collaboration with the Cardiff & Vale University Health Board to progress the initiation of the two SALAMANDER trials and is planning to activate new clinical trial sites in the Midlands in England shortly.
REX-001 represents a new class of regenerative medicines. It is an autologous cell therapy manufactured using the patient’s own bone marrow and consists of immune cells (lymphocytes, monocytes and granulocytes) and progenitor cells involved in immune modulation and tissue regeneration. It is administered as a single dose within 4 days after collection of bone marrow cells.
Ian Williams, Consultant Vascular Surgeon and Principal Investigator commented, “Chronic limb-threatening ischaemia is a serious disease with severe consequences and limited treatment options. There is a high unmet need for novel and innovative therapies – such as REX-001 – that have the potential to be a highly effective treatment and to reduce amputation and mortality rates amongst the patient population.”
Rexgenero, the company pioneering the development of REX-001, says that the experimental product has already demonstrated efficacy in Phase I/II studies. In the Phase II clinical trial, 82% of patients with non-healing ischaemic ulcers were healed within the first 12 months after a single administration dose of REX-001.
Joe Dupere, CEO of Rexgenero added, “Treating our first patient with REX-001 in the UK represents an important milestone for our Phase III program in diabetic patients with chronic-limb threatening ischaemia, a severe condition with high unmet need. With clinical trial sites and manufacturing bases now open across multiple countries in Europe, we are one step closer to completion of the Phase III studies and potential regulatory and market approval for an innovative and much-needed product.”
The trial is planning to treat a total of 60 patients with CLI and rest pain and 78 patients with CLI and non-healing ischaemic ulcers in two independent Phase III SALAMANDER trials in approximately 25 hospitals across Europe. In addition to the trial sites in the UK, recruitment for both trials at sites in Spain, Austria, Portugal, Poland, Hungary, the Netherlands and the Czech Republic is underway.
The American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) have released the 2019 ACR/EULAR Classification Criteria for IgG4-Related Disease.
It is the first criteria developed specifically for this recently recognised disease.
A draft of the criteria was presented during the 2018 ACR/ARP Annual Meeting in Chicago. Since that time, the criteria team performed a second validation study, which confirmed the high sensitivity and specificity that was found in the first validation study.
IgG4-Related Disease (IgG4-RD) is an immune-mediated disease that may affect different organ systems and often mimics other diseases like Sjögren’s syndrome, pancreatic cancer, granulomatosis with polyangiitis (GPA), giant cell arteritis (GCA) and systemic lupus erythematosus (SLE or lupus).
Only recognised in the last 10 to 15 years, IgG4-RD can cause fibro-inflammatory lesions in nearly any organ or multiple organs. Estimates suggest that IgG4-RD affects 180,000 people in the United States and many more worldwide.
“IgG4-RD is now recognised to be a worldwide condition that is seen not only by rheumatologists but also generalists and sub-specialists of nearly every kind,” said John H Stone, professor of medicine at Harvard Medical School and director of the international panel of experts who developed the new criteria. “Clinical trials are now being developed in IgG4-RD and investigators need criteria on which to base patients’ inclusion or exclusion for such trials and other types of investigation.”
Classification criteria allow researchers to accurately identify patients for inclusion in clinical, epidemiologic and basic investigations. The panel of experts who developed the new classification criteria included investigators from rheumatology and other specialties from five continents, reflecting the worldwide impact of this disease.
In the criteria, classifying patients with IgG4-RD is a three-step process that carefully assesses data from four domains, which must make sense in the context of IgG4-RD. The process includes synthesising information from the patient’s clinical presentation, blood test results or serology, radiological findings and the pathology data. Few other diseases require such careful synthesis of various information to get an accurate diagnosis, and at this time, there is no single diagnostic test for the disease.
The 2019 ACR/EULAR Classification Criteria for IgG4-Related Disease were validated in a large cohort of patients and demonstrated excellent test performances. Dr. Stone feels they should be a highly useful contribution to future investigations in this disease, and will ultimately help improve the lives of patients with IgG4-RD.
“IgG4-RD is a disease that tends to afflict middle-aged to elderly individuals and often affects and damages the pancreas severely, making glucocorticoids a suboptimal therapy for this condition,” Dr Stone said. “Clinical trials will help develop targeted therapies that spare toxicities from conventional treatments. Investigators need to have criteria like this to determine whether a patient should be classified as having IgG4-RD.”
