Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations

Aletaha, Daniel; Landewé, Robert; Karonitsch, Thomas; Bathon, Joan M.; Boers, Maarten; Bombardier, Claire; Bombardieri, Stefano; Choi, Hyon K.; Combe, Bernard; Dougados, Maxime; Emery, Paul; Gómez-Reino, Juan J.; Keystone, Edward; Koch, Gary G.; Kvien, Tore K; Martı́n-Mola, Emilio; Matucci‐Cerinic, M.; Michaud, Kaleb; O'Dell, James Robert; Paulus, Harold E.; Pincus, Theodore; Richards, P. Scott; Simon, Lee S.; Siegel, Jeffrey; Smolen, Josef S.; Sokka, Tuulikki; Strand, Vibeke; Tugwell, Peter; Heijde, Desirée van der; Riel, Piet van; Vlad, Steven C.; Vollenhoven, Ronald van; Ward, Michael M.; Weinblatt, Michael E.; Wells, George A.; White, Barbara; Wolfe, Frederick; Zhang, B; Zink, Angela; Felson, David T.

doi:10.1136/ard.2008.091454

Cited by 238 publications

(222 citation statements)

References 14 publications

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“…An alternate method may be via a discussion process among experts in the area, e.g. outcome measures for chronic pain studies [25], disease activity in rheumatoid arthritis [1]. Development of a definition for recovery from LBP may be amenable to either of these processes.…”

Section: Resultsmentioning

confidence: 99%

How is recovery from low back pain measured? A systematic review of the literature

et al. 2010

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Section: Resultsmentioning

confidence: 99%

How is recovery from low back pain measured? A systematic review of the literature

et al. 2010

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“…Primary outcome measure of the study was the Disease Activity Score in 44 joints (DAS). Results were also expressed as percentage of patients in DAS remission (DAS ,1.6), and as percentage of patients having a European League Against Rheumatism (EULAR) good response and American College of Rheumatology (ACR) criteria for 70% improvement (ACR70) response, as specified by the EULAR/ACR recommendations for reporting disease activity in clinical trials (10). Physical functioning was assessed with the Health Assessment Questionnaire (HAQ).…”

Section: Methodsmentioning

confidence: 99%

Effective Treatment for Rapid Improvement of Both Disease Activity and Self‐Reported Physical Activity in Early Rheumatoid Arthritis

Konijn

Tuyl

Boers

et al. 2016

Arthritis Care & Research

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Objective. To investigate the longitudinal relationship between disease activity and self-reported physical activity (PA) in patients with early rheumatoid arthritis during the first year of treatment with combination therapy. Methods. PA was measured with the Short Questionnaire to Assess Health-Enhancing Physical Activity at baseline, 13 weeks, 26 weeks, and 52 weeks after start of treatment in the context of the Combinatietherapie Bij Reumato€ ıde Artritis-Light trial. The reported PA classified patients as meeting or not meeting the World Health Organization (WHO) PA guideline (cutoff: 150 minutes of moderate-to-intense activity per week). Other measurements included the Disease Activity Score (DAS). Since both treatment arms showed equal treatment effect, these were analyzed as 1 group with simple before-after analyses and generalized estimating equations (GEE). Results. In these analyses, 140 patients (86% of the trial population, 66% women, mean age 52 years) with complete data were included. At entry, 69% of the patients met the WHO PA guideline, increasing to 90% at week 13, and remaining stable at 89% after 1 year (P < 0.001). Mean DAS improved from 4.0 to 1.8 during the first year of treatment (P < 0.001). In GEE analyses, DAS decreases were significantly associated with PA increases (P 5 0.008). Patients with clinically relevant responses (expressed as DAS remission, European League Against Rheumatism good response or American College of Rheumatology criteria for 70% improvement response) showed higher PA levels compared to nonresponders, regardless of the definition of response, for both the WHO and Dutch PA guideline. Conclusion. Early rheumatoid arthritis patients using combination therapy improved both disease activity and PA, a beneficial effect persisting for at least 1 year.

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“…Since 2006 there has been an international consensus to measure and report fatigue in all RA clinical trials, in addition to the core set of outcome measures implemented in the 1990s (1,3).…”

Section: Introductionmentioning

confidence: 99%

Predictors of Fatigue in Rheumatoid Arthritis Patients in Remission or in a Low Disease Activity State

Olsen

Lie

Kvien

et al. 2016

Arthritis Care & Research

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ObjectiveFatigue is a frequently occurring symptom in patients with rheumatoid arthritis (RA). Our aims were to assess the level of reported fatigue in RA patients who had achieved remission or low disease activity after 6 months of treatment with disease‐modifying antirheumatic drugs (DMARDs), and to explore associations between fatigue and demographics, disease activity, and other patient‐reported outcomes in this patient group.MethodsA total of 2,193 RA patients (ages ≥18 years) starting either methotrexate (MTX) monotherapy or a tumor necrosis factor inhibitor in combination with MTX were retrieved from the Norwegian Disease‐Modifying Antirheumatic Drugs Register (NOR‐DMARD). At the 6‐month followup, 699 patients (31.9%) were in remission or in a low disease activity state. Bivariate and multivariate linear regression analyses were conducted, with the fatigue visual analog scale (VAS) at 6 months as the dependent variable. Age, sex, disease duration, treatment group, erythrocyte sedimentation rate (ESR), the swollen and tender joint count in 28 joints, the pain VAS score, and disability at baseline and at 6 months were tested as predictors of fatigue at 6 months.ResultsAt 6 months, the median (25th, 75th percentile) level of fatigue was 20.0 mm (6.0, 43.0), and a fatigue VAS score of ≥40 mm was reported by 27.9% of patients. In the multivariate analysis, lower ESR and higher pain at baseline were statistically significant predictors of higher levels of fatigue (P < 0.001). In the multivariate cross‐sectional analysis at 6 months, younger age and greater pain were significantly associated with higher levels of fatigue (P < 0.001).ConclusionPain levels at baseline and at 6 months were associated with a higher level of fatigue. Patients in remission or in a low disease activity state may need nonpharmacologic interventions to manage their pain and fatigue.

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Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations

Abstract: ABSTRACT

Cited by 238 publications

References 14 publications

How is recovery from low back pain measured? A systematic review of the literature

How is recovery from low back pain measured? A systematic review of the literature

Effective Treatment for Rapid Improvement of Both Disease Activity and Self‐Reported Physical Activity in Early Rheumatoid Arthritis

Predictors of Fatigue in Rheumatoid Arthritis Patients in Remission or in a Low Disease Activity State

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