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- Bertsias, G. K., et al.
(författare)
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EULAR points to consider for conducting clinical trials in systemic lupus erythematosus: literature based evidence for the selection of endpoints
- 2009
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Ingår i: Annals of the Rheumatic Diseases. - : BMJ. - 1468-2060 .- 0003-4967. ; 68:4, s. 477-483
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Forskningsöversikt (refereegranskat)abstract
- Objective: To assess available evidence on the use of end-points ( outcome measures) in clinical trials in systemic lupus erythematosus (SLE), as a part of the development of evidence-based recommendations for points to consider in clinical trials in SLE. Methods: The European League Against Rheumatism (EULAR) Task Force on SLE comprised 19 specialists, a clinical epidemiologist and a research fellow. Key questions addressing the evidence for clinical trial end-points in SLE were compiled using the Delphi technique. A systematic search of the PubMed and Cochrane Library databases was performed using McMaster/Hedges clinical query strategies and an array of relevant terms. Evidence was categorised based on sample size and type of design, and the categories of available evidence were identified for each recommendation. The strength of recommendation was assessed based on the category of available evidence and agreement on the statements was measured across the 19 specialists. Results: Eight questions were generated regarding end-points for clinical trials. The evidence to support each proposition was evaluated. The literature review revealed that most outcome measures used in phase 2/3 trials in SLE have not been formally validated in clinical trials, although some indirect validation has been undertaken. Conclusion: This systematic literature review forms the evidence base considered in the development of the EULAR recommendations for end-points in clinical trials in SLE.
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- Chavatza, K, et al.
(författare)
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EULAR RECOMMENDATION-BASED QUALITY INDICATORS (QIS) FOR SYSTEMIC LUPUS ERYTHEMATOSUS (SLE): ELABORATION, FINAL SET, PERFORMANCE AND INITIAL VALIDATION
- 2021
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Ingår i: ANNALS OF THE RHEUMATIC DISEASES. - : BMJ. - 0003-4967 .- 1468-2060. ; 80, s. 635-636
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Targets of therapy and quality of care are receiving increased attention in systemic lupus erythematosus (SLE).Objectives:To develop Quality Indicators (QIs) for the care of SLE patients based on the EULAR recommendations, and assess their performance.Methods:Using the published EULAR recommendations for SLE, we developed 44 candidate QIs. These were independently rated for validity and feasibility by 12 experts, analysed by a modified RAND/UCLA model and further scrutinized based on the scorings and expert opinion. (Fig.1) Adherence to the final set of QIs was tested in a cohort of 220 SLE patients combined with an assessment on its impact on disease outcomes such as flares, hospitalizations and organ damage.Results:The panel rated 18 QIs as valid and feasible. These involve diagnosis; disease and damage assessment; monitoring for lupus nephritis and drug toxicity; therapy and targets of therapy; fertility and pregnancy; and adjunct therapy (preventive measures for osteoporosis, vaccination, cardiovascular disease). On average, SLE patients received 54% (95%CI 52–56%) of the indicated care with adherence ranging from 41% for QIs related to monitoring to 88% for treatment-related QIs. Regarding targets of therapy, sustained remission or low disease activity were achieved in 27%, while 94% of patients received low-dose glucocorticoids, and 92% the recommended hydroxychloroquine dose. Dependent upon individual QI tested, adherence for lupus nephritis-related QIs was 88% for receiving appropriate adjunct therapy (ACE inhibitors) to 100% for being treated with the indicated immunosuppressive treatment. In contrast, adherence to QIs related to preventive measures and other adjunct therapies was moderate to low. Notably, patients who were eligible for cardiovascular risk modification, vaccination, and