ASAS recommendations for variables to be collected in clinical trials/epidemiological studies of spondyloarthritis: Figure 1

Dougados, Maxime; Braun, Jürgen; Vargas, Rubén Burgos; Gossec, Laure; Maksymowych, Walter P.; Sieper, Joachim; Heijde, Desirée van der

doi:10.1136/annrheumdis-2011-201038

Cited by 15 publications

(20 citation statements)

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“…Study data were collected in compliance with ASAS recommendations for clinical trials of SpA [ 34 ]. Imaging was read locally by the radiologist or rheumatologist providing care for the patient.…”

Section: Methodsmentioning

confidence: 99%

Evaluation of the nonsteroidal anti-inflammatory drug-sparing effect of etanercept in axial spondyloarthritis: results of the multicenter, randomized, double-blind, placebo-controlled SPARSE study

et al. 2014

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IntroductionIn clinical practice, nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly discontinued after response to biologic therapy is achieved in patients with axial spondyloarthritis (axSpA), but the impact of NSAID discontinuation has not been assessed in prospective controlled trials. The aim of the SPARSE study was to evaluate the effects of the anti-tumor necrosis factor agent etanercept on NSAID intake and conventional clinical outcomes in axSpA patients.MethodsIn the double-blind, placebo-controlled period, patients with active (mini Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4) axSpA despite optimal NSAID intake were randomized to receive etanercept 50 mg or placebo once weekly for 8 weeks. All patients were advised to taper/discontinue their NSAID intake during the treatment period. NSAID intake was self-reported by diary and Assessment of SpondyloArthritis International Society (ASAS)-NSAID scores calculated based on ASAS recommendations. The primary endpoint was change from baseline to week 8 in ASAS-NSAID score (analysis of covariance).ResultsIn 90 randomized patients at baseline, mean age (standard deviation) was 38.9 (11.8) years; disease duration, 5.7 (8.1) years; 59/90 (66%) were human leukocyte antigen-B27 positive; 51/90 (57%) had radiographic sacroiliitis; and 45/90 (50%) were magnetic resonance imaging sacroiliitis-positive. Mean ASAS-NSAID scores were similar between etanercept and placebo groups at baseline (98.2 (39.0) versus 93.0 (23.4)), as were BASDAI (6.0 (1.7) versus 5.9 (1.5)), and Bath Ankylosing Spondylitis Functional Index (5.2 (2.1) versus 5.1 (2.2)). Mean changes (SE) in ASAS-NSAID score from baseline to week 8 were –63.9 (6.1) and –36.6 (5.9) in the etanercept and placebo groups (between-group difference, –27.3; P = 0.002). Significantly higher proportions of patients receiving etanercept versus placebo had an ASAS-NSAID score <10 (46% versus 17%; P = 0.008) and ASAS-NSAID score of 0 (41% versus 14%; P = 0.013) at this time point. Significantly more patients in the etanercept versus placebo group achieved BASDAI50 (39% versus 18%; P = 0.032) and ASAS40 (44% versus 21%; P = 0.028) at week 8.ConclusionsIn patients with axSpA, etanercept was associated with clinically relevant NSAID-sparing effects in addition to significant improvements in conventional clinical outcomes.Trial registrationClinicalTrials.gov NCT01298531. Registered 16 February 2011.Electronic supplementary materialThe online version of this article (doi:10.1186/s13075-014-0481-5) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

Evaluation of the nonsteroidal anti-inflammatory drug-sparing effect of etanercept in axial spondyloarthritis: results of the multicenter, randomized, double-blind, placebo-controlled SPARSE study

et al. 2014

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“…In addition, extraspinal manifestations were assessed, including uveitis, psoriasis, inflammatory bowel disease, and swollen and tender joint counts (of 44 joints assessed), in accordance with the ASAS recommendations for studies of SpA (18). Quality of life was measured using the 18-item Ankylosing Spondylitis Quality of Life (ASQoL) scale (17), providing a score from 0 (good quality of life) to 18 (poor quality of life).…”

Section: Methodsmentioning

confidence: 99%

Co‐Occurrence and Characteristics of Patients With Axial Spondyloarthritis Who Meet Criteria for Fibromyalgia