2nd December 2019
The researchers say that their review of existing literature, published in Molecular Psychiatry, highlights how little research has been done into one of the world’s major killers, particularly among the most vulnerable groups.
The facts in relation to suicide are stark: 800,000 people die globally by suicide every year, the equivalent of one every 40 seconds. Suicide is the second leading cause of death globally among 15–29 year olds. More adolescents die by suicide than from cancer, heart disease, AIDS, birth defects, stroke, pneumonia, influenza, and chronic lung disease combined. As many as one in three adolescents think about ending their lives and one in three of these will attempt suicide.
“Imagine having a disease that we knew killed almost a million people a year, a quarter of them before the age of thirty, and yet we knew nothing about why some individuals are more vulnerable to this disease,” said Dr Anne-Laura van Harmelen, co-first author from the University of Cambridge. “This is where we are with suicide. We know very little about what’s happening in the brain, why there are sex differences, and what makes young people especially vulnerable to suicide.”
A team of researchers, including Hilary Blumberg, MD, John and Hope Furth Professor of Psychiatric Neuroscience at Yale, carried out a review of two decades’ worth of scientific literature relating to brain imaging studies of suicidal thoughts and behaviour. In total, they looked at 131 studies, which covered more than 12,000 individuals, looking at alterations in brain structure and function that might increase an individual’s suicide risk.
They identified two brain networks – and the connections between them – that appear to play an important role.
The first of these networks involves areas towards the front of the brain known as the medial and lateral ventral prefrontal cortex and their connections to other brain regions involved in emotion. Alterations in this network may lead to excessive negative thoughts and difficulties regulating emotions, stimulating thoughts of suicide.
The second network involves regions known as the dorsal prefrontal cortex and inferior frontal gyrus system. Alterations in this network may influence suicide attempt, in part, due to its role in decision making, generating alternative solutions to problems, and controlling behaviour.
The researchers suggest that if both networks are altered in terms of their structure, function or biochemistry, this might lead to situations where an individual thinks negatively about the future and is unable to control their thoughts, which might lead to situations where an individual is at higher risk for suicide.
“The review provides evidence to support a very hopeful future in which we will find new and improved ways to reduce risk of suicide,” said Professor Hilary Blumberg. “The brain circuitry differences found to converge across the many studies provide important targets for the generation of more effective suicide prevention strategies. “It is especially hopeful that scientists, such as my co-authors on this paper, are coming together in larger collaborative efforts that hold terrific promise.”
The majority of studies so far have been cross-sectional, meaning that they take a ‘snapshot’ of the brain, rather than looking over a period of time, and so can only relate to suicidal thoughts or behaviours in the past. The researchers say there is an urgent need for more research that looks at whether their proposed model relates to future suicide attempts and at whether any therapies are able to change the structure or function of these brain networks and thereby perhaps reduce suicide risk.
The review highlighted the paucity of research into suicide, particularly into sex differences and among vulnerable groups. Despite suicidal thoughts often first occurring as early as during adolescence, the majority of studies focused on adults.
“The biggest predictor of death by suicide is previous suicide attempt, so it’s essential that we can intervene as early as possible to reduce an individual’s risk,” said co-first author Dr Lianne Schmaal from the University of Melbourne. “For many individuals, this will be during adolescence. If we can work out a way to identify those young people at greatest risk, then we will have a chance to step in and help them at this important stage in their lives.”
Even more striking, despite the fact that transgender individuals are at increased risk for suicide, just one individual in the 131 samples included for the review was identified to be transgender.
In 2018, the researchers launched the HOPES (Help Overcome and Prevent the Emergence of Suicide) study, supported by the mental health research charity MQ. HOPES brings together data from around 4000 young people across 15 different countries in order to develop a model to predict who is at risk of suicide. Over the course of the project, the team will analyse brain scans, information on young people’s environment, psychological states and traits in relation to suicidal behaviour from young people from across the world, to identify specific, universal risk-factors.
29th November 2019
This technology could revolutionise the serodiagnosis of microbial, autoimmune and allergic disorders.
Now this team of researchers have applied the new concept for diagnostics of coeliac disease.
Screening of coeliac disease is recommended for patients with, for example, gastrointestinal coeliac patients. The screening test involves measurement of disease-specific antibodies from a blood sample.
The researchers gathered samples from 70 coeliacs at the Kuopio University Hospital, half from children and half from adults. Control samples from healthy donors were also collected. The samples were measured using the new assay and results compared with two currently used methods.
