Background/Purpose: Remission by Boolean-based definition (all scores on the tender joint and swollen joint count, CRP (mg/dL), and patient global assessment ≤1) and by Simplified Disease Activity Index-based definition (SDAI, <3.3) were proposed by ACR/EULAR. Using patient reported outcomes as anchors, this analysis validated these remission criteria against traditional Disease Activity Score (DAS28) using CRP remissions (<2.6) in 3 RA patient populations.

Methods: The efficacy of golimumab (GLM) was assessed in methotrexate (MTX)-naïve RA patients (GO-BEFORE, N=637), RA patients with inadequate response to MTX (GO-FORWARD, N=444) and RA patients previously treated with biologic anti-TNFα agent(s) with baseline MTX use (GO-AFTER, N=305). Pooled data from patients who received placebo (PBO) + MTX, or GLM (50 or 100mg) + MTX, q4 weeks were used for this analysis.  Patient reported outcomes were measured with the following: Health Assessment Questionnaire (HAQ), Physical and Mental Component Summary Scores of 36-item short-form health survey (SF36 PCS and MCS), Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), and a Visual Analogue Scale (VAS, 0-10) of impact of RA on daily work productivity. Descriptive statistics were provided forpatient reported outcomes among patients in remission as defined by the 3 remission definitions.

Results: Greater proportions of patients treated with GLM + MTX vs patients treated with PBO + MTX achieved remission in the 3 studies by each remission definition.  In the pooled analysis, the remission rate at wk 24 was the highest (20.2%) by DAS28, compared to remission by SDAI (10.6%, p<0.001) and remission by Boolean-based definition (8.6%. p<0.001). Patients with remission by DAS28 achieved normal physical function (HAQ≤0.5), normal SF-36 PCS, and MCS (≥50) by 67.8%, 38.4%, 62.2%, respectively; these parameters were numerically lower when compared to patients with remission by SDAI (81.3%, 62.8%, 72.1%, respectively) or by Boolean-based definition (82.0%, 63.5%, 74.3%, respectively). Patients in remission by DAS28 had higher HAQ scores (0.43 ±0.49) compared to patients in remission by SDAI (0.26±0.41) or Boolean-based criteria (0.28±0.44).  Similar results were observed in measures of FACIT-fatigue and productivity VAS scores. Among MTX-naive patients in the GO-BEFORE study who achieved remission by DAS28, 71.3% achieved normal physical function compared to 86.9% of those in remission by SDAI and 86.5% of patients in remission by Boolean-based definition. Among anti-TNFα experienced patients in the GO-AFTER study, 62.1% of those in remission by DAS28 achieved normal physical function compared to 65.0% of those in remission by SDAI, and 66.7% of patients in remission by Boolean-based definition.

Conclusion: While disease remission has been adapted as a target in the management of RA, more stringent remission criteria proposed by ACR/EULAR can provide optimal patient-reported outcomes.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/validation-of-remission-of-rheumatoid-arthritis-by-traditional-disease-activity-score-and-provisional-criteria-by-american-college-of-rheumatology-and-european-league-against-rheumatism-patient-repor/