Objective
Rheumatoid arthritis is associated with increased cardiovascular risk. In ankylosing spondylitis (AS), there is a paucity of information concerning this risk. Our objective was to assess ...the incidence of myocardial infarction (MI) or strokes and the cardiovascular risk profile in AS patients.
Methods
We performed a systematic literature review using PubMed, EMBase, and the Cochrane Library up to August 2009. Incidence of MI or stroke was calculated by metaproportion. For cardiovascular risk factors, differences between AS patients and controls were expressed by standardized mean differences using inverse of variance method.
Results
For MI, 8 longitudinal studies were included. In controls (n = 82,745), 1,318 MI cases were observed (4.6%; 95% confidence interval 95% CI 1.2%, 10.0%). In AS patients (n = 3,279), 224 MI cases were reported (incidence 7.4%; 95% CI 5.2%, 10.0%). The increase in MI cases in AS patients was not significant (risk ratio 1.88; 95% CI 0.83, 4.28). For stroke, 7 longitudinal studies reported 327 strokes in AS patients (n = 31,949), which is an incidence of 2.2% (95% CI 1.3%, 3.4%). In controls (n = 7,372), one study reported 170 strokes (2.3%; 95% CI 2.0%, 2.7%). For cardiovascular risk factors, 15 case–control studies and 9 s were included (n = 1,214 for patients and n = 1,000 for controls). AS patients were characterized by a higher weighted mean intima‐media thickness and higher risk of metabolic syndrome. In AS patients, there was a significant decrease in triglycerides, total cholesterol, and high‐density lipoprotein (HDL) cholesterol.
Conclusion
AS patients appear to be at higher risk of MI, which could be due to low HDL cholesterol levels or to systemic inflammation. Management of cardiovascular risk factors and control of systemic inflammation should be taken into account in AS.
Abstract Background Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core ...set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process. Methods Literature searches and iterative consensus process (surveys and group meetings) of stakeholders including patients, health professionals, and methodologists within and outside rheumatology. Results To comprehensively sample patient-centered and intervention-specific outcomes, a framework emerged that comprises three core “Areas,” namely Death, Life Impact, and Pathophysiological Manifestations; and one strongly recommended Resource Use. Through literature review and consensus process, core set development for any specific health condition starts by identifying at least one core “Domain” within each of the Areas to formulate the “Core Domain Set.” Next, at least one applicable measurement instrument for each core Domain is identified to formulate a “Core Outcome Measurement Set.” Each instrument must prove to be truthful (valid), discriminative, and feasible. In 2012, 96% of the voting participants ( n = 125) at the OMERACT 11 consensus conference endorsed this model and process. Conclusion The OMERACT Filter 2.0 explicitly describes a comprehensive conceptual framework and a recommended process to develop core outcome measurement sets for rheumatology likely to be useful as a template in other areas of health care.
To update the evidence for the safety of synthetic disease-modifying antirheumatic drugs (sDMARDs), glucocorticoids (GC) and biological DMARDs (bDMARDs) in patients with rheumatoid arthritis (RA) to ...inform the European League Against Rheumatism (EULAR) recommendations for the management of RA.
Systematic literature review (SLR) of observational studies (including registries). Interventions were any bDMARD (anakinra, infliximab, etanercept, adalimumab, rituximab, abatacept, tocilizumab, golimumab or certolizumab pegol) or sDMARD (methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, gold/auranofin, azathioprine, chlorambucil, chloroquine, cyclosporin, cyclophosphamide, mycophenolate, minocycline, penicillamine, tacrolimus or tofacitinib) and a comparator was required. Information on GCs was collected from the included studies. All safety outcomes were included.
Forty-nine observational studies addressing diverse safety outcomes of therapy with bDMARDs met eligibility criteria. Substantial heterogeneity precluded meta-analysis of any of the outcomes. Patients on tumour necrosis factor inhibitors (TNFi) compared to patients on conventional sDMARDs had a higher risk of serious infections (adjusted HR (aHR) 1.1-1.8), a higher risk of tuberculosis, and an increased risk of infection by herpes zoster cannot be excluded. Patients on TNFi did not have an increased risk for malignancies in general, lymphoma or non-melanoma skin cancer, but the risk of melanoma may be slightly increased (aHR 1.5). From the studies identified on conventional sDMARDs, no new safety signals were found.
The findings from this SLR confirm the known safety pattern of sDMARDs and bDMARDs for the treatment of RA.
To update the evidence for the efficacy of biological disease-modifying antirheumatic drugs (bDMARD) in patients with rheumatoid arthritis (RA) to inform the European League Against Rheumatism(EULAR) ...Task Force treatment recommendations.
