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25th September 2020
In this new study by a team from the Division of Rheumatology, New York University School of Medicine, the authors speculated that patients with inflammatory arthritis (IA), prescribed immunosuppressants may be protected to some extent against the worse outcomes for COVID-19, that is, the need for hospitalisation and/or mechanical ventilation. They recruited patients with a range of IA including rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ankylosing spondylitis or inflammatory bowel disease-associated arthritis. All patients had either confirmed COVID-19 (based on a positive test result) or were strongly suspected of being infected, based on having a new fever or known positive contact plus one or more respiratory symptoms.
Findings
A total of 103 patients, of whom 80 had confirmed COVID-19 infection were included in the analysis. All were followed for a mean of 42 days from the time of symptom onset which was established through a series of on-line questionnaires, telephone calls or a review of medical records and hospital charts. The mean age of participants was 53 years (72% women) and in terms of their disease state prior to the onset of COVID-19, nearly a quarter (23%) said that their disease was in remission and 38% stated that they had mild and 34% moderate disease severity with the remainder having severe disease. Overall, 26% of patients required hospitalisation due to COVID-19 and 4% (4/103) of patient died. Interestingly, chronic use of corticosteroids was significantly more common among those hospitalised (37% vs 4%, p < 0.001) compared to those on maintenance anti-cytokine therapies. In addition, older patients with comorbidities such as hypertension, were more likely to be hospitalised.
In conclusion, the authors called for further studies to determine whether immunomodulatory therapy can prevent COVID-19 or ameliorate its clinical outcomes.
Reference
Haberman RH et al. COVID-19 in patients with inflammatory arthritis: a prospective study on the effects of comorbidities and DMARDS on clinical outcomes. Arthritis Rheumatol 2020; doi: 10.1002/ART.41456
18th September 2020
The results showed an improvement in disease severity and for their latest study, the team further tested the treatment in 15 children, with a mean age of 9 years (range 3-16) in an open label study. The live R. mucosa was grown for up to 48 hours and freeze-dried in a 3-ml self-contained spray system. Participant parents were provided with 1.5ml of sterile water and for each dose, the water added to the bacteria and the resultant mixture sprayed onto affected areas of skin. All the participants were treated with live R. mucosa twice weekly for a period of 3 months and then on alternate days for an additional four weeks, followed by a 4-12 month washout period. The primary disease severity outcome of interest was a SCORAD50 (that is, a 50% improvement in their SCORAD score) whereas a secondary disease severity outcome was an EASI50.
Findings
After 16 weeks, 85% (17/20) of children achieved the primary outcome (SCORAD50) and 90% met the secondary outcome of an EASI50 and this was observed at all affected sites. Moreover, improvements were similar in patients with both mild and moderate disease severity and the improvements persisted for at least 8 months after cessation of therapy. The authors concluded that these preliminary findings now warranted a placebo-controlled trial to fully investigate the value of the treatment.
Reference
Myles IA et al. Therapeutic responses to Roseomonas mucosa in atopic dermatitis may involve lipid-mediated TNF-related epithelial repair. Sci Transl Med 2020; Sept 9th eaaz8631. doi: 10.1126/scitranslmed.aaz8631.
However, the COVID-19 pandemic has resulted in a cessation of screening programmes. But what has been the impact of this change?
In this recently published study, an Italian team from the University of Bologna, sought to model the effect of time-delays in access to colonoscopy and estimated the potential effect on mortality from such delays. In trying to understand the impact, the team undertook a literature review to provide an estimate of the proportion of CRC cases by stage, which were detected via screening. Due to the heterogeneity of the studies identified, the team used four categories of delay times (0-3 months, 4-6 months, 7-12 months and longer than 12 months).
Findings
With a delay of 0-3 months, 74% of CRC cases would be expected to be in stages I to II although longer delays of 4-6 months, would result in a non-significant increase in cases. In contrast, it was estimated that a moderate delay of 7-12 months would result in a significant increase in the incidence of advanced CRC cases, 29% to 33%, (p < 0.001). Furthermore, the model predicted a 12% increase in deaths if the delay increased to longer than 12 months. In summarising their findings, the authors noted that a delay of 4-6 months was acceptable and unlikely to have a significant impact on screening. However, the backlog from delays lasting over 6 months would lead to a higher number of advanced stage CRCs being detected and delays over 12 months would significantly increase CRC mortality. They called for screening-only, COVID-19 free dedicated facilities in the event of a further lockdown.