osteoporosis management received lower quality of care (40.5%, 47.7% and 45.5% respectively) while 91.4% had sunscreen protection. In reference to laboratory work-up and monitoring, complete laboratory work-up at diagnosis was performed in 48%, while disease activity and damage, were fully assessed only in 14.1% (in three consecutive visits) and 28.6% (annually) respectively, Similarly, reproductive health and pregnancy counselling adherence rates were modest estimated at 50% and 62% respectively. Higher adherence to the indicated care during follow-up (monitoring QIs) was associated with reduced risk for adverse outcomes during the last year of observation (OR 0.97, 95%CI 0.96-0.99). Patients who achieved sustained remission or LLDAS, exhibited fewer flares (OR=0.15, p-value<0.001) and damage accrual (OR=0.35, p-value<0.001). Of interest, patients who received low-dose of GCs or were appropriately vaccinated, had a lower risk of experiencing a flare (OR=0.23 and 0.46 respectively).Conclusion:A set of 18 QIs based on the EULAR recommendations for SLE was developed to be used towards improving care in SLE. Initial real-life data suggest variable degree of adherence with higher adherence resulting in reduced adverse outcomes.References:[1]Fanouriakis, et al., 2019 Update of the EULAR recommendations for the management of systemic lupus erythematosus. In Annals of the Rheumatic Diseases (Vol. 78, Issue 6, pp. 736–745). BMJ Publishing Group. https://doi.org/10.1136/annrheumdis-2019-215089.[2]Nikolopoulos, D., et al., Evolving phenotype of systemic lupus erythematosus in Caucasians: low incidence of lupus nephritis, high burden of neuropsychiatric disease and increased rates of late-onset lupus in the ‘Attikon’ cohort. Lupus, 29(5), 514–522. https://doi.org/10.1177/0961203320908932.Acknowledgements:This project has received funding from the European Research Council (ERC) under the European Union’s Horizon 2020 research and innovation programme (grant agreement No 742390)Disclosure of Interests:None declared
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- Chavatza, K, et al.
(författare)
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Quality indicators for systemic lupus erythematosus based on the 2019 EULAR recommendations: development and initial validation in a cohort of 220 patients
- 2021
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Ingår i: Annals of the rheumatic diseases. - : BMJ. - 1468-2060 .- 0003-4967. ; 80:9, s. 1175-1182
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Tidskriftsartikel (refereegranskat)abstract
- Quality of care is receiving increased attention in systemic lupus erythematosus (SLE). We developed quality indicators (QIs) for SLE based on the 2019 update of European League Against Rheumatism recommendations.MethodsA total of 44 candidate QIs corresponding to diagnosis, monitoring and treatment, were independently rated for validity and feasibility by 12 experts and analysed by a modified Research and Development Corporation/University of California Los Angeles model. Adherence to the final set of QIs and correlation with disease outcomes (flares, hospitalisations and organ damage) was tested in a cohort of 220 SLE patients with a median monitoring of 2 years (IQR 2–4).ResultsThe panel selected a total of 18 QIs as valid and feasible. On average, SLE patients received 54% (95% CI 52.3% to 56.2%) of recommended care, with adherence ranging from 44.7% (95% CI 40.8% to 48.6%) for diagnosis-related QIs to 84.3% (95% CI 80.6% to 87.5%) for treatment-related QIs. Sustained remission or low disease activity were achieved in 26.8% (95% CI 21.1% to 33.2%). Tapering of prednisone dose to less than 7.5 mg/day was achieved in 93.6% (95% CI 88.2% to 97.0%) while 73.5% (95% CI 66.6% to 79.6%) received the recommended hydroxychloroquine dose. Higher adherence to monitoring-related QIs was associated with reduced risk for a composite adverse outcome (flare, hospitalisation or damage accrual) during the last year of observation (OR 0.97 per 1% adherence rate, 95% CI 0.96 to 0.99).ConclusionWe developed QIs for assessing and improving the care of SLE patients. Initial real-life data suggest face validity, but a variable degree of adherence and a need for further improvement.
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| 7. |
- Fanouriakis, A, et al.
