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

Women affected most by vascular complications of diabetes

14th November 2019

A paper published on World Diabetes Day in the European Journal of Preventive Cardiology reports that women are most affected by the vascular complications of diabetes.

Globally, there are more deaths due to diabetes in women than in men (2.1 versus 1.8 million annually) – this excess risk is mainly due to the higher risk of cardiovascular death in women.

Coronary heart disease is the most frequently reported form of cardiovascular disease and the most lethal one. Women with diabetes are at a 1.81-fold risk of death from coronary heart disease compared to women without diabetes. Men with diabetes have a 1.48-fold risk of death from coronary heart disease compared to men without diabetes.

Peripheral artery disease – which can ultimately lead to foot amputation – is the most common initial manifestation of cardiovascular disease in patients with type 2 diabetes. Its prevalence is 1.8-fold higher in women compared to men.

Heart failure is the second most common initial manifestation of cardiovascular disease in type 2 diabetes. Women with diabetes are five times more likely to get heart failure than women without diabetes. Men with diabetes are two times more likely to get heart failure than men without diabetes.

Research is ongoing to explain these differences between women and men. One possible reason for the higher heart failure risk could be that a specific form is more common in women generally and is the type most likely to affect patients with diabetes. This form is called heart failure with preserved ejection fraction, where the heart maintains its pump function but has increased stiffness causing impaired relaxation after contraction.

In both women and men, a healthy lifestyle is the cornerstone to preventing diabetes; once people have diabetes, it is fundamental to stopping the cardiovascular complications.

Senior author Professor Joline Beulens, of Amsterdam University Medical Centre, the Netherlands said: “With the increased levels of obesity in our society we have seen an enormous rise in the prevalence of diabetes. We know that type 2 diabetes is a lifestyle-related disease, so we can halt the trajectory with better behaviours.”

Lifestyle management is the first line of treatment for patients with diabetes,” continued Professor Beulens. “If lifestyle doesn’t sufficiently control glucose levels and the risk of complications, then glucose-lowering treatment should be initiated as the second line of therapy.”

Professor Beulens said: “Patients with diabetes remain at significantly higher cardiovascular risk compared to people without diabetes. There is an urgent need to better identify, monitor, and control diabetes to prevent the devastating cardiovascular complications.”

International survey shows a lack of knowledge about risk factors for type 2 diabetes

Merck has released the results of research that has shown a lack of knowledge about the risk factors associated with type 2 diabetes internationally.

More than half (56%) of the respondents are not aware the condition may be preventable and 41% are unaware of the steps that can be taken to prevent or delay the development of the condition. Over 450 million people worldwide are currently living with diabetes and it is believed that one in two are undiagnosed. The majority of these cases are type 2 diabetes, which can be prevented or delayed through a number of lifestyle factors and medication. The results of this survey demonstrate a great unmet need for education on preventing or delaying type 2 diabetes.

Further insights show almost half (46%) of respondents across all countries are either unaware (30%) or unsure (16%) that having a family member with diabetes increases the risk of developing the condition. Under a third (29%) believe signs and symptoms of early stage diabetes can be observed, whereas it normally has no signs and symptoms and can only be diagnosed with lab tests.

The results of this international survey demonstrate that more needs to be done to raise awareness of diabetes and its causes. With close to 700 million people predicted to develop type 2 diabetes by 2045, we need to act now to address prediabetes and help prevent a disease that can cause many long-term and permanent complications for people. We know that type 2 diabetes can, in many cases, be delayed or prevented, which is why it is crucial that we continue to educate people about the risk factors and the lifestyle changes that can really make a difference” said Francois Feig, Head of General Medicine & Endocrinology, Merck.

Merck and the International Diabetes Federation, the coordinator of World Diabetes Day, are strong collaborators towards their shared goal of advocating for diabetes care and prevention worldwide.

Commenting on the survey’s findings, Prof Nam Cho, President at International Diabetes Federation, said: “The results of this survey are timely and important. Diabetes is a leading cause of blindness in the working-age population, lower-limb amputation, cardiovascular disease and kidney failure. Early death and type 2 diabetes is on the rise in most countries. However, simple action can help to reduce the risk of developing the condition. There is evidence that type 2 diabetes is preventable, which is why, this World Diabetes Day, we are focusing on families. If we can raise awareness and help people better understand their, and their family’s risk, we can hopefully prevent more people from developing type 2 diabetes.”

