Evaluation of the Disease Activity Score in Twenty-Eight Joints-Based Flare Definitions in Rheumatoid Arthritis: Data From a Three-Year Clinical Trial.

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)

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:

11 Jul 2017 14:30

Publisher DOI:

10.1002/acr.22633

PubMed ID:

26037777

BORIS DOI:

10.7892/boris.94707

URI:

https://boris.unibe.ch/id/eprint/94707

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