(författare)
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2019 update of the EULAR recommendations for the management of systemic lupus erythematosus
- 2019
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Ingår i: Annals of the rheumatic diseases. - : BMJ. - 1468-2060 .- 0003-4967. ; 78:6, s. 736-745
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Tidskriftsartikel (refereegranskat)abstract
- Our objective was to update the EULAR recommendations for the management of systemic lupus erythematosus (SLE), based on emerging new evidence. We performed a systematic literature review (01/2007–12/2017), followed by modified Delphi method, to form questions, elicit expert opinions and reach consensus. Treatment in SLE aims at remission or low disease activity and prevention of flares. Hydroxychloroquine is recommended in all patients with lupus, at a dose not exceeding 5 mg/kg real body weight. During chronic maintenance treatment, glucocorticoids (GC) should be minimised to less than 7.5 mg/day (prednisone equivalent) and, when possible, withdrawn. Appropriate initiation of immunomodulatory agents (methotrexate, azathioprine, mycophenolate) can expedite the tapering/discontinuation of GC. In persistently active or flaring extrarenal disease, add-on belimumab should be considered; rituximab (RTX) may be considered in organ-threatening, refractory disease. Updated specific recommendations are also provided for cutaneous, neuropsychiatric, haematological and renal disease. Patients with SLE should be assessed for their antiphospholipid antibody status, infectious and cardiovascular diseases risk profile and preventative strategies be tailored accordingly. The updated recommendations provide physicians and patients with updated consensus guidance on the management of SLE, combining evidence-base and expert-opinion.
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| 9. |
- Fanouriakis, A, et al.
(författare)
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2019 Update of the Joint European League Against Rheumatism and European Renal Association-European Dialysis and Transplant Association (EULAR/ERA-EDTA) recommendations for the management of lupus nephritis
- 2020
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Ingår i: Annals of the rheumatic diseases. - : BMJ. - 1468-2060 .- 0003-4967. ; 79:6, s. 713-723
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Tidskriftsartikel (refereegranskat)abstract
- To update the 2012 EULAR/ERA–EDTA recommendations for the management of lupus nephritis (LN).MethodsFollowing the EULAR standardised operating procedures, a systematic literature review was performed. Members of a multidisciplinary Task Force voted independently on their level of agreeement with the formed statements.ResultsThe changes include recommendations for treatment targets, use of glucocorticoids and calcineurin inhibitors (CNIs) and management of end-stage kidney disease (ESKD). The target of therapy is complete response (proteinuria <0.5–0.7 g/24 hours with (near-)normal glomerular filtration rate) by 12 months, but this can be extended in patients with baseline nephrotic-range proteinuria. Hydroxychloroquine is recommended with regular ophthalmological monitoring. In active proliferative LN, initial (induction) treatment with mycophenolate mofetil (MMF 2–3 g/day or mycophenolic acid (MPA) at equivalent dose) or low-dose intravenous cyclophosphamide (CY; 500 mg × 6 biweekly doses), both combined with glucocorticoids (pulses of intravenous methylprednisolone, then oral prednisone 0.3–0.5 mg/kg/day) is recommended. MMF/CNI (especially tacrolimus) combination and high-dose CY are alternatives, for patients with nephrotic-range proteinuria and adverse prognostic factors. Subsequent long-term maintenance treatment with MMF or azathioprine should follow, with no or low-dose (<7.5 mg/day) glucocorticoids. The choice of agent depends on the initial regimen and plans for pregnancy. In non-responding disease, switch of induction regimens or rituximab are recommended. In pure membranous LN with nephrotic-range proteinuria or proteinuria >1 g/24 hours despite renin–angiotensin–aldosterone blockade, MMF in combination with glucocorticoids is preferred. Assessment for kidney and extra-renal disease activity, and management of comorbidities is lifelong with repeat kidney biopsy in cases of incomplete response or nephritic flares. In ESKD, transplantation is the preferred kidney replacement option with immunosuppression guided by transplant protocols and/or extra-renal manifestations. Treatment of LN in children follows the same principles as adult disease.ConclusionsWe have updated the EULAR recommendations for the management of LN to facilitate homogenization of patient care.
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