Medline, Embase and Cochrane databases were searched for articles published between January 2009 and February 2013 on infliximab, etanercept, adalimumab, certolizumab-pegol, golimumab, anakinra, abatacept, rituximab, tocilizumab and biosimilar DMARDs (bsDMARDs) in phase 3 development. Abstracts from 2011 to 2012 American College of Rheumatology (ACR) and 2011-2013 EULAR conferences were obtained.
Fifty-one full papers, and 57 abstracts were identified. The randomised controlled trials (RCT) confirmed the efficacy of bDMARD+conventional synthetic DMARDs (csDMARDs) versus csDMARDs alone (level 1B evidence). There was some additional evidence for the use of bDMARD monotherapy, however bDMARD and MTX combination therapy for all bDMARD classes was more efficacious (1B). Clinical and radiographic responses were high with treat-to-target strategies. Earlier improvement in signs and symptoms were seen with more intensive initial treatment strategies, but outcomes were similar upon addition of bDMARDs in patients with insufficient response to MTX. In general, radiographic progression was lower with bDMARD use, mainly due to initial treatment effects. Although patients may achieve bDMARD- and drug-free remission, maintenance of clinical responses was higher with bDMARD continuation (1B), but bDMARD dose reduction could be applied (1B). There was still no RCT data for bDMARD switching.
The systematic literature review confirms efficacy of biological DMARDs in RA. It addresses different treatment strategies with the potential for reduction in therapy, particularly with early disease control, and highlights emerging therapies.
The emergence of COVID-19 in early 2020 led to unprecedented changes to rheumatology clinical practice worldwide, including the closure of research laboratories, the restructuring of hospitals and ...the rapid transition to virtual care. As governments sought to slow and contain the spread of the disease, rheumatologists were presented with the difficult task of managing risks, to their patients as well as to themselves, while learning and implementing new systems for remote health care. Consequently, the COVID-19 pandemic led to a transformation in health infrastructures and telemedicine that could become powerful tools for rheumatologists, despite having some limitations. In this Viewpoint, five experts from different regions discuss their experiences of the pandemic, including the most challenging aspects of this unexpected transition, the advantages and limitations of virtual visits, and potential opportunities going forward.
Among available digital apps, those providing personalized video exercises may be helpful for individuals undergoing functional rehabilitation.
We aimed to assess the effectiveness of apps providing ...personalized video exercises to support rehabilitation for people with short- and long-term disabling conditions, on functional capacity, confidence in exercise performance, health care consumption, health-related quality of life, adherence, and adverse events.
In this systematic review, we searched MEDLINE, CENTRAL, and Embase databases up to March 2022. All randomized controlled trials evaluating the effect of apps providing personalized video exercises to support rehabilitation for any condition requiring physical rehabilitation were included. Selection, extraction, and risk of bias assessment were performed by 2 independent reviewers. The primary outcome was functional capacity at the end of the intervention. The secondary outcomes included confidence in exercise performance, care consumption, health-related quality of life, adherence, and adverse events. A meta-analysis was performed where possible; the magnitude of the effect was assessed with the standardized mean difference (SMD).
From 1641 identified references, 10 papers (n=1050 participants, 93% adults) were included: 7 papers (n=906 participants) concerned musculoskeletal disorders and 3 (n=144 participants) concerned neurological disorders. Two (n=332 participants) were employee based. The apps were mostly commercial (7/10); the videos were mostly elaborated on by a physiotherapist (8/10). The duration of app use was 3-48 weeks. All included studies had a high overall risk of bias. Low-quality evidence suggested that the use of apps providing personalized video exercises led to a significant small to moderate improvement in physical function (SMD 0.35, 95% CI 0.19-0.51; Phet=.86; I
=0%) and confidence in exercise performance (SMD 0.67; 95% CI 0.37-0.96; Phet=.22; I
=33%). Because of the very low quality of the evidence, the effects on quality of life and exercise adherence were uncertain. Apps did not influence the rate of adverse events.
Apps providing personalized video exercises to support exercise performance significantly improved physical function and confidence in exercise performance. However, the level of evidence was low; more robust studies are needed to confirm these results.
PROSPERO CRD42022323670; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=323670.