Reference
Ricciardiello L et al. Impact of SARS-CoV-2 pandemic on colorectal cancer screening delay: effect on stage shift and increased mortality. Clin Gastroenterol Hepatol 2020: doi: 10.1016/j.cgh.2020.09.008
The provision of peer support, that is, other patients with the same chronic illness, has been shown in the short-term (up to 6 months) to help facilitate good patient outcomes among those with type 2 diabetes although little is known about the longer term impact of this intervention.
For this new study, researchers from Perelman School of Medicine, University of Pennsylvania, assessed the effect on disease outcomes of peer support for a period 12 months. They conducted a randomised controlled trial in two phases. In the first phase, patients with type 2 diabetes and poor glycaemic control (defined as a glycated haemoglobin (HbA1C) level of greater than 8% on at least two occasions over the previous 24 months, were randomised to either mentoring from peers with well-controlled diabetes or usual care. In phase 2 of the trial, different patients with poor glycaemic control, were randomised to mentoring from those who were mentees in phase 1 or usual care. The prespecified primary outcome as the change in HbA1C from baseline to 6 months and secondary outcomes included change in HbA1C from baseline to 12 months and changes from 6 – 12 months in LDL cholesterol levels, blood pressure and quality of life.
Findings
A total of 487 patients were enrolled in the study; 365 into phase 1 and 122 into phase 2. After 6 months, the mean change in HbA1C was -0.20% in the usual care versus -0.52% in the mentor group (p = 0.06). Furthermore, there were no differences between groups in HbA1C levels after 12 months and the intervention (that is, mentor group) did not affect blood pressure, LDL cholesterol levels or quality of life. Equally, there were no significant differences between groups during phase 2. The authors called for future studies to examine how best to facilitate mentor and mentee engagement to improve disease outcomes.
Reference
Long JA et al. Effect of peer mentors in diabetes self-management vs usual care on outcomes in US veterans with Type 2 diabetes: A randomized clinical trial. JAMA Netw Open 2020;3(9):e2016369. doi:10.1001/jamanetworkopen.2020.16369
10th September 2020
Professor Axel Dignass, president of United European Gastroenterology, discusses the current state-of-play for the treatment and care of inflammatory bowel disease (IBD), highlighting the key developments and routes to achieving successful patient outcomes.
Inflammatory bowel diseases, or IBD, are chronic disorders of the gut and include Crohn’s disease (CD) and ulcerative colitis (UC). The primary symptoms of IBD include abdominal pain, cramping, diarrhoea, urgency, weight loss, rectal bleeding and fatigue. In addition to these main symptoms, around 25–40% of IBD patients may experience other more non-specific symptoms in the eyes, joints, bones, skin, kidney and liver as well as conditions like anaemia. The causes of IBD are still unknown; however, it is thought that a genetic predisposition and environmental factors impact the likelihood of being diagnosed with IBD.
The prevalence of IBD is increasing worldwide.1 In Europe it is estimated that between 2.5–3 million people have IBD.2 IBD has also started impacting a much younger population and there has been a rise in the number of children being diagnosed, with up to 20% of cases developing in childhood.2 In Europe that equates to over half a million children. This general rise is particularly prominent in urbanised and developed countries, which has largely been attributed to a westernised lifestyle as well as a number of associated environmental factors.1
There is currently no known cure for IBD and treatment is aimed at minimising the impact of the condition and achieving symptomatic long-term remission. The effectiveness of treatments vary from case to case as there is no one treatment that works for all patients. Increased knowledge of IBD has resulted in the development of new treatments, medications and approaches. For example, there is a growing importance attributed to mucosal healing, particularly in paediatric patients where the enhancement of growth and bone formation is so key.
More advanced biological treatments, such as anti-TNF antibodies, anti-IL12/IL23 antibodies and anti-integrin antibodies, have been sought to help with this process. Other new and promising medications are also being developed, including various anti-IL23 antibodies, new anti-adhesion molecules, JAK inhibitors and SP1-receptor inhibitors, to improve patient experiences and outcomes.
Moreover, our growing understanding of nutritional therapy and identification of predictors of response to medications are allowing for increasingly personalised treatment plans.
Alongside these clinical developments, a number of approaches to make IBD treatment more all-inclusive have been central to securing more positive patient outcomes.
The ‘treat-to-target’ or T2T management approach has been deployed to assist with underlying inflammation, minimise how active the disease is during the early stages of IBD, act as a preventative measure for disease progression and help to improve the long-term outcomes for the patient. It also aims to reduce the risk of complications such as the development of strictures, fistula, functional impairment, or dysplasia.
