Magnetic resonance imaging RAMRIS-SAFE score-A low-risk effective measure of rapid response to therapy in rheumatoid arthritis clinical trials

Aim: To assess the rapidity of magnetic resonance imaging (MRI) measured synovitis (as measured by synovial thickening using the RAMRIS-SAFE score) and bone edema in active rheumatoid arthritis (RA) subjects treated with golimumab. Secondary aims: to correlate MRI measures with disabilities of the arm, shoulder, and hand (DASH), physician global (PhysG) and patient global (PatG) assessments. Methods: Patients with active RA and inadequate response to methotrexate were recruited. Active RA was defined as RA with a Disease Activity Score of 28 joints -C- reactive protein >= 4.2 at screening AND active disease (synovitis and edema) of the chosen hand or wrist on MRI at screening, as determined by the central blinded MRI reader (PB). Outcomes measures were assessed at baseline, 2, 6, and 12 weeks. MRI results were interpreted by one experienced observer (PB), blinded to clinical measures. Pearson's correlation co-efficient (SPSS) was used to express the relationship between DASH, PhysG, PatG and MRI measures. Results: Eighteen patients were included in the study. All subjects completed follow-up visits and MRI assessment. Mean age was 60.6 years (range 22-72), and 10 were female, 8 male, and disease duration was mean 4.72 years (range 1-28); all patients were taking background methotrexate. The changes in MRI synovial volume were evident by visit 2. The strongest correlations with the DASH for MRI parameters were total synovial thickening (0.923) and edema (0.921). Conclusion: Golimumab was associated with rapid improvement in clinical measures and patient-reported outcome measures. Mean synovial thickening demonstrated early rapid improvement. MRI synovial thickening demonstrated a strong correlation with DASH, PatG and PhysG.