An international audit of the management of dyslipidaemia and hypertension in patients with rheumatoid arthritis: results from 19 countries.

AIMS: To assess differences in estimated cardiovascular disease (CVD) risk among rheumatoid arthritis (RA) patients from different world regions and to evaluate the management and goal attainment of lipids and blood pressure (BP). METHODS AND RESULTS: The survey of CVD risk factors in patients with RA was conducted in 14 503 patients from 19 countries during 2014-19. The treatment goal for BP was <140/90 mmHg. CVD risk prediction and lipid goals were according to the 2016 European guidelines. Overall, 21% had a very high estimated risk of CVD, ranging from 5% in Mexico, 15% in Asia, 19% in Northern Europe, to 31% in Central and Eastern Europe and 30% in North America. Of the 52% with indication for lipid-lowering treatment (LLT), 44% were using LLT. The lipid goal attainment was 45% and 18% in the high and very high risk groups, respectively. Use of statins in monotherapy was 24%, while 1% used statins in combination with other LLT. Sixty-two per cent had hypertension and approximately half of these patients were at BP goal. The majority of the patients used antihypertensive treatment in monotherapy (24%), while 10% and 5% as a two- or three-drug combination. CONCLUSION: We revealed considerable geographical differences in estimated CVD risk and preventive treatment. Low goal attainment for LLT was observed, and only half the patients obtained BP goal. Despite a high focus on the increased CVD risk in RA patients over the last decade, there is still substantial potential for improvement in CVD preventive measures.

Vitamin D supplementation in systemic lupus erythematosus: relationship to disease activity, fatigue and the interferon signature gene expression.

BACKGROUND: In addition to the well-known role of vitamin D in calcium homeostasis and bone metabolism, vitamin D is important in the modulation of the immune system and inflammatory processes. Vitamin D deficiency is common in patients with systemic lupus erythematosus (SLE), possibly as a result of sun avoidance. The aim of this prospective open-label study was to assess the effect of the treatment of vitamin D deficiency and insufficiency in SLE patients, particularly with regards to disease activity, fatigue and interferon signature gene expression. METHODS: 31 SLE patients, 13 with vitamin D deficiency and 18 with vitamin D insufficiency were treated with vitamin D3. They were supplemented with vitamin D3 8000 IU daily for 8 weeks if they were vitamin D deficient, or 8000 IU daily for 4 weeks if they were insufficient. This was followed by 2000 IU daily maintenance. They were assessed at baseline, after 6 and 12 months by means of an interview, filling in questionnaires and blood tests. The expression of 12 interferon signature genes in RNA extracted from whole blood was measured by using QuantiGene Plex technology. RESULTS: An improvement in disease activity measured by systemic lupus erythematosus disease activity index-2K (SLEDAI-2K; p = 0.028) and fatigue measured by fatigue severity scale (FSS; p = 0.071) at 12 months were noted. A significant decrease in anti-double stranded deoxyribonucleic acid (dsDNA) titre (p = 0.045) was also noted. The mean interferon signature gene expression score decreased from baseline to 6 months, however statistical significance was not achieved (p = 0.165). CONCLUSIONS: Improved disease activity and fatigue have been noted when Vitamin D has been supplemented in vitamin D deficient/insufficient SLE patients. One possible mechanism could be the suppression of the interferon signature gene expression. TRIAL REGISTRATION: The study was registered with the ISRCTN registry on 12/04/2021 (Trial ID: ISRCTN59058825).

Diabetes mellitus and cardiovascular risk management in patients with rheumatoid arthritis: an international audit.