T2T management requires a collaborative approach from both the clinician and the patient. The process involves identifying an appropriate target, selecting initial treatment according to the risk of disease progression, measuring the general characteristics of the disease, monitoring progress (tight control), and optimising therapy and care to achieve positive clinical outcomes.
A key part of T2T is consultation with the patient to fully understand their specific needs. This involves setting predefined treatment targets with the patient, initiating appropriate and early treatment according to the risk of disease progression (early intervention), continuously monitoring disease activity (tight control), and modifying treatments until the original targets have been met. This engagement with the patient is particularly important amongst paediatric patients where non-compliance with the recommended treatment plan is common.
As with all IBD treatments, to achieve optimal patient outcomes from the T2T approach it is paramount that the patient is monitored by a multidisciplinary team. This team should comprise clinicians, advanced practice providers, nurses, allied health professionals (AHPs), psychologists and dieticians among other HCPs. Once established, a multidisciplinary team should meet regularly to discuss the management of an IBD patient and ensure support is coordinated correctly.
A multidisciplinary team is critical to outcomes as the needs of IBD patients, particularly paediatric patients, are often both complex and highly individual, requiring a personalised treatment plan. Over and above the physical implications of IBD, the indirect and invisible costs of the condition are significant and should form an integral part of the treatment plan.
Multiple studies have demonstrated that the burden of IBD can negatively impact education, work and social life, both as a result of the psychological impacts as well as through forced absences caused by events such as flare-ups and treatments.1,3,4,5
Such an integrated and coordinated approach to care for IBD patients may prove challenging to healthcare systems, particularly with the prevalence of IBD on the rise. It is however a necessary step in securing optimal, effective and cost-efficient care for IBD patients moving forward.
Another increasingly important consideration in the treatment and care of IBD patients is patient-reported outcomes (PROs), which reflect a wider trend to place the patient at the centre of condition management. PROs incorporate outcomes and experiences that may not necessarily be obvious to the clinician but are very important to a patient, and imperative to their treatment plan and management.
Thus, it is not surprising that the attitudes of patients and physicians about disease burden, treatment targets and treatment options vary significantly. In relation to IBD specifically, only the patient will be aware whether or not they are feeling fatigue and pain, or whether they have blood in their stools. Yet as primary symptoms of IBD and flare-ups, these PROs form a central part of the treatment process.
To maximise patient outcomes across Europe there is a need to continue improvements in the treatment and care of IBD patients. This will help to ensure that sustainable, efficient and cost-effective services are delivered into the future to those who need it most. However, we also need to be mindful that many countries do not have the resources or capacity to deliver optimal levels of treatment, and this must change if we are to truly maximise outcomes in IBD patients.
Axel Dignass MD PhD
President of UEG and director, department of Medicine, Agaplesion Markus Hospital, Goethe–University Frankfurt am Main, Germany
8th September 2020
The study by a team from the Boston School of Public Health, Massachusetts, used two population-based surveys of US adults aged 18 years and over.
During the current pandemic, data were obtained using the COVID-19 and life stressors impact on mental health and well-being (CLIMB) questionnaire conducted during March and April 2020 and the national health and nutrition survey (NHANES) conducted from 2017 to 2018 and both questionnaires included a validated measure of depression, the patient health questionnaire-9. A total of 1441 adults completed the CLIMB and 5065 completed the NHANES. Combining the data showed that 8.5% of adults had depression prior to COVID-19 and this increased to 27.8% during the pandemic. In addition, the prevalence of mild depression increased during the pandemic (24.6% vs 16.2%) as did the prevalence of severe depression (5.1% vs 0.7%). Interestingly, a higher incidence of depression during the pandemic was associated with lower income, lower savings and exposure to more stressors, for example, job loss.
The authors concluded that since the burden is greatest among socially marginalised groups, more resources should be directed towards supporting these groups.
Reference
Ettman CK et al. Prevalence of depression symptoms in US adults before and during the COVID-19 pandemic. JAMA Netw Open 2020;3(9):e 2019686.
This is the conclusion of a new analysis by an international team of researchers, of data contained in two disease registries, COVID-Hep (based in the UK) and SECURE-Cirrhosis (based in the US).
For the study, the team collected information on 151 recipients from 18 countries, with a median age of 60 years (32% women) and compared the outcomes with a control group of 627 (median age 73 years, 48% women) non-transplant patients. The major outcome of interest was death although the researchers also examined rates of intensive care admission. A similar number of patients were hospitalised (82% vs 76%, transplant vs control group) although a higher proportion of transplant patients were admitted to intensive care (28% vs 8%, p < 0.0001) and given intensive ventilation (20% vs 5%, p < 0.0001).
