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

Abstract

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.

Prediction of disease relapses by multibiomarker disease activity and autoantibody status in patients with rheumatoid arthritis on tapering DMARD treatment

“…In addition, C reactive protein (CRP) level, ESR and the presence of rheumatoid factor (RF) as well as ACPA were measured. Composite scores including DAS28-ESR, DAS28-CRP, ACR/EULAR Boolean remission 16 and Health Assessment Questionnaire (HAQ-DI) were calculated at baseline and each follow-up visit, Antirheumatic therapy and any other concomitant treatment were recorded at baseline and at follow-up visits.…”

Value of ultrasonography as a marker of early response to abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results from the APPRAISE study

“…The score has demonstrated validity and intraobserver and interobserver reliability in cross-sectional datasets, applicability to all joints and consistency between machines. [21][22][23][24] This report presents data from the first prospective international study designed to assess the capability of the composite PDUS score to measure the early effect and time course of response to treatment with abatacept in biologic-naïve patients with active RA despite methotrexate (MTX). The primary objective of this study was to investigate the responsiveness of the composite PDUS score, as defined by an improvement in the global score (Global OMERACT-EULAR Synovitis Score, or GLOESS) of the bilaterally evaluated second to fifth metacarpophalangeal joints (MCPs 2-5).…”

Using Dermal Temperature to Identify Rheumatoid Arthritis Patients With Radiologic Progressive Disease in Less Than One Minute

“…This 1‐year parallel‐group observational study enrolled seropositive (RF‐positive and/or CCP‐positive) patients who met the 1987 American College of Rheumatology (ACR) revised criteria and the 2011 European League Against Rheumatism criteria for RA 8, 9. Patients stable for 3 months or more on methotrexate (20–25 mg/week) and folate supplements (1 mg/day) were eligible for the observational study and were permitted to use corticosteroid therapy (up to 5 mg/day of prednisone) and nonsteroidal antiinflammatory drugs.…”