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Table 5 EULAR/ACR collaborative recommendations for disease activity reporting in clinical trials

From: Outcome measures in inflammatory rheumatic diseases

Point Description
1 Each trial should report the disease activity response and disease activity states
1a Response: ACR (ACR20, ACR50, ACR70: ideally also ACR Hybrid, after successful prospective validation in clinical trials) and EULAR response criteria (good, moderate and non-responders)
1b States: composite measures of disease activity should be used as outcome measures and with cut-off points to define various disease activity states: they include DAS/DAS28, CDAI, and SDAI; appropriate descriptive statistics of the baseline, the endpoint and change of the composite indices should be reported
2 Each trial should report the appropriate descriptive statistics of the baseline, the endpoint, and change of the single variables included in the core set
3 Each trial should report the baseline disease activity levels
4 Each trial should report the percentage of patients achieving a low disease activity state and remission
4a Definitions that should be used for low disease activity include cut-off points for low disease activity for DAS/DAS28, CDAI, SDAI, and MDA
4b Definitions that could be used for remission include preliminary ARA remission criteria and respective cut-off points for DAS/DAS28, CDAI, and SDAI
5 Each trial should report the time to onset of the primary outcome (a particular response or a certain disease activity state)
6 Each trial should consider and report the sustainability of the primary outcome (as opposed to evaluating it at a single predefined time point during the trial)
7 Each trial should report on fatigue
  1. ACR, American College of Rheumatology; ARA, American Rheumatism Association; CDAI, Clinical Disease Activity Index; DAS, Disease Activity Score; EULAR, European League Against Rheumatism; MDA, Minimal Disease Activity; SDAI, Simplified Disease Activity Index. Reprinted from [41] with permission of John Wiley & Sons, Inc.