The survey was undertaken for Merck by YouGov between 14-22 October 2019. A total of 9350 adults in nine countries (Brazil, Mexico, Russia, UAE, Malaysia, Vietnam, China, Saudi Arabia, Chile) participated in the survey.

World Diabetes Day sees launch of landmark drug trial

On World Diabetes Day, researchers from the University of Glasgow are eagerly anticipating the initiation of a pioneering new global trial.

The TTT1 trial – funded by JDRF, the leading global organisation funding type 1 diabetes research, and co-led by State University of New York – will begin in Scotland in early 2020 and aims to help the overwhelming number of individuals with the condition for whom blood glucose is still not controlled to target levels, despite improvements in technology including insulin pumps and continuous glucose monitoring.

The TTT-1 trial is led by the University of Glasgow’s global leader in the treatment of type 1 diabetes, Dr John Petrie, Professor of Diabetic Medicine. The trial aims to address a gap in current diabetes treatment, which sees a majority of people on insulin therapy with HbA1c above the recommended target of 7%, indicating high blood glucose over the previous two to three months.

The trial will assess a new combination therapy with insulin, balancing the effects of two drugs called dapagliflozin and semaglutide.

Dapagliflozin (Forxiga), as well as a drug related to semaglutide called liraglutide (Victoza), can improve control in adults with type 1 diabetes. Dapagliflozin has recently been approved for this purpose in the UK and Europe; however, neither drug alone consistently gets most people with type 1 diabetes to the recommended target HbA1c.

Professor Petrie said: “The hope is to use the combination therapy of dapagliflozin and semaglutide to reduce HbA1c to less than 7% in the majority of people with type 1 diabetes; and since these drugs have benefits for the heart and can also induce weight loss, there may be additional advantages of this drug combination, which would be very positive for those with the condition.

In addition, both dapagliflozin and semaglutide are likely to reduce unpredictable fluctuations in blood glucose levels, thus providing a greater sense of security for people with type 1 diabetes, substantially improving quality of life.”

Rachel Connor, Director of Research Partnerships at JDRF, said: “Type 1 diabetes is a really challenging condition to manage, and the limitations of the tools we have today, both technologies and medicines, mean that many people living with the condition struggle to achieve the glucose management targets recommended by doctors.

We’re proud to support the TTT1 trial and are hopeful that this will lead to a new way to help people with type 1 reduce HbA1c and so also reduce their risk of developing long term complications.”

Improving cardiac surgery benefits through key research

12th November 2019

Over 35,000 adults undergo cardiac surgery in the UK every year with a further 1 million worldwide.

While short-term results of surgery are excellent, many patients fail to obtain long-term benefits the reasons for which remain unclear. Academics from the University of Leicester are researching why this is and have defined the top priorities for UK cardiac surgery research.

The Leicester team have worked with the James Lind Alliance, a non-profit making initiative that brings patients, carers and clinicians together in Priority Setting Partnerships to identify and prioritise the top 10 unanswered research questions or evidence uncertainties.

Funded by Heart Research UK, the Adult Cardiac Surgery Priority Setting Partnership brought together patients, carers, nurses, doctors, pharmacists, organisations such as the Leicester Centre for Black and Minority Ethnic Health. With an independent chairperson appointed by the James Lind Alliance, the team used a Delphi approach to identify the top 21 priorities from over 1000 topics identified in an international survey launched in 2018.

Professor Gavin Murphy, British Heart Foundation Chair of Cardiac Surgery and Director of Leicester Clinical Trials Unit who leads the Leicester team said: “This work, which represents the needs of patients, will enable all stakeholders to focus their efforts at addressing the research priorities that we have identified.

This approach means that we are more likely to effect change through our research that will benefit patients and the health service.”

Kate Bratt-Farrar, Chief Executive of Heart Research UK, said: “Setting priorities is vital to ensure that medical research is advancing in the right areas. A project like this puts the people affected by heart conditions at the forefront of that process and provides a valuable link between researchers and clinicians in laboratories.