“The performance of the test was comparable to that of current methods. The prevailing method involves transporting the sample to a central laboratory and a multi-step procedure taking hours. With the new method, results can be achieved in less than half an hour by simply combining the sample and a reagent mix, waiting for a while and reading the result.”, Juuso Rusanen, MD, explains. He continues:
“We hope our rapid method could lower the threshold for screening of coeliac disease and thus help overcome the vast underdiagnosis of this relatively common condition.”
“Additionally, this is the first time the new method has been used for diagnostics of autoimmune disease. This is a promising result, and prompts the development of similar tests for diagnostics of other autoimmune disorders“, Rusanen points out.
It’s very well-evidenced that convulsive status epilepticus (SE) requires urgent treatment to reduce the risk of permanent harm to the patient.
Achieving seizure control within the first one to two hours is an independent predictor of patient outcomes, including significant disability and mortality.1
Using benzodiazepines as a first course of action is well established, and if given promptly and in sufficient doses will abort seizures in up to 70% of patients. However, best practice beyond this has been far less clear for treating this life-threatening condition.
That is, until the results of the Established Status epilepticus Treatment Trial (ESETT) trial were published this week in the New England Journal of Medicine – providing much needed results on what to do when first-line therapy fails.2
If benzodiazepines fail to work, the decision to administer a second drug needs to be taken within five to 10 minutes, with phenytoin being the traditional choice and the only drug licensed for use in SE. Newer alternatives, specifically valproate and levetiracetam have gained popularity, but until now not been rigorously evaluated in a clinical trial setting, leaving clinicians uncertain as to which drug to use and at what doses.
Our double blind randomised controlled trial in 384 patients showed that all three drugs are effective in stopping seizures in around half of patients that have not responded to benzodiazepines, sparing many patients from endotracheal intubation and intensive care unit stays. Each drug was found to be equally effective in stopping seizures, with no significant differences in terms of drug safety when comparing across outcomes including life-threatening hypotension, heart problems, seizure recurrence and death.
Cumulative trials in SE over the years now support an evidenced based sequence of treatment, to which the vast majority of patients will SE will respond. These started 20 years ago with the Veterans Affairs co-operative3 and Pre-Hospital Treatment of SE studies,4 through to the 2012 RAMPART study.5 This list now includes ESETT and two open paediatric studies also published this year, ConSEPT6 and EclipSE.7
Looking at the broader picture, I believe valproate and levetiracetam have other practical advantages making them preferable to phenytoin.
Phenytoin takes at least double the time (20 minutes or more) to administer, and can exacerbate seizures in some types of epilepsy, with multiple potential drug interactions in an already critically ill population often needing multiple medications. Life threatening hypotension and cardiac arrhythmias, which are already risks in SE, are also recognised side effects not seen with the other agents.
When it comes to maintenance therapy, phenytoin is rarely used as it has been superseded by newer agents with better tolerability profiles, including valproate and levetiracetam. Finally, of reports over five years to the UK National Patient Safety Agency,8 phenytoin was the only drug where loading dose errors were associated with fatalities.
The results from ESSET should give clinicians the confidence to use valproate or levetiracetam to treat SE using the high loading doses utilised in the study.
Our focus now must include ways to better prevent or treat the remaining refractory SE patients, and putting the evidence we do have into practice. A sub-study within ESETT also demonstrated frequent under-dosing with benzodiazepines,9 and in my own centre and elsewhere I know the same is often true of second line agents.
We need to trust the evidence we have, be braver with dosing and act quickly with the effective medications we have. If we follow guidance and take prompt action, we will all be better set to provide the best care and save lives.
References
About the author
Hannah Cock is Professor of Epilepsy and Medical Education at St George’s, University of London, and a consultant neurologist in the Atkinson Morley Regional Epilepsy Network at St George’s University Hospitals NHS Foundation Trust. She has been involved in status epilepticus research for over 20 years, is now course director for medicine at St George’s, University of London, and the local Status Epilepticus lead.
Declaration
Prof Cock was a principal investigator on the ESETT study, funded by Grants U01NS073476, U01NS088034, U01NS088023, U01NS056975, U01NS059041, and R01NS099653 from the National Institute of Neurological Disorders and Stroke, USA. She also reports: personal fees from Sage Pharmaceuticals Ltd, from Eisai Europe Ltd, UCB Pharma Ltd, UK Epilepsy Nurse Specialist Association, Bial and Eisai outside the submitted work. Also non-financial support from Special Products Ltd, the International League Against Epilepsy Epilepsy Certification (education) Task Force, and the European Academy of Neurology.