AIM: The objective was to examine the prevalence of atherosclerotic cardiovascular disease (ASCVD) and its risk factors among patients with RA with diabetes mellitus (RA-DM) and patients with RA without diabetes mellitus (RAwoDM), and to evaluate lipid and blood pressure (BP) goal attainment in RA-DM and RAwoDM in primary and secondary prevention. METHODS: The cohort was derived from the Survey of Cardiovascular Disease Risk Factors in Patients with Rheumatoid Arthritis from 53 centres/19 countries/3 continents during 2014-2019. We evaluated the prevalence of cardiovascular disease (CVD) among RA-DM and RAwoDM. The study population was divided into those with and without ASCVD, and within these groups we compared risk factors and CVD preventive treatment between RA-DM and RAwoDM. RESULTS: The study population comprised of 10 543 patients with RA, of whom 1381 (13%) had DM. ASCVD was present in 26.7% in RA-DM compared with 11.6% RAwoDM (p<0.001). The proportion of patients with a diagnosis of hypertension, hyperlipidaemia and use of lipid-lowering or antihypertensive agents was higher among RA-DM than RAwoDM (p<0.001 for all). The majority of patients with ASCVD did not reach the lipid goal of low-density lipoprotein cholesterol <1.8 mmol/L. The lipid goal attainment was statistically and clinically significantly higher in RA-DM compared with RAwoDM both for patients with and without ASCVD. The systolic BP target of <140 mm Hg was reached by the majority of patients, and there were no statistically nor clinically significant differences in attainment of BP targets between RA-DM and RAwoDM. CONCLUSION: CVD preventive medication use and prevalence of ASCVD were higher in RA-DM than in RAwoDM, and lipid goals were also more frequently obtained in RA-DM. Lessons may be learnt from CVD prevention programmes in DM to clinically benefit patients with RA .

Thermal characteristics of rheumatoid feet in remission: Baseline data.

OBJECTIVES: Studies have shown conflicting characteristic thermographic patterns of the feet in patients with active rheumatoid arthritis (RA). However, to date no studies have compared thermographic patterns of patients with RA in remission and healthy controls. Thus this study aimed to investigate whether the thermal characteristics of the feet of RA patients, in clinical and radiological remission differ to those of healthy controls. METHODS: Using convenience sampling, RA patients were recruited upon confirmed absence of synovitis by clinical examination and musculoskeletal ultrasound. Thermal images of the feet were taken. Each foot was subdivided into medial, central, lateral, forefoot and heel regions. Subsequently, temperatures in the different regions were analyzed and compared to a cohort of healthy adults. RESULTS: Data from 32 RA patients were compared to that of 51 healthy controls. The Independent samples T-Test demonstrated a significant difference in temperatures in all the regions of the forefoot between RA participants versus healthy subjects (Table 1). Using the One-Way ANOVA test, no significant difference was found between all the forefoot regions (p = 0.189) of RA patients. Independent sample T-test found significant differences in all heel regions between the two groups (Table 2). One-Way ANOVA demonstrated no significant differences (p = 0.983) between the different foot regions (n = 192) of RA patients. CONCLUSION: These findings suggest that RA patients in clinical and radiological remission exhibit significantly different feet thermographic patterns compared to healthy controls. This data will provide the basis for future studies to assess whether thermographic patterns change with disease activity.

The Epidemiology and Outcomes of Septic Arthritis in the Maltese Islands: A Hospital-Based Retrospective Cohort Study.

OBJECTIVE/AIM: Septic arthritis is an uncommon but important disease with significant morbidity and mortality, especially if inadequately managed. The aim of this epidemiological study was to identify the characteristics and outcomes of patients treated for septic arthritis at Mater Dei Hospital, Malta, over a 10-year period. METHODS: This was a retrospective observational study. Patients diagnosed with septic arthritis between 2008 and 2018 were recruited. Cases were identified by reviewing all inhospital episodes of patients diagnosed with septic arthritis according to Newman criteria. RESULTS: There were 124 cases of native joint septic arthritis and 138 of prosthetic joint infection. Cases were present amongst all age groups, with the highest incidence amongst those aged 61-70 years for both native and prosthetic infections. Fever was present in around 40% of cases. Raised white cell count was prevalent in 66.9% of native joint infections and 52.9% of prosthetic joints. Elevated C-reactive protein was overwhelmingly seen in most cases, present in 93.5% (median=159.5 mg/L; IQR=85.8-291) of native joints and 92.0% of prosthetic joint infections (median=68.7 mg/L; IQR=20.5-186). Over 55% of patients had one or more risk factors for joint sepsis, diabetes mellitus being the most prevalent clinical comorbidity (22.6% and 24.6% for native and prosthetic joint infections respectively). Synovial cultures were positive in 66% and 82% of native and prosthetic joint aspirates respectively. Staphylococcus aureus was the most commonly isolated organism from both native and prosthetic joint infection, followed by streptococcal infections in native joints and coagulase negative staphylococci and gram-negative infections in prosthetic joints. Fifteen deaths were directly attributed to joint sepsis. CONCLUSION: Absence of fever and elevated white cell count does not exclude the diagnosis. The mortality rate due to septic arthritis in this cohort of patients was found to be 5.7%. All deaths occurred in elderly patients with clinical comorbidities suggesting that this group is at highest risk.