Heart Research UK has a long history of funding pioneering medical research, and we are proud to once again be at the cutting edge, working with patients to steer the future of cardiac surgery.

We know research works, and it is through innovative projects like the PSP that we can reach the next breakthroughs and keep those we love around for longer.”

The Top 10 priorities are:

1) Quality of life: How does a patient’s quality of life change (e.g. disability-free survival) following heart surgery and what factors are associated with this?

2) Frailty: How can we address frailty and improve the management of frail patients in heart surgery?

3) Chronic conditions: How can we improve the outcomes of heart surgery patients with chronic conditions (obesity, diabetes, hypertension, renal failure, autoimmune diseases etc.)?

4) Prehabilitation: Does prehabilitation (a programme of nutritional, exercise and psychological interventions before surgery) benefit heart surgery patients?

5) Heart valve intervention: When should heart valve intervention occur for patients without symptoms?

6) Surgical methods: How does minimally invasive heart surgery compare to traditional open surgery?

7) Organ damage: How do we minimise damage to organs from the heart-lung machine/heart surgery (heart, kidney, lung, brain and gut)?

8) 3D Bioprinting: Can we use 3D bio-printing or stem cell technology to create living tissues (heart valves/heart) and repair failing hearts (myocardial regeneration)?

9) Atrial fibrillation: What are the most effective ways of preventing and treating post-operative atrial fibrillation?

10) Infection: How do we reduce and manage infections after heart surgery including surgical site/sternal wound infection and pneumonia?

A final workshop that included patients, carers and medics, chaired by independent moderators, with key stakeholders attending as observers, selected the Top 10. The results of this process and a plan for translating these priorities into research studies are published today.

To help implement this plan Heart Research UK and the British Heart Foundation Clinical Research Collaborative will invite clinicians, leading researchers, and members of the public, to a National Cardiac Surgery Research Workshop in June 2020. This will keep patients and carers at the centre of the national research programme, and increase the likelihood that the PSP priorities are addressed by research of the highest quality.

Digital hospitals wired for triple success

Cambridge University Hospitals NHS Foundation Trust in the UK has scored a hat-trick for being so IT savvy.

For the third year running, Addenbrooke’s Hospital and the Rosie Hospital have been internationally “recognised” for using technology to improve clinical quality, safety and outcomes.

The Trust scored a Level 7 of 10 ‘Special Recognition’ certification in the prestigious international Most Wired survey run by the College of Healthcare Information Management Executives (CHIME) – narrowly missing out on a Level 8.

The survey benchmarks digital adoption and outcomes, focussing on electronic patient records, IT support, security, business management, data and analytics, and connections with other healthcare organisations.

Most Wired Certified Level 7 and 8 organisations are defined as “deploying technologies and strategies to help them analyse their data and starting to achieve meaningful clinical and efficiency outcomes.”

CUH was the only health organisation in Europe, and one of only two organisations outside of the USA, recognised during a ceremony at the Chime Fall Forum in Arizona USA on 6 November 2019.

CUH Chief Clinical Information Officer and Renal Consultant, Dr Afzal Chaudhry, said: “Taking part in this international survey allows us to benchmark ourselves against elite healthcare organisations across the world, where many, particularly those in the USA, have been implementing and adopting healthcare technology for many more years than us.

To be ranked among these elite organisations demonstrates the remarkable progress that we have made, and are continuing to make, through our advancements in the use of digital technology.”

CUH executive director of improvement and transformation, Dr Ewen Cameron, added: “This is a fantastic achievement, which again showcases the clinical and digital collaboration across our hospitals over the past five years to create an internationally recognised digital centre of excellence to benefit our patients.”

Simple blood test could better predict both kidney disease and cardiovascular risk

Researchers have found a better way to test for kidney disease using a simple blood test that is affordable and although it is available in NHS laboratories is not yet widely used.

In a study, published in the journal Nature Medicine and led by the University of Glasgow, researchers have highlighted that a simple blood test – which could easily be adopted routinely in the NHS – is a better way of measuring both kidney and cardiovascular disease risk, as it offers a more precise diagnosis and could lead to better patient outcomes.

