Background A single “gold standard” measure such as blood pressure or serum glucose is not available in rheumatoid arthritis (RA) for diagnosis and monitoring of all individual patients. A Core Data Set of 7 measures has been developed for RA, with 3 measures from a physician - tender (TJC) and swollen joint count (SJC), assessor global (DOCGL); 1 laboratory test - erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP); 3 from a patient questionnaire - function (HAQ-FN), pain (PAIN), and patient global estimate (PATGL), all 7 measures, including patient-reported measures, have similar relative efficiencies to distinguish active from control treatment in reported clinical trials of methotrexate, leflunomide, adalimumab, abatacept, and certolizumab1.
Objectives To analyze standardized response means (SRM) and relative efficiencies of each of the 7 RA core data set measures in the treat-to-target GUEPARD clinical trial versus the routine care ESPOIR cohort.
Methods Post-hoc analyses were performed on 2 databases of patients with RA: 65 patients from GUEPARD with tight control, and 130 matched patients from ESPOIR with routine care2. Each of the 7 RA Core set measures was computed in each patient at baseline and 6 months later, and changes in the two cohorts were compared using Student’s t tests. Standardized response mean (SRM) and relative efficiencies with TJC as the referent measure were computed.3
Results Baseline demographic and clinical characteristics did not differ between the 2 groups, other than disease duration (5.6 months in GUEPARD tight control versus 3.5 months in ESPOIR routine care groups) and higher use of glucocorticoids, biological agents, and mean glucocorticoid dose in the GUEPARD tight control trial. Substantial improvement was seen in both groups, but was significantly greater in GUEPARD tight control for all RA Core Data set measures other than ESR and CRP. The highest SRMs of >4 were observed for pain, and patient and physician global estimates (Table) compared to 1-3 for TJC, SJC, and HAQ function, and <0.2 for ESR and CRP.
Conclusions Patient self-report measures document better results in GUEPARD tight control versus ESPOIR routine care as efficiently as TJC and SJC, and more efficiently than laboratory tests.
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Disclosure of Interest None Declared