A comparison of thermographic characteristics of the hands and wrists of rheumatoid arthritis patients and healthy controls.

Thermal imaging has been applied to detect possible temperature variations in various rheumatic disorders. This study sought to determine whether rheumatoid arthritis (RA) patients without active synovitis in their hands exhibit different baseline thermographic patterns of the fingers and palms when compared to healthy individuals. Data from 31 RA patients were compared to that of 51 healthy controls. The RA patients were recruited upon confirmed absence of synovitis by clinical examination and musculoskeletal ultrasound. Participants underwent medical infrared imaging of the regions of interest (ROIs). Significant differences were found between the mean temperatures of the palm regions (29.37 °C (SD2.2); n = 306) and fingers (27.16 °C (SD3.2); n = 510) of the healthy participants when compared to the palm regions (31.4(SD1.84)°C; n = 186) and fingers (30.22 °C (SD2.4); n = 299) of their RA counterparts (p = 0.001), with the latter group exhibiting higher temperatures in all ROIs. Logistic regression models confirm that both palm and finger temperature increase significantly in RA without active inflammation. These innovative findings provide evidence that baseline thermal data in RA differs significantly from healthy individuals. Thermal imaging may have the potential to become an adjunct assessment method of disease activity in patients with RA.

Patients' perspective of a dedicated biologic clinic for inflammatory arthritis.

PURPOSE: The purpose of this paper is to assess the patient's perspective on a dedicated clinic set up for patients diagnosed with an inflammatory arthritis who are being treated with a biologic. It proposes that dedicated clinics offer better overall care. The aim of this quality improvement survey is to evaluate the level of patient satisfaction with this clinic and identify any unmet needs. DESIGN/METHODOLOGY/APPROACH: This study was based on a quality improvement survey, which was developed using Zineldin's five qualities model and assessed various aspects pertaining to service quality and improvement. A structured interview approach was used and 44 consecutive patients were recruited. FINDINGS: This paper explores key aspects that influence patient satisfaction within a rheumatology outpatient setting such as education on arthritis and biologics and involvement in decision making. It provides insight on what patients value most and it also addresses organizational aspects that can have an impact on patient satisfaction. It suggests that service quality can be linked to the degree of patient satisfaction. RESEARCH LIMITATIONS/IMPLICATIONS: Direct interviewing of patients could have introduced a source of bias whilst questions are being answered. On the other hand, it provided an opportunity to clarify instantly any doubts and therefore avoiding any inadvertent errors. PRACTICAL IMPLICATIONS: This paper reinforces that specialized clinics enable the caring rheumatologist to provide better care for patients on biologics. Service providers should continue developing their services around the patient's needs and perspectives in order to continue improving the service. SOCIAL IMPLICATIONS: Dedicated biologic clinics allow more judicious monitoring of patients who are taking these highly efficacious but costly medications. ORIGINALITY/VALUE: This survey has reinforced that patients highly value dedicated clinics. These results strengthen the case that healthcare services should continue investing on specialized clinics.

Characterisation of Patients with Systemic Lupus Erythematosus in Malta: A Population Based Cohort Cross-Sectional Study.

Systemic Lupus Erythematosus (SLE) is a multisystemic autoimmune disorder. The aim of this study was to characterise the SLE patients living in Malta in order to estimate the prevalence and incidence of SLE and characterise the clinical presentation as well as identify any unmet needs. 107 SLE patients who fulfilled SLICC classification criteria were identified. These were invited to participate in the study by means of an interview, blood and urine tests, and filling of the following questionnaires: Fatigue Severity Scale (FSS), visual analogue scale (VAS) for fatigue, Hospital Anxiety and Depression Scale (HADS), VAS for pain, Pittsburgh Sleep Quality Index (PSQI), and modified Health Assessment Questionnaire (mHAQ). The estimated prevalence of SLE in Malta is 29.3 patients per 100,000 and the estimated incidence is 1.48 per 100,000 per year. 93.5% of SLE patients were female, and the mean age at diagnosis was 33.1 years. 60.8% were overweight or obese and body mass index (BMI) had a significant positive correlation with daily dose of prednisolone (R=0.177, p=0.046). 20.7% and 3.3% had a moderate and high disease activity, respectively, as measured by SLEDAI-2K. Disease activity had a significant positive correlation with functional disability measured by mHAQ (R=0.417, p<0.001). 56.5% had an abnormal level of fatigue (FSS >3.7) and 57.6% had a high level of anxiety (HADS ≥8). This study has identified a number of unmet needs of SLE patients, including obesity, uncontrolled disease activity, fatigue, and anxiety.