Amongst patients with chronic kidney disease reducing the risk of cardiovascular disease relies on accurate diagnosis, recognition of risk and early identification and treatment of risk factors.

Dr Jennifer Lees, from the University of Glasgow’s Institute of Cardiovascular and Medical Sciences, said: “Our study emphasises how important renal function is for our general health, given that suboptimal renal function can lead to an increased risk of a cardiovascular event.

“Our findings indicate that patients would benefit from the added predictive value of using a test called the cystatin C test. We would hope to see it adopted as the primary method for diagnosis of chronic kidney disease – particularly for those patients with cardiovascular disease risk factors such as diabetes, hypertension or obesity.”

Paddy Mark, Professor of Nephrology, added: “For a relatively low cost – about £2.50 per test – doctors can use this test to gain a much clearer understanding of a patient’s kidney health, as well as cardiovascular risk. With this knowledge, doctors can identify and treat risk factors earlier and, hopefully, save more lives in the process.”

The study used data from over 400,000 patients in the UK Biobank and looked at three different kidney function tests for eGFR – estimated glomerular filtration rate – to determine which was the most clinically informative for predicting cardiovascular disease and mortality.

Using statistical models to compare the results, the researchers determined the cystatin C formula to be the best at predicting cardiovascular risk as compared to the traditionally-used serum creatinine method.

Cystatin C testing has been available in the NHS for over 10 years, and has a number of potential advantages over serum creatinine and is thought to be a more sensitive measure to estimate kidney function. However, cystatin C is around 10 times more expensive than serum creatinine at £2.50 per test, compared with £0.25 for serum creatinine. Currently cystatin c is only used in highly specialised settings and is not available in all hospitals.

Dr Lees added: “Despite being recommended by the National Institute for Health and Care Excellence (NICE), measurement of cystatin C has not been widely adopted in clinical practice, presumably relating to uncertainty around the added value of a more expensive test.

“We hope our study shows that the adoption of this simple test would provide doctors with a precision medicine diagnosis for kidney disease and cardiovascular risk.”

The study, ‘Glomerular filtration rate by differing measures, albuminuria and prediction of cardiovascular disease, mortality and end-stage kidney disease’, was funded by Chest, Heart and Stroke Association Scotland, The British Heart Foundation and Kidney Research UK.

Biologics offer similar disease activity improvement for elderly- and young-onset RA patients

Patients with rheumatoid arthritis whose disease onset occurred at an older age and those whose disease onset occurred earlier in life have similar improvements in clinical disease at 48 weeks after starting biologics.

Patients with elderly-onset RA could present with higher disease activities and increased disabilities as compared to those with young-onset RA. Despite this, previous studies showed elderly patients receive biologics less frequently than younger individuals, suggesting patients with elderly-onset RA are potently undertreated,” says Sadao Jinno, MD, MSc, instructor of rheumatology at Kobe University School of Medicine and the study’s lead author. “On the other hand, in our daily practice, we have seen many elderly-onset RA patients treated with biologics effectively and safely. We wanted to investigate if there are differences in efficacy and safety of biologics between the two age groups.”

Researchers in Japan conducted the study with 7183 patients with RA who were age 18 or older and enrolled in a Japanese multicentre observational registry between September 2009 and December 2017. The patients also had to have a 3.2 or higher on the Disease Activity Score in 28 joints (DAS-28) and erythrocyte sedimentation rate measurement when they started biologics.

They assessed the relationship between age of RA onset and the clinical effectiveness of therapy at 48 weeks. The primary outcome for the study was a Clinical Disease Activity Index (CDAI) score at 48 weeks. Secondary outcomes included biologic retention at 48 weeks, achievement of a clinical disease activity index remission and low disease activity, or remission.

Among the patients on biologics, there were less in the elderly-onset RA group compared to the young-onset RA group. Of 989 patients who initiated biologics, 364 (37%) were elderly-onset. After adjusting for differences in baseline characteristics between the two age groups, researchers found no significant differences in the CDAI scores at 48 weeks. They did find a trend toward lower index remission rates in the elderly-onset group, but low disease activity/remission rates were similar between the two groups.

