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- Title
Evaluation of the Disease Activity Score in Twenty-Eight Joints-Based Flare Definitions in Rheumatoid Arthritis: Data From a Three-Year Clinical Trial.
- Authors
Dougados, Maxime; Huizinga, Tom W. J.; Choy, Ernest H.; Bingham, Clifton O.; Aassi, Maher; Bernasconi, Corrado; Bingham, Clifton O 3rd
- Abstract
<bold>Objective: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusion: </bold>DAS28-based flare occurred more often than investigator-defined flares after biologic agent discontinuation. More stringent criteria may be more appropriate for clinical practice.
- Subjects
ASIA; EUROPE; UNITED States; RHEUMATOID arthritis diagnosis; ANTIRHEUMATIC agents; BIOLOGICAL products; COMBINATION drug therapy; COMPARATIVE studies; DRUG administration; JOINTS (Anatomy); RESEARCH methodology; MEDICAL cooperation; MEDICAL prescriptions; METHOTREXATE; MONOCLONAL antibodies; RESEARCH; RHEUMATOID arthritis; TIME; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; PREDICTIVE tests; DISEASE remission; BLIND experiment; SEVERITY of illness index; DISEASE progression
- Publication
Arthritis Care & Research, 2015, Vol 67, Issue 12, p1762
- ISSN
2151-464X
- Publication type
journal article
- DOI
10.1002/acr.22633