Dyspnoea in lupus.

A 32-year-old woman suffering from systemic lupus erythematosus presented with a 6-week history of progressive dyspnoea and pleuritic chest pain. Examination was normal apart from reduced air entry at the lung bases.Arterial blood gases showed hypoxaemia and chest X-ray revealed raised hemidiaphragms without any pleural effusions. Lung function showed a restrictive pathology while high-resolution chest CT and CT pulmonary angiogram were negative. Echocardiography showed normal ventricular diameters and no pericardial effusion. Reduced lung volumes and a positive fluoroscopic sniff test lead to a diagnosis of shrinking lung syndrome. Symptoms improved following treatment with glucocorticoids and non-invasive ventilation, but there was no change in lung function.A year later, our patient presented again with worsening dyspnoea. This time echocardiography revealed severe mitral stenosis with pulmonary hypertension. Mitral valve replacement was performed and dyspnoea resolved. Histology showed Libman-Sachs endocarditis.

Opinions of Maltese doctors and pharmacists on medication errors.

BACKGROUND: Pharmacovigilance directive 2010/84/EU focused attention on medication errors and encouraged regulators to identify causing and contributing factors. OBJECTIVES: (1) To study opinions of doctors/pharmacists on factors bearing a causal link to MEs as well as ways to minimise MEs (2) to test whether differences in opinion exist between subgroups of doctors and pharmacists working in community, hospital or office settings. METHODS: Different questionnaires were circulated to doctors and pharmacists. Respondents were subdivided according to their primary practice. RESULTS: 320 responses were received (204 doctors/116 pharmacists). Differences in opinion reaching statistical significance were observed on distractions from staff, overwork and fatigue, availability of technical resources and having more than 1 doctor on duty. For pharmacists', differences on issues of generic medicine availability and interruptions were found. CONCLUSION: Distractions and interruptions while executing tasks was flagged as an area requiring attention. Issues of overwork and fatigue affect especially doctors in hospital the majority of which are of the opinion that regulatory control on patient numbers could minimize errors. Increasing technical resources and keeping knowledge up-to-date, addressing overwork and high patient workloads have been identified as important areas when looking to reduce MEs.

Determining the presence of Peripheral Arterial Disease in patients with Rheumatoid Arthritis.

OBJECTIVES: The aim of the study was to determine the manifestations of PAD in a population of RA participants with no history of cardiovascular events. METHODS: A prospective observational non-experimental study was conducted on 100 participants presenting with RA and no history of significant cardiovascular events. Vascular assessment including Doppler spectral waveform analysis and Ankle Brachial Pressure Index was conducted. RESULTS: Triphasic waveforms was found in the Posterior Tibial Artery (PT) in 70% right foot, 66% left foot and Dorsalis Pedis Artery (DP) in both feet in the64% of the patients. Twenty-nine per cent of the participants had biphasic PT right foot and 33% had biphasic PT left foot. Thirty-six per cent had biphasic DP both feet whilst only one participant (1%) had a discontinuous monophasic PT of both feet. The ABPI readings were found to be normal in 96% of participants and mild PAD was found in only 4% of the study population. CONCLUSIONS: Results indicate that whilst the ABPI index was normal in the majority of participants, waveform analysis was suboptimal (biphasic) in approximately one-third of the study sample. These findings highlight that the assessment of peripheral arterial perfusion should utilize both modalities to identify patients with early PAD.

The effect of vitamin D on disease activity, fatigue and interferon signature gene expression in systemic lupus erythematosus.

Systemic Lupus Erythematosus (SLE) is multi-system autoimmune disorder, whose pathogenesis involves several cascades that lead to the production of interferon alpha, which then mediates the manifestations of the disease. In SLE, the overexpression of interferon regulated genes, produce a unique interferon signature. This has a positive correlation with disease activity. Vitamin D deficiency is highly prevalent in SLE; the role of vitamin D in the course and prognosis of SLE is unknown. Vitamin D deficiency has been associated with a higher disease activity in SLE. Fatigue is also highly prevalent in SLE; its aetiology is multi-factorial. There is limited evidence on the relationship between vitamin D, fatigue and interferon signature gene expression. Further studies on this will establish whether treatment of vitamin D deficiency in SLE, has any significant effect on the level of fatigue and disease activity, and whether this could be due to the suppression of interferon signature gene expression.