Our findings showed there were no significant differences in Clinical Disease Activity Index scores at 48 weeks between elderly-onset and young-onset RA, suggesting biologics can be used for those with elderly-onset RA as effectively as for those with young-onset RA. We also found there was no difference of adverse event discontinuation rates between the two groups,” says Dr. Jinno. “Clinicians should choose wisely which patients with elderly-onset RA are safely treated with biologics given that they are still at risk of developing adverse events, especially infections. Next, we plan to investigate if patients with elderly-onset RA respond differently to various modes of biologics.”

Atmospheric and environmental changes impact lupus flares

Research presented at the 2019 ACR/ARP Meeting shows a strong association between changes in atmospheric and environmental variables 10 days before a clinic visit and organ-specific lupus flares in patients with SLE.

Knowledge of the role environmental exposures play in the development of SLE and their association to SLE activity might help rheumatologists identify modifiable risk factors and mechanisms that give rise to lupus, according to the authors of this study. They examined how changes in fine particulate matter (PM2.5) concentration, ozone concentration, temperature, resultant wind, relative humidity and barometric pressure may predict organ-specific lupus flares.

Recent genome-wide association studies have identified more than 40 single nucleotide polymorphisms, which are important in lupus. Single nucleotide polymorphisms are the most common type of genetic variation among people but a relatively low percentage of people who have these genetic variations actually develop lupus, suggesting that environmental factors play an important role in lupus says George Stojan, MD, Assistant Professor of Medicine, Johns Hopkins Lupus Center, and the study’s lead author. “There is strong epidemiologic evidence of association with several environmental factors, including crystalline silica exposure, cigarette smoking, and exogenous estrogens as well as potential associations between other exogenous factors such as mercury, ultraviolet radiation, solvents and pesticides.

When it comes to atmospheric impact, data from the Hopkins Lupus Center previously described significant seasonal variation in SLE disease activity with more arthritis activity in the spring and summer months, and an increase in renal activity in winter months, significantly higher anti-dsDNA antibody titers in the fall, and a significant variation of global disease activity through the year. While several studies in the past attempted to correlate global SLE disease activity with atmospheric changes, this is the first study looking at the association of organ specific lupus flares with atmospheric changes prior to patient visits.”

The study included 1628 patients who fulfilled four of the 11 ACR or SLICC classification criteria for SLE. The data ranged from 1999 to 2017. The maximum span between visits was 110 days with one-month time aggregation units. Disease activity was expressed as Physician Global Assessment (PGA) taken at every patient visit. Lupus flare was defined as a PGA score increase of one point or more compared to the previous visit.

Environmental and atmospheric data was obtained from the US Environmental Protection Agency (EPA), including PM2.5 and ozone concentration, temperature, residual wind, relative humidity and barometric pressure. The researchers calculated the average values of each factor 10 days prior to patient visit. They also built univariate and multivariate models to study the association of the variables with lupus disease activity. They adjusted the models for age, sex, income, racial distribution, and rural versus urban residence. They used multivariate logistic regression to identify the significant determinants associated with lupus flares and performed regression for each organ flare outcome. They based regression inference on generalized estimating equations to account for the time repeated outcomes.

The study’s results showed statistically significant associations between environmental factors and lupus in multiple areas. Rash, serositis, hematologic and joint flares were associated with an increase in temperature. Renal flares decreased as the temperature and ozone concentration increased. . Joint, neurologic, haematologic and pulmonary flares were associated with residual wind. Humidity was significantly associated with joint and serositis flares. PM2.5 concentration was significantly associated with rash, joints, serositis and haematologic flares.

While the study’s findings show a strong association between changes in atmospheric and environmental variables 10 days prior to a patient clinic visit and organ-specific lupus activity at the visit, no environmental or atmospheric factor had a general association with all organ-specific lupus flares.

These findings raise concern for a potentially significant impact of atmospheric changes on the occurrence of organ-specific lupus flares, but further studies are necessary to confirm this effect and to potentially explain it. Atmospheric effects may have an important impact on lupus clinical trial design and outcomes,” says Dr Stojan. “From a global perspective, these findings could implicate climate change and global warming as important factors in the rapidly changing epidemiology of lupus worldwide. Ultimately, these findings are the first step to vindicating the great majority of lupus patients who are convinced that their disease is influenced by weather changes and who inspired this research.”