Scientists pioneered the test which diagnoses aggressive prostate cancer and predicts whether patients will require treatment up to five years earlier than standard clinical methods.
Their latest study shows how the ‘PUR’ test (Prostate Urine Risk) could be performed on samples collected at home, so men don’t have to come into the clinic to provide a urine sample – or have to undergo an uncomfortable rectal examination.
This is an important step forward, because the first urination of the day provides biomarker levels from the prostate that are much higher and more consistent. And the research team hope that the introduction of the ‘At-Home Collection Kit’ could revolutionise diagnosis of the disease.
Lead researcher Dr Jeremy Clark, from UEA’s Norwich Medical School, said: “Prostate cancer is the most common cancer in men in the UK. It usually develops slowly and the majority of cancers will not require treatment in a man’s lifetime. However, doctors struggle to predict which tumours will become aggressive, making it hard to decide on treatment for many men.
“The most commonly used tests for prostate cancer include blood tests, a physical examination known as a digital rectal examination (DRE), an MRI scan or a biopsy.
“We developed the PUR test, which looks at gene expression in urine samples and provides vital information about whether a cancer is aggressive or ‘low risk‘.
“Because the prostate is constantly secreting, the collection of urine from men’s first urination of the day means that the biomarker levels from the prostate are much higher and more consistent, so this is a great improvement.
“Being able to simply provide a urine sample at home and post a sample off for analysis could really revolutionise diagnosis.
“It means that men would not have to undergo a digital rectal examination, so it would be much less stressful and should result in a lot more patients being tested.”
The research team provided 14 participants with an At Home Collection Kit, and instructions. They then compared the results of their home urine samples, taken first thing in the morning, with samples collected after a digital rectal examination.
“We found that the urine samples taken at home showed the biomarkers for prostate cancer much more clearly than after a rectal examination. And feedback from the participants showed that the at home test was preferable.
“Using our At Home test could in future revolutionise how those on ‘active surveillance’ are monitored for disease progression, with men only having to visit the clinic for a positive urine result. This is in contrast to the current situation where men are recalled to the clinic every six to 12 months for painful and expensive biopsies.
“Because the PUR test accurately predicts aggressive prostate cancer, and predicts whether patients will require treatment up to five years earlier than standard clinical methods – it means that a negative test could enable men to only be retested every two to three years, relieving stress to the patient and reducing hospital workload.”
The Norfolk and Norwich University Hospital receives more than 800 referrals a year to investigate and treat potential prostate cancers. Prostate cancer usually develops slowly and the majority of cancers will not require treatment in a man’s lifetime.
Robert Mills, Consultant Surgeon in Urology at the Norfolk and Norwich University Hospital, said: “This is a very exciting development as this test gives us the possibility of differentiating those who do from those who do not have prostate cancer so avoiding putting a lot of men through unnecessary investigations.
“When we do diagnose prostate cancer, the urine test has the potential to differentiate those who need to have treatment from those who do not need treatment, which would be invaluable. These patients go on to an active surveillance programme following the diagnosis which may involve repeat biopsies and MRI scans which is quite intrusive. This urine test has the potential to tell us whether we needed to intervene with these patients.”
The research team say that their findings could also help pioneer the development of home-collection tests for bladder or kidney cancer.
28th November 2019
The research, by scientists at leading institutions in the US and UK and supported by the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, involved 384 patients who were treated for status epilepticus across 57 hospitals in the US. By randomly assigning patients to receive one of the three drugs, they found that each drug stopped the seizures in around half the patients, saving many from admission to intensive care and associated complications.
Status epilepticus is the name for any seizure that lasts a long time, or a series of seizures where the person doesn’t regain consciousness in between. It can occur in patients at any age. Only around half of status epilepticus cases are in people with a history of epilepsy, with other common causes including stroke, brain injury or infections.1 The condition can be life-threatening with around 15 in 100 cases resulting in death.2
The initial treatment for patients is the sedative drug, benzodiazepine. This works for up to 7 out of 10 patients if given promptly in adequate doses.3 However for those that don’t respond, the only licensed drug is phenytoin, or its pro-drug fosphenytoin. The researchers aimed to gather evidence on the efficacy and safety of fosphenytoin, as well as newer alternative drugs levetiracetam and valproate, as a second line treatment. Both are established treatments for epilepsy, but not licensed for use in status epilepticus.
