scholarly journals American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials

2011 ◽  
Vol 70 (3) ◽  
pp. 404-413 ◽  
Author(s):  
David T Felson ◽  
Josef S Smolen ◽  
George Wells ◽  
Bin Zhang ◽  
Lilian H D van Tuyl ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Disease Activity ◽  
Functional Outcomes ◽  
Outcome Measure ◽  
American College Of Rheumatology ◽  
European League Against Rheumatism ◽  
Core Set ◽  
Patient Reported ◽  
Definition Of ◽  
European League

ObjectiveRemission in rheumatoid arthritis (RA) is an increasingly attainable goal, but there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome measure in clinical trials. This work was undertaken to develop such a definition.MethodsA committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism, and the Outcome Measures in Rheumatology Initiative met to guide the process and review prespecified analyses from RA clinical trials. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures including, as a minimum, joint counts and levels of an acute-phase reactant to define remission. Members were surveyed to select the level of each core set measure that would be consistent with remission. Candidate definitions of remission were tested, including those that constituted a number of individual measures of remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analysed to examine the added contribution of patient-reported outcomes and the ability of candidate measures to predict later good radiographic and functional outcomes.ResultsSurvey results for the definition of remission suggested indexes at published thresholds and a count of core set measures, with each measure scored as 1 or less (eg, tender and swollen joint counts, C reactive protein (CRP) level, and global assessments on a 0–10 scale). Analyses suggested the need to include a patient-reported measure. Examination of 2-year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good radiographic and functional outcomes, although 28-joint Disease Activity Score–based measures of remission did not predict good radiographic outcomes as well as the other candidate definitions did. Given these and other considerations, we propose that a patient's RA can be defined as being in remission based on one of two definitions: (1) when scores on the tender joint count, swollen joint count, CRP (in mg/dl), and patient global assessment (0–10 scale) are all ≤1, or (2) when the score on the Simplified Disease Activity Index is ≤3.3.ConclusionWe propose two new definitions of remission, both of which can be uniformly applied and widely used in RA clinical trials. The authors recommend that one of these be selected as an outcome measure in each trial and that the results on both be reported for each trial.

scholarly journals The American college of rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials

1993 ◽  
Vol 36 (6) ◽  
pp. 729-740 ◽  
Author(s):  
David T. Felson ◽  
Jennifer J. Anderson ◽  
Maarten Boers ◽  
Claire Bombardier ◽  
Miriam Chernoff ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Disease Activity ◽  
American College Of Rheumatology ◽  
Core Set ◽  
Activity Measures ◽  
Disease Activity Measures

scholarly journals POS0707 SALIVARY GLAND ULTRASONOGRAPHY AND THE CLINICAL FEATURES USING ESSDAI IN PATIENTS OF EARLY-ONSET VERSUS LATE-ONSET WITH PRIMARY SJÖGREN’S SYNDROME

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 603.1-603
Author(s):  
N. Hashimoto ◽  
S. Uchiyama ◽  
T. Nakazawa ◽  
T. Iwasaki ◽  
T. Hashimoto
Keyword(s):  
Nervous System ◽  
Salivary Gland ◽  
Disease Activity ◽  
Early Onset ◽  
Late Onset ◽  
Primary Sjögren’S Syndrome ◽  
Onset Age ◽  
Primary Sjogren’S Syndrome ◽  
European League Against Rheumatism ◽  
European League

Background:Primary Sjögren’s syndrome (pSS) is a chronic inflammatory autoimmune disease characterized by lymphocyte infiltration in salivary and lacrimal glands. pSS affects primarily middle-aged and elderly patients, although younger age groups may also be involved. However, differences of etiology and pathogenesis between early-onset pSS (EOpSS) and late-onset pSS (LOpSS) are unknown. Recently, standardized outcome tools for measuring disease-specific activity and patients’ reported symptoms have been formulated by the European League Against Rheumatism (EULAR) SS study group: the EULAR SS Disease Activity Index (ESSDAI) for systemic features of pSS [1]. Also, as the new imaging techniques, salivary gland ultrasonography (SGUS) proved valuable for assessing salivary gland involvement in SS and seemed to exhibit good diagnostic properties. In addition, previous studies have demonstrated usefulness of SGUS for the prognostic stratification of patients with pSS [2], [3], [4].Objectives:The aim of this study was to examine the differences of etiology and pathogenesis between EOpSS and LOpSS using ESSDAI and SGUS.Methods:Fifty-six pSS patients who fulfilled the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria for SS were studied. Based on the disease onset age, all pSS patients were divided into two groups as those with the onset age of 40 years old or younger (EOpSS: n=26) and those with the onset age of older than 65 years old (LOpSS: n=30). The clinical findings were evaluated ESSDAI and OMERACT SGUS score at the first visit to our hospital. The ESSDAI (0–123) proposes the evaluation of 12 domains or organ systems (constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, peripheral nervous system, central nervous system, muscular, hematological and biology). All patients were examined SGUS by a single investigator who was blinded to device (TUS-A300; Canon Medical Systems, Tokyo, Japan) with a linear transducer (7.5-10MHz). The OMERACT SGUS score was used for graded changes in the parenchymal homogeneity of salivary glands: grade 0, normal-appearing salivary gland parenchyma; grade 1, minimal change: mild inhomogeneity without hypo/anechoic areas; grade 2, moderate change: moderate inhomogeneity with focal hypo/anechoic areas; grade 3, severe change: diffuse inhomogeneity with hypo/anechoic areas occupying the entire gland surface [5].Results:The proportions of positive sera of RF, anti-SS-A and anti-SS-B antibodies were not different in the two groups, but the disease activities were higher in the EOpSS than in the LOpSS patients by measuring ESSDAI (7.30 vs 4.23, p=0.008), especially in constitutional domain (1.50 vs 0.60, p=0.03), articular domain (1.54 vs 0.40, p=0.0002) and biological domain (1.35 vs 0.90, p=0.04). No difference in salivary secretion was found between two groups (EOpSS: 8.02 vs LOpSS: 6.31 mL/10min.), but the OMERACT SGUS score was higher in LOpSS than in EOpSS patients (2.00 vs 2.70, p=0.0002).Conclusion:Although serological findings were not different, EOpSS patients had higher disease activity but less severe salivary gland degeneration than that in LOpSS patients, suggesting the pathogenesis of these two groups was different.References:[1]Seror R, et al. Ann Rheum Dis. 2010 Jun;69(6):1103-9.[2]Arthritis Care Res (Hoboken). 2014 Jul;66(7):1102-7.[3]Hammenfors DS, et al. Clin Exp Rheumatol. 2015 Jan-Feb;33(1):56-62.[4]Milic V, et al. PLoS One. 2019 Dec 31;14(12): e0226498.[5]Jousse-Joulin S, et al. Ann Rheum Dis. 2019 Jul;78(7):967-973.Disclosure of Interests:None declared

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