Background Although two randomized placebo-controlled trials of rituximab (RTX) in systemic lupus erythematosus (SLE) failed to meet the primary efficacy end point, clinicians continue to use RTX off-label for refractory cases to current treatments.
Objectives We evaluate the effectiveness and safety of rituximab for refractory SLE patients in Korea.
Methods We retrospectively analyzed data of SLE patients treated with RTX which were obtained from eight tertiary rheumatologic clinics in Korea.
Results The total of 39 SLE patients treated with RTX was recruited. They were composed of lupus nephritis 43.6%, hematologic 33.3%, arthritis 7.8%, myositis 7.8%, vasculitis 5.1%, and enteritis 2.6%. All patients had poorly responded to at least one (mean number of immunosuppressive agents, 2.5±1.1) conventional immunosuppressive treatments(cyclophosphamide 43.6%, mycophenolate mofetil 48.7%, azathiopurine 33.3%, and other drugs) before RTX therapy. Clinical improvements (complete remission or partial remission) occurred in 65%, 90%, 100%, 67%, and 67% of patients with renal, hematologic, arthritis, myositis, and other manifestations at 6 month after RTX, respectively. The SLEDAI score was significantly decreased from 10.8±7.1 at baseline to 6.7±4.0 at 6 month, 6.2±4.1 at 12 month, 5.5±3.6 at 24 month, and 6.2±4.3 at 36 month after RTX (p<0.05). Among 28 clinical responders, 4 patients experienced a relapse of disease at 25±4 months. After retreatment with RTX, all these relapsed patients showed the response at 6 month. Infections were noted in 3 patients (7.7%).
Fiqure 1. Response to 6 month after RTX treatment in refractory patients with SLE
Conclusions Our multicenter retrospective analysis suggested that RTX could be effective and relatively safe therapeutic option in patients with severe refractory SLE until new novel B cell depletion therapy is available.
Disclosure of Interest None Declared