Study finds ultrasound to guide treatment strategy not beneficial in early RA

A treatment strategy guided by ultrasound information use does not appear to provide better treatment decisions in patients with early rheumatoid arthritis.

The study, presented at the 2019 ACR/ARP Meeting, did not find any additional reduction in MRI inflammation or structural damage when compared to a conventional treat-to-target strategy.

Researchers at Diakonhjemmet Hospital in Oslo, Norway wanted to determine whether treatment outcomes in early RA can be improved by targeting imaging remission, assessed by ultrasound in addition to clinical remission. Previous results from the ARCTIC and TaSER trials (Haavardsholm et al. BMJ 2016; Dale et al. ARD 2016), did not show that adding structured ultrasound assessment to a treat-to-target strategy was beneficial to early RA patients. However, results from both of those studies showed a trend toward less radiographic progression in the ultrasound arms.

Patients who have been seemingly successfully treated and are free of clinical signs and symptoms of disease may continue to develop permanent structural joint damage. There is a need to find better ways to identify these patients and prevent this development,” says Espen A. Haavardsholm, MD, PhD a rheumatologist at Diakonhjemmet Hospital and the study’s senior author. “The purpose of this follow-up study was to use MRI, which is reliable, objective and more sensitive than X-ray, to make a secondary assessment of inflammatory activity and structural damage progression in the two study arms. If there really were a difference, we would expect to see it in the MRI results.

The randomised trial used data from the ARCTIC trial, including 230 DMARD-naïve patients with early RA who were aged 18 to 75. Patients were randomised 1:1 to follow either an ultrasound-guided strategy targeting DAS (Disease Activity Score) of less than 1.6 with no swollen joints and no power-Doppler signal in any joint, or a conventional strategy targeting DAS of less than 1.6 and no swollen joints. Treatment for all patients began with methotrexate, then escalated to combination therapy with methotrexate/sulfasalazine/hydroxychloroquine, then a biologic DMARD.

In the ultrasound group, patients stepped up their treatment if the ultrasound score indicated a need, overruling the DAS or swollen joint count results. MRI was performed six times on patients’ dominant hand, then scored in chronological order by a blinded reader, according to the OMERACT RA MRI Scoring System. There were 218 patients, or 116 using ultrasound-guided strategy and 102 using a conventional strategy, who had MRI at the study’s baseline and one or more follow-up visits, and their MRI results were analysed.

The study’s results showed no statistically significant baseline differences between the two treatment groups in either of the combined MRI scores. The mean combined MRI inflammation score decreased during the first year in the ultrasound group by -64.2 and in the conventional strategy group by -59.4, and these scores were maintained at the same level throughout the second year of follow-up. There was no significant difference in change from baseline between the two groups at any time. The mean combined MRI damage score showed a small increase over time, without any significant difference between the two groups. In the ultrasound group, 39% of patients had MRI erosive progression compared to 33% in the conventional strategy group.

Our findings confirm the main conclusion from the ARCTIC trial that targeting ultrasound remission does not lead to improved results,” says Professor Haavardsholm. “The main message is that people with RA should be diagnosed and started on treatment early, monitored closely, and treatment should be stepped up aggressively until the target of clinical remission is reached. This strategy has proven very successful. However, going beyond this by aiming to also achieve imaging remission increases treatment cost and effort, but does not significantly further improve the results.

So, the ARCTIC trial does not support inclusion of ultrasound examination as a routine measure to guide treatment in early RA. Ultrasound might be a useful tool in other settings, such as when clinical findings are inconclusive. For patients, this means that if you feel that the medication has worked, your joints feel well and your rheumatologist cannot find any signs of active joint inflammation by physical examination, there is in most cases no need to go through additional imaging exams to determine that your disease is under satisfactory control with your current medication.”

Limited access to SLE lab tests in developing nations

Supportive laboratory assays to diagnose lupus, specifically the antinuclear antibody (ANA) test, are less often offered in developing nations due to a relative lack of resources, according to a presentation at the 2019 ACR/ARP Meeting.

