Dougados, Maxime; Huizinga, Tom W J; Choy, Ernest H; Bingham, Clifton O; Aassi, Maher; Bernasconi, Corrado Angelo (2015). Evaluation of the Disease Activity Score in Twenty-Eight Joints-Based Flare Definitions in Rheumatoid Arthritis: Data From a Three-Year Clinical Trial. Arthritis care & research, 67(12), pp. 1762-1766. Wiley-Blackwell 10.1002/acr.22633
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OBJECTIVE
To assess the flare rate using published criteria (Disease Activity Score in 28 joints [DAS28-2] increase between visits of >1.2 or >0.6 if current DAS28 ≥3.2) in patients receiving constant treatment, and to compare published flare criteria to criteria used by study investigators after biologic treatment discontinuation in the ACT-RAY study.
METHODS
Patients with rheumatoid arthritis (n = 553) were randomized to add tocilizumab to ongoing methotrexate, or switch to tocilizumab plus placebo. If DAS28 ≤3.2 occurred at week 24, treatment remained constant until week 52; here we assessed the DAS28-2 flare rate. Between weeks 52 and 104, patients in sustained remission (DAS28 <2.6 at 2 consecutive visits 12 weeks apart) discontinued tocilizumab and were assessed every 4 weeks. Per protocol, flare was defined as a worsening of disease activity that required treatment beyond the permitted therapy based on investigator opinions (investigator flare) and was compared with the DAS28-2 definition.
RESULTS
After tocilizumab discontinuation, DAS28-2 was sensitive (88-100%), but not specific (57-65%), for detecting investigator flare. Under constant treatment, DAS28-2 criteria were met in 136 cases per 100 patient-years despite stable disease activity. Sustained flares were infrequent. Other DAS28-based criteria led to similar conclusions.
CONCLUSION
DAS28-based flare occurred more often than investigator-defined flares after biologic agent discontinuation. More stringent criteria may be more appropriate for clinical practice.
Item Type: |
Journal Article (Original Article) |
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Division/Institute: |
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology |
UniBE Contributor: |
Bernasconi, Corrado Angelo |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
0893-7524 |
Publisher: |
Wiley-Blackwell |
Language: |
English |
Submitter: |
Stefanie Hetzenecker |
Date Deposited: |
11 Jul 2017 14:30 |
Last Modified: |
05 Dec 2022 15:02 |
Publisher DOI: |
10.1002/acr.22633 |
PubMed ID: |
26037777 |
BORIS DOI: |
10.7892/boris.94707 |
URI: |
https://boris.unibe.ch/id/eprint/94707 |