In healthcare, physical activity can be monitored in two ways: self-monitoring by the patient himself or external monitoring by health professionals. Regarding self-monitoring, wearable activity ...trackers allow automated passive data collection that educate and motivate patients. Wearing an activity tracker can improve walking time by around 1500 steps per day. However, there are concerns about measurement accuracy (e.g., lack of a common validation protocol or measurement discrepancies between different devices). For external monitoring, many innovative electronic tools are currently used in rheumatology to help support physician time management, to reduce the burden on clinic time, and to prioritize patients who may need further attention. In inflammatory arthritis, such as rheumatoid arthritis, regular monitoring of patients to detect disease flares improves outcomes. In a pilot study applying machine learning to activity tracker steps, we showed that physical activity was strongly linked to disease flares and that patterns of physical activity could be used to predict flares with great accuracy, with a sensitivity and specificity above 95%. Thus, automatic monitoring of steps may lead to improved disease control through potential early identification of disease flares. However, activity trackers have some limitations when applied to rheumatic patients, such as tracker adherence, lack of clarity on long-term effectiveness, or the potential multiplicity of trackers.
Capacity to work is impacted by psoriatic arthritis (PsA). Our objective was to describe the course of work productivity and leisure activity in patients with PsA treated with biologic (b) and ...targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs).
A systematic literature review identified all trials and observational studies published January 1, 2010-October 22, 2021, reporting work productivity using the Work Productivity and Activity Impairment Questionnaire (WPAI) in patients with PsA treated with b/tsDMARDs. Outcomes for WPAI domains (absenteeism, presenteeism, total work productivity, and activity impairment) were collected at baseline and time point closest to 24 weeks of treatment. A random effects meta-analysis of single means was conducted to calculate an overall absolute mean change from baseline for each WPAI domain.
Twelve studies (ten randomized controlled and two observational) assessing patients treated with adalimumab, bimekizumab, guselkumab, ixekizumab, risankizumab, secukinumab, or upadacitinib were analysed. Among 3741 employed patients, overall mean baseline scores were 11.4%, 38.7%, 42.7%, and 48.9% for absenteeism, presenteeism, total work productivity impairment, and activity impairment, respectively. Estimated absolute mean improvements (95% confidence interval) to week 24 were 2.4 percentage points (%p) (0.6, 4.1), 17.8%p (16.2,19.3), 17.6%p (15.9,19.4), and 19.3%p (17.6, 21.0) respectively, leading to a mean relative improvement of 41% for total work productivity. The change in work outcomes in the b/tsDMARDs appeared similar.
This systematic literature review and meta-analysis confirmed that patients with active PsA have a substantially reduced capacity to work and participate in leisure activities. Substantial improvements across various WPAI domains were noted after 24 weeks of b/tsDMARD treatment, especially in presenteeism, total work productivity, and activity impairment. These findings may be useful for reimbursement purposes and in the context of shared decision-making. This systematic literature review (SLR) of randomized clinical trials and observational studies of biologic (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs b/tsDMARDs in patients with PsA found that at treatment introduction, patients presented with a 42.7% mean productivity loss per week as assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire. Through a meta-analysis comparing before/after values without adjustment for placebo response, we found that after 24 weeks of treatment with b/tsDMARDs, there was a mean absolute improvement of 17.6 percentage points and a mean relative improvement of 41% in total work productivity, with similar magnitudes of improvement in time spent at work and regular activities outside of work. These results provide clinical-, regulatory- and reimbursement decision-makers with data on the potential societal and socio-economic benefits of b/tsDMARDs in PsA.
Context:
Adipokines (leptin, adiponectin, resistin, visfatin) and ghrelin may be implicated in bone metabolism.
Objective:
The aim was to perform an overview of the influence of blood levels of ...adipokines or ghrelin on bone mineral density (BMD), osteoporotic status, and fracture risk in healthy men and women.
Data Sources:
We reviewed Medline, Embase, and Cochrane databases up to March 2010 and abstracts of international meetings from 2008 to 2009.
Study Selection:
Fifty-nine studies meeting the inclusion criteria (healthy men or women evaluated for both BMD or fracture risk and at least one adipokine and/or ghrelin levels) were analyzed in the systematic review of the 931 references found in the electronic databases.
Data Extraction:
We used a predefined extraction sheet.
Data Synthesis:
We performed meta-analyses using the method of the inverse of the variance estimated pooled correlations between adipokines/ghrelin and BMD. Inverse correlations between adiponectin levels and BMD were highlighted (pooled r from −0.14 to −0.4). Leptin is positively associated to BMD, especially in postmenopausal women (pooled r from 0.18 to 0.33). High levels of leptin were reported to be predictive of low risk of fractures, whereas high levels of adiponectin may be predictive of high risk of vertebral fractures in men only. No discriminative capacity of osteoporotic status was reported. We found no convincing data to support an association between resistin, visfatin, or ghrelin and BMD.
Conclusion:
Adiponectin is the most relevant adipokine negatively associated with BMD, independent of gender and menopausal status. Inconsistent associations between adipokines and BMD are probably confounded by body composition, in particular fat mass parameters.
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