Objective: To evaluate the effects of double filtration plasmapheresis (DFPP) in combination with leflunomide and methotrexate (MTX) on magnetic resonance imaging (MRI)-detected inflammatory changes (synovitis and bone edema) in patients with early rheumatoid arthritis (RA) with high disease activity.
Methods: Sixty RA patients with highly active disease of 6 months' to 3 years' duration were randomized to receive DFPP in combination with leflunomide and MTX (DFPP group), and leflunomide plus MTX (no-DFPP group). The primary endpoint was the improvement in MRI-detected synovitis from baseline over 6 months. Secondary endpoint variables included DAS28 remission and American College of Rheumatology (ACR) criteria responses for 6 consecutive months.
Results: The study achieved significant improvement in synovitis and bone edema, with significantly lower synovitis and bone edema scores in the DFPP group compared with the no-DFPP group (p < 0.001). Synovitis scores in 48.39% of patients (15/31) in the DFPP group were 0 at Month 6. Bone edema scores in 32.26% of patients (10/31) in the DFPP group were 0 at Month 6. We observed significantly greater ACR20, ACR50, ACR70, and ACR90 responses and DAS28 remission rates in the DFPP group than in the no-DFPP group (p < 0.001). Sustained DAS28 remission and ACR90 response for at least 6 months were achieved in 100% of patients receiving DFPP therapy.
Conclusion: The combination of DFPP and disease-modifying antirheumatic drugs (DMARD) was superior to DMARD alone for reducing MRI-detected signs of synovitis and bone edema in patients with early highly active RA. DFPP therapy enabled rapid and more complete suppression of inflammation in patients with highly active RA. Nearly half the patients (48.39%) who had received DFPP therapy achieved both clinical remission and imaging remission, a state characterized as true remission.