Can rheumatologists diagnose and manage Giant Cell Arteritis better than non-rheumatologists? The Maltese Experience.

OBJECTIVES: Giant Cell Arteritis (GCA) remains a challenge both in terms of diagnosis and management as patients may present to several different specialists. The objectives were to determine incidence of biopsy-proven GCA in Malta and to compare the management between rheumatologists and non-rheumatologists. METHODS: This was a retrospective observational population study of patients with suspected GCA who underwent a temporal artery biopsy (TAB) between 2012 and 2015. Data collected consisted of demographics, presenting symptoms, TAB histology reports, treatment and outcome. The British Society for Rheumatology (BSR) 2010 guidelines were used as standard of care. RESULTS: 136 patients underwent a TAB for suspected GCA of which 26 were positive. The incidence of biopsy-proven GCA in Malta was 3.82 per 100,000 patient years in the over 50 population. There were 63 patients who were treated as GCA. Only 43.3% of confirmed cases had rheumatology input. TABs requested by rheumatologists were twice more likely to be positive compared to requests by non-rheumatologists (30.5% vs. 14.1%).The majority of patients were started on a Prednisolone dose between 40-60mg. Rheumatologists maintained patients on high doses for at least 1 month in 54% of cases as opposed to 20% under non-rheumatologists. Monitoring was more regular for cases followed up by rheumatologists (40% vs. 21%). CONCLUSIONS: Malta has a low incidence of biopsy proven GCA. Although rheumatologists are more likely to adhere to the recommended guidelines, improvement is needed. Rheumatologists should take the lead to minimise variation and optimise management of GCA.

Translation and validation of the Fatigue Severity Scale, Pittsburgh Sleep Quality Index and Modified Health Assessment Questionnaire into the Maltese Language, in a cohort of Maltese Systemic Lupus Erythematosus patients.

PURPOSE: The assessment of fatigue, sleep quality and functional disability requires the use of validated instruments such as the Fatigue Severity Scale (FSS), the Pittsburgh Sleep Quality Index (PSQI) and the Modified Health Assessment Questionnaire (mHAQ) respectively. The aim of this study was to translate and validate these instruments into the Maltese Language. METHOD: Forward translation from the original English version into Maltese was carried out by two translators. The two versions were compiled to produce a preliminary initial Maltese translation. This was translated back into English by two other translators. This led to the development of the pre-final version of the Maltese translation, which was pilot-tested in 20 bilingual patients with systemic lupus erythematosus. RESULTS: Psychometric testing revealed good reliability of the Maltese translation of the three questionnaires. Cronbach's alpha of the Maltese versions of the FSS, PSQI and mHAQ were 0.877, 0.859 and 0.897 respectively, showing good internal consistency. Validity of the Maltese version of the FSS was shown, since it had a significant positive correlation with visual analogue scale for fatigue (r=0.809, p<0.001). CONCLUSION: The Maltese translations were thus finalised, and could be used for clinical assessment or research purposes.

Pulmonary, renal and neurological comorbidities in patients with ankylosing spondylitis; implications for clinical practice.

Ankylosing spondylitis (AS) is associated with several comorbidities which contribute significantly to morbidity and mortality and add to the complexity of management. In addition to the well known extra-articular manifestations and increased cardiovascular risk, several pulmonary, renal, and neurological complications which have been associated with AS deserve equal attention. Whereas a clear link has been established for some manifestations, the evidence for other associations is less clear. Interstitial lung disease, apical fibrosis, secondary infection, and ventilatory restriction from reduced chest wall movement are well known pulmonary complications; more recently an association with sleep apnoea has been suggested. Renal amyloidosis and IgA nephropathy remain a treatment challenge which may respond to anti-TNF therapy. Atlanto axial subluxation and vertebral fractures can result in serious neurological complications and are notoriously difficult to diagnose unless a high level of suspicion is maintained. Despite several reports linking AS with demyelination a true link remains to be proved. This review discusses the prevalence, pathophysiology, and management of pulmonary, renal, and neurological complications, and implications for clinical practice.