This greatly reduced the diagnostic utility of ANA as an entry criterion for lupus classification in Ghanaian and Nigerian cohorts compared to African American cohorts in the United States. This emphasises an urgent need for broader clinical trials and ANA testing to participants in developing countries.

Diagnostic criteria for SLE are important to generate reliable epidemiologic data. Prevalence of SLE in West Africa is falsely low because of barriers to accurate diagnostic testing, including lack of resources and the labour-intensive nature of these tests. The newly developed 2019 ACR/EULAR SLE classification criteria tool may improve diagnostic sensitivity and specificity compared to the previously established ACR and SLICC criteria. This new study investigated the performance of each set of criteria in two West African lupus cohorts from Korle bu Teaching Hospital in Ghana and Lagos University Teaching Hospital in Nigeria and compared it to an African American cohort at New York University/Langone Medical Center in New York City.

African SLE patients throughout the diaspora are undertreated and understudied. This is in part due to the tendency for these individuals to hail from resource-limited areas of the world. In vetting diagnostic criteria, it is important to consider how more sophisticated testing may exacerbate existing disparities in diagnosis, treatment, and research,” says Ashira D Blazer, MD, MSCI, assistant professor of medicine, Division of Rheumatology, at New York University Langone Medical Center and the study’s lead author. “Lack of widely available testing for ANA, the entry criterion to classify SLE using the 2019 ACR/EULAR classification criteria, throughout sub-Saharan Africa could impact SLE clinical care and slow down research”, she adds. “We aimed to test the diagnostic efficiencies of each criteria in the USA compared to two low- or middle-income countries.”

The researchers collected data on 355 patients with SLE for the study, including 151 African American patients in the US, 110 patients in Ghana and 94 patients in Nigeria. All were diagnosed with lupus by expert clinicians. They gathered clinical information including demographics, SLE criteria, SLEDAI scores, SLICC damage indexes, vital signs and laboratory values that were available at the initial patient encounter. Longitudinal data was collected, at six-month intervals, over the course of at least one year during routine clinical visits. When necessary, the researchers also retrospectively reviewed clinical charts. They calculated the proportion of patients in each of the three cohorts who met each of the systems for classifying patients with lupus: (1) ACR, (2) SLICC and the (3) 2019 ACR/EULAR Classification Criteria for SLE.

The African American cohort’s demographics included an average age of 43 years, 90% were women, mean SLE disease duration of 14.3 years; and 96% met the ACR criteria, 96% met the SLICC criteria and 95% met the ACR/EULAR criteria. In the Ghanaian cohort, the average age was 32 years, all were women, the mean SLE disease duration was 2.2 years; and 85% met the ACR criteria, 84% met the SLICC criteria and 62% met the ACR/EULAR criteria. In the Nigerian cohort, the average age was 35, 97% were women, the mean SLE disease duration was 4.4 years, and 90% met the ACR criteria, 87% met the SLICC criteria and 61% met the ACR/EULAR criteria.

Researchers found discrepancies in the data due largely to missing laboratory data, particularly immunologic and haematologic studies. While none of the African-American cohort were missing ANA test results, 26% of the Ghanaian cohort and 33% of the Nigerian cohort were missing ANA results. Compared to both the Ghanaian and Nigerian cohorts, the African-American cohort was more likely to meet ACR, SLICC and ACR/EULAR criteria. While the ANA entry criterion greatly diminished the diagnostic utility of the ACR/EULAR classification criteria in both the Ghanaian and Nigerian cohorts, the criteria’s weighted point system performed better than either the ACR or SLICC criteria, with 96% of the African-American, 92% of the Ghanaian and 95% of the Nigerian cohorts earning a sufficient number of diagnostic points.

The new clinical indices provided better diagnostic efficiency in the developing world than either the ACR or SLICC criteria. These findings were enlightening, and they solidified an important concept: that SLE is a clinical diagnosis first,” says Dr. Blazer. “While research partnerships across the international economic divides might provide ANA testing, it is imperative that no new barriers be created for regional investigators who might struggle to disseminate data lacking the international community’s required laboratory results.”

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