However, the proportion of patients dying was lower in the transplant group (19% vs 27%, p = 0.046) and none of the deaths were liver-related. Further analysis revealed that age, serum creatinine levels and non-liver cancer were associated with an increased risk of death among transplant patients.
The authors concluded factors such as age and co-morbidities were more important predictors of mortality than transplantation.
Reference
Webb GJ et al. Outcomes following SARS-CoV-2 infection in liver transplant recipients: an international registry study. Lancet Gastroenterol Hepatol 2020; August 28: https://doi.org/10.1016/ S2468-1253(20)30271-5
7th September 2020
The authors, from the Georgia Department of Public Health, describe COVID-19 spread in an overnight camp in which there were 597 residents, consisting of both campers, trainees and staff members staying in cabins, which housed between 3 and 26 people. The median age of campers was 12 years, whereas the median age of staff members and trainees was 17 years. One teenage staff member left the camp after developing chills and tested positive for COVID-19. Tests were then performed on all camp members and data were available for 344 (58%) of those in attendance. Among these, 260 (76%) tested positive and the authors calculated an overall attack rate (that is, positive cases/total attendees) of 44%. However, this rate was 51% among those aged 6 – 10 years and 33% among those aged 18 – 21. Among 136 cases where symptom data was recorded, 36 individuals (26%) reported no symptoms.
The authors highlight how quickly infection spread in an overnight setting, despite the use of cloth masks and opening of windows and doors in buildings. They also noted that asymptomatic spreading together with singing, cheering and a large number of individuals sleeping in the same cabin, were likely reasons for the rapid spread of the virus.
Reference
Szablewski CM et al. SARS-CoV-2 Transmission and infection among attendees of an overnight camp — Georgia, June 2020. MMWR / August 7, 2020 / Vol. 69 / No. 31
31st August 2020
These are the conclusions from a new study by a team from the Department of Oncology-Pathology, Karolinska Institute, Sweden, which sought to evaluate three different AI computer-aided detection (CAD) algorithms for mammography assessment without radiographer intervention.
The study included a sample of 8805 women of whom 739 had a diagnosis of breast cancer and a random sample of 8066 healthy controls. Each of the three CAD systems processed the mammogram images and yielded a prediction score for each breast based on the suspicion of cancer, ranging from 0 (no cancer) to 1 (high suspicion). The authors then compared the predictive accuracy of each CAD with those of a radiologist. The overall results across the three CAD algorithms showed a sensitivity of 86.7% and a specificity of 92.5%. However, the performance of one CAD algorithm surpassed the performance of radiologists and was better at detecting cancer than the other two. The highest performing CAD algorithm had an area under the curve of 0.956 for detecting cancer at screening or within 12 months thereafter.
In their conclusion, the authors noted that the best performing CAD was on a par with a radiologist and called for further evaluations of AI CAD systems as independent readers in mammography screening programs.
Reference
Salim M et al. External evaluation of 3 commercial artificial intelligence algorithms for independent assessment of screening mammograms. JAMA Oncol doi:10.1001/jamaoncol.2020.3321
Researchers from the Division of Pulmonary Medicine, UMPC Children’s Hospital, Pittsburgh, recruited 192 children with a mean age of 9.8 years who were randomised to either daily capsules containing 4000IU of vitamin D3 plus inhaled fluticasone 88mcg twice daily (for children under 12 years of age) or 110mcg twice daily or placebo and fluticasone.
After randomisation, the children were followed for 48 weeks with the primary outcome being time to a severe asthma exacerbation, defined as the occurrence of either use of systemic corticosteroids for at least three days or hospitalisation or an emergency department visit because of asthma that required systemic steroids. While mean baseline vitamin D levels were not particularly low (approximately 22ng/ml), at the study end, 87.2% in the vitamin D group compared with 30.1% in the placebo group, achieved an acceptable plasma vitamin D levels (30ng/ml). The time to a severe exacerbation was 240 days in the vitamin D group and 253 days in the placebo group (p = 0.63).
The authors concluded that among children with persistent asthma and low vitamin D levels, supplementation it of little value.
Reference
Forno E et al. Effect of vitamin D3 supplementation on severe asthma exacerbations in children with asthma and low vitamin D levels The VDKA Randomized Clinical Trial. JAMA 2020;324(8):752–60.
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