The study results showed the drugs were equivalent in terms of effectiveness in stopping seizures. Similarly, there were no clear differences in terms of drug safety when comparing across outcomes including life-threatening hypotension, heart problems, seizure recurrence and death.
The number of life-threatening safety events recorded in the trial was low, without any clear difference between groups in terms of safety, and provides evidence that high doses of levetiracetam and valproate as used in the study are safe alternatives to phenytoin.
Professor Hannah Cock, co-author of the study from St George’s, University of London and St. George’s University Hospitals NHS Foundation Trust, said: “The sooner seizures can be ended, the better the outcome for patients. At St George’s we get convulsive status epilepticus patients at least once per week, and we want to treat them quickly with best practice care.
“Our results show that we now have two other options to give to patients who need urgent care, and should give doctors the confidence to use these other medicines.”
The researchers used a clinical trial design known as response adaptive randomisation to improve the study’s efficiency and maximise the chances of identifying the best treatment. The study used an algorithm to determine which drugs patients would receive based on accumulating trial data.
Jaideep Kapur, MB BS, PhD, professor at the University of Virginia and co-lead author of the study, said: “Using an innovative design for this clinical trial, we were able to answer this important question in a timely and cost-effective manner.
“In addition, this design lowered risk by reducing the chances that participants could have received what might have been determined to be the least effective treatment.”
The next steps for the research team will be to assess treatment options for patients with refractory status epilepticus, where patients show no response to the initial benzodiazepine treatment or follow up drugs.
The institutions involved are:
• University of Virginia
• Medical University of South Carolina
• Children’s National Medical Center, Washington, DC
• University of Michigan
• University of Minnesota
• University of California, San Francisco
• Albert Einstein College of Medicine, Montefiore Medical Center
• National Institutes of Health, Bethesda
• St. George’s, University of London
• St. George’s University Hospitals NHS Foundation Trust
• ConfluenceStat, Orlando
• University of Central Florida College of Medicine
Source: Kapur et al. “Randomized Trial of Three Anticonvulsant Medications for Status Epilepticus,” New England Journal of Medicine, November 28, 2019.
This study was supported by the NINDS (U01NS088034, U01NS088023, U01NS056975, U01NS059041, and U01NS073476)
References
1 Chin RFM, Neville BGR, Scott RC. A systematic review of the epidemiology of status epilepticus. European Journal Of Neurology 2004;11(12):800-10.
2 Neligan A, Noyce AJ, Gosavi TD, et al. Change in Mortality of Generalized Convulsive Status Epilepticus in High-Income Countries Over Time: A Systematic Review and Meta-analysis. Jama Neurology 2019;76(8):897-905. doi: 10.1001/jamaneurol.2019.1268
3 Silbergleit R, Durkalski V, Lowenstein D, et al. Intramuscular versus intravenous therapy for prehospital status epilepticus. New England Journal of Medicine 2012;366(7):591-600. doi: 10.1056/NEJMoa1107494 [published Online First: 2012/02/18]
The Phase II clinical trial was led globally by a team at The Institute of Cancer Research, London, and The Royal Marsden Foundation Trust, and involved 258 men with advanced prostate cancer who had previously been treated and become resistant to androgen deprivation therapy and docetaxel chemotherapy.
The study has been published in the Journal of Clinical Oncology and was funded by the drug’s manufacturer Merck, Sharpe & Dohme.
Researchers found that a small proportion of men were ‘super responders’ and were alive and well even after the trial had ended despite having had a very poor prognosis before treatment.
The study found that one in 20 men with end-stage prostate cancer responded to the immunotherapy pembrolizumab – but although the number who benefited was small, these patients sometimes gained years of extra life.
The most dramatic responses came in patients whose tumours had mutations in genes involved in repairing DNA, and the researchers are investigating whether this group might especially benefit from immunotherapy.
Overall, 5% of men treated with pembrolizumab saw their tumours actually shrink or disappear, while a larger group of 19% had some evidence of tumour response with a decrease in prostate-specific antigen (PSA) level.
Among a group of 166 patients with particularly advanced disease and high levels of PSA, the average length of survival was 8.1 months with pembrolizumab.
Nine of these patients saw their disease disappear or partly disappear on scans. And of these, four were super-responders who remained on treatment at the end of study follow-up, with responses lasting for at least 22 months.
A second group of patients whose PSA levels were lower but whose disease had spread to the bone lived for an average of 14.1 months on pembrolizumab.