Macfarlane

Barnish

Pathan

et al. 2017

Arthritis & Rheumatology

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Objective To estimate the proportion of patients with axial spondyloarthritis (SpA) in a UK national biologics registry who met criteria for fibromyalgia (FM), and to delineate the characteristics of these patients. Methods Two cohorts of patients are prospectively recruited from across 83 centers in the UK for the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis (BSRBR‐AS). All patients are required to meet Assessment of SpondyloArthritis international Society (ASAS) criteria for axial SpA. Patients are either newly starting biologic therapy (biologics cohort) or are naive to treatment with biologic agents (non‐biologics cohort) at the time of recruitment, and all patients are followed up prospectively. At recruitment and follow‐up, clinical information and measurements are recorded while patients complete the 2011 research criteria for FM and assessments of the level of disease activity and work impact. Results Of the patients registered in the BSRBR‐AS, 1,504 (68% male) were eligible for the current analysis, of whom 311 (20.7%) met the 2011 research criteria for FM. Prevalence of FM was similar between patients who fulfilled the modified New York criteria for AS (19.7%) and those who fulfilled ASAS imaging criteria but not the modified New York criteria (25.2%); however, among those who fulfilled only the ASAS clinical criteria, the prevalence of FM was lower (9.5%). Patients who met FM criteria reported significantly worse disease activity, function, global severity scores, and quality of life, and were more likely to have moderate or severe levels of mood disorder and clinically important fatigue. Patients who met FM criteria reported experiencing work impairment around half their working time. Meeting FM criteria was not related to elevated C‐reactive protein levels or most extraspinal manifestations, but was associated with a higher likelihood of having received biologic therapy. Conclusion Developing management approaches that would address the significant unmet clinical needs of the 1 in 5 patients with axial SpA who meet criteria for FM should be a research priority.

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“…Uveitis is one of the variables recommended by ASAS to be collected in epidemiological studies or clinical trials dealing with SpA. For such purpose, and current clinical practice, uveitis is defined as a diagnosis arrived at by an ophthalmologist or an episode suggestive of uveitis in a patient with a previous history of an episode diagnosed as uveitis by an ophthalmologist [43].…”

Section: Impact Of Uveitis Among Patients With Spamentioning

confidence: 99%

Acute Anterior Uveitis and Spondyloarthritis: More Than Meets the Eye

2015

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Ankylosing spondylitis (AS) and related forms of spondyloarthritis (SpA) are associated with some extra-articular features, and the most common symptomatic association is with acute anterior uveitis (AAU). Thus, approximately 40 % of patients with AS will experience a sudden onset of a unilateral anterior uveitis sometime during the course of their disease. Patients with AAU, especially those who are HLA-B27 positive, should be questioned about inflammatory low back pain and also evaluated for other clinical features of SpA. Since a prolonged delay in diagnosis is common among SpA patients and occurrence of AAU may be the reason for their first interaction with medical care, occurrence of AAU presents a unique opportunity for identifying such undiagnosed SpA patients. Therefore, a novel evidence-based algorithm called Dublin Uveitis Evaluation Tool (DUET) has been proposed to guide ophthalmologists and primary care physicians to refer appropriate AAU patients to rheumatologists. In a large two-phase study, approximately 40 % of patients presenting with idiopathic AAU were noted to have undiagnosed SpA, and DUET algorithm was noted to have excellent sensitivity (96 %) and specificity (97 %). It has a positive likelihood ratio (LR) 41.5 and negative LR 0.03. In most instances, the eye inflammation responds well to corticosteroid and mydriatic eye drops and without the need for additional therapy. Use of oral corticosteroids is reserved for patients, especially with associated chronic inflammatory bowel disease or psoriatic arthritis presenting with bilateral, chronic, anterior, and/or intermediate uveitis, and this treatment is rarely needed for more than a couple of weeks. A very small percentage may be more refractory to such treatment and require potential novel therapies, including the use of tumor necrosis factor blockers.

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ASAS recommendations for variables to be collected in clinical trials/epidemiological studies of spondyloarthritis: Figure 1

Cited by 15 publications

References 9 publications

Evaluation of the nonsteroidal anti-inflammatory drug-sparing effect of etanercept in axial spondyloarthritis: results of the multicenter, randomized, double-blind, placebo-controlled SPARSE study

Evaluation of the nonsteroidal anti-inflammatory drug-sparing effect of etanercept in axial spondyloarthritis: results of the multicenter, randomized, double-blind, placebo-controlled SPARSE study

Co‐Occurrence and Characteristics of Patients With Axial Spondyloarthritis Who Meet Criteria for Fibromyalgia

Acute Anterior Uveitis and Spondyloarthritis: More Than Meets the Eye

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