New larger trials are now under way to test whether men with DNA repair gene mutations in their tumours, or those whose cancer has spread to the bone, should receive pembrolizumab as part of their care.
The study also compared the effectiveness of pembrolizumab in men whose tumours had a protein called PD-L1 on the surface of their cancer cells and those whose tumours did not. Targeting PD-L1 activity with pembrolizumab takes the ‘brakes’ off the immune system, setting it free to attack cancer cells.
But the study found that testing for PD-L1 was not sufficient to tell which patients would respond to treatment. Men with PD-L1 in their tumours survived 9.5 months compared with 7.9 months for patients without PD-L1 in their tumours.
Identifying better tests to pick out who will respond best will be critical if pembrolizumab is to become a standard part of prostate cancer treatment.
Pembrolizumab was well tolerated, with 60% of patients reporting any side effects and only 15% of patients experiencing grade 3-5 side effects.
Professor Johann de Bono, Regius Professor of Cancer Research at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said: “Our study has shown that a small proportion of men with very advanced prostate cancer are super responders to immunotherapy and could live for at least two years and possibly considerably longer.
“We don’t see much activity from the immune system in prostate tumours, so many oncologists thought immunotherapy wouldn’t work for this cancer type. But our study shows that a small proportion of men with end-stage cancer do respond, and crucially that some of these men do very well indeed.
“We found that men with mutations in DNA repair genes respond especially well to immunotherapy, including two of my own patients who have now been on the drug for more than two years. I am now leading a larger-scale trial specifically for this group of patients and am excited to see the results.”
Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, said: “Immunotherapy has had tremendous benefits for some cancer patients and it’s fantastic news that even in prostate cancer, where we don’t see much immune activity, a proportion of men are responding well to treatment.
“A limitation with immunotherapy is that there’s no good test to pick out those who are most likely to respond. It’s encouraging to see testing for DNA repair mutations may identify some patients who are more likely to respond, and I’m keen to see how the new, larger trial in this group of patients plays out.”
25th November 2019
Results of the study, carried out with 82 participants, confirm that both palm and finger temperature increase significantly in patients with rheumatoid arthritis (RA).
RA patients were examined by two rheumatologists. A subset of these participants underwent diagnostic ultrasonography by a trained rheumatologist in order to ensure that the recruited participants had no active signs of synovitis in their hands and wrists.
Dr Alfred Gatt, from the University of Malta and a Visiting Fellow at Staffordshire University, was lead author of the report. He explained “We used Flir T630 therma camera and followed the guidelines of the American Thermology Association.
“The results of our study show that the two probability curves intersect at 31.5 for palm temperatures, indicating that individuals whose palm temperatures is less than 31.5% are more likely to be healthy; while those persons whose palm temperature is less than 31.5 are more likely to have rheumatoid arthritis. Similarly, for finger temperatures, the two probability curves intersect at 30.3%.”
“While ultrasonography had not detected any significant changes in our study population, thermography flagged a possible ongoing disease process by reporting these higher temperatures“.
“We hypothesise that this temperature difference may be attributed to underlying subclinical disease activity or else that the original inflammatory process may cause irreversible thermal changes that persist after the disease activity has resolved. We will need further studies to substantiate this.”
Dr Gatt added: “Thermal imaging is an emerging technology within medicine and has the potential to become an important clinical tool as disease processes can vary the magnitude and pattern of emitted heat in a person with rheumatoid arthritis.”
Associate Professor Cynthia Formosa, also from the University of Malta and Visiting Fellow at Staffordshire University, said: “This is the first study to explore thermographic patterns of patients with rheumatoid arthritis comparing them to healthy controls. Our results have clearly shown that an RA hand without active synovitis [the medical term for inflammation of the synovial membrane] exhibits higher temperatures when compared to healthy individuals.”
Professor Nachi Chockalingam, Director of Centre for Biomechanics and Rehabilitation Technologies at Staffordshire University co-authored the study. He added: “Rheumatoid arthritis affects more than 400,000 adults in the UK which can lead to deformity, disability and cardio-vascular problems. Timely detection of ongoing synovitis in RA is of paramount important to help enable tight disease control. However we know RA can be difficult to diagnose.”
“This work showcases our successful collaboration with colleagues in Malta and the potential thermal imaging has in helping practitioners to assess the disease. In addition to making some seminal scientific contributions, our collaborative research work informs our curriculum development and teaching.”
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