Background Treatment of childhood systemic lupus erythematosus (SLE) is an ongoing problem because of the severity of the disease in some patients and the side-effects of the currently available immunosuppressive agents. B-cell depletion might be useful and effective treatment for this disease according to researches in adults.
Objectives To assess the clinical and basic serological consequences of rituximab treatment in patients with systemic lupus erythematosus who have failed conventional immunosuppression
Methods An open study of 12 patients with severe SLE followed for a minimum of 6 months is reported. Half of patients (7 out of 12), 12 months follow-up data are described. Disease activity in these patients was assessed every 6 months using the SELENA SLEDAI, System Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index and estimates of anti-double-stranded DNA antibodies and serum C3, C4 levels, number of CD20 B lymphocytes. During the follow-up period, significant side-effects were sought and the reduction in oral prednisolone was recorded too. Background therapy included cyclophosphamide, plasmapheresis, intravenous immunoglobulin, methylprednisolone pulse therapy, mycophenolate mofetil. Rituximab was given 375mg/m2 weekly, №4. All patients were treated with prednisolone and immunosupressive agents.
Results 11 patients were female and 1 male. At the initiation of rituximab treatment the mean age was 14.6 yr (range 10–17.5) and the mean disease duration was 3.6 yr (range 0.3–13.2). 5 had lupus nephritis. All parameters improved from in 6 months after rituximab treatment: the SELENA SLEDAI score from 16 (range 4-25) to 3 (range 0-14) (p=0.002), SLICC/ACR Damage Index from 3,5 (range 0-6) to 2 (range 0-4) (p=0.02), serum C4 from 0,13 (range 0,01-0,9) to 0,24 (range 0.06-1.25) (p=0.04) (normal range 0.14 - 0.47 g/l) and double-stranded DNA binding from 73,5 (range 0-250) to 8,9 (range 0-130) (p=0.04) (normal range 0 - 20 ME/ml) (p=0.05). B-lymphocyte depletion was observed in all patients in the peripheral blood after 6 months (p=0.007). The mean daily prednisolone dose fell from 0.8 mg/kg (range 0.4-1.5) to 0.5 mg/kg (range 0.2-0.8). Proteinuria was improved in 5 patients from 5.6 gr/day (range 0.3-15) to 1.7 gr/day (range 0.3-5.0) (p=0.06). In 12 months rituximab treatment all parameters also improved in 7 patients. There were no flares follow up period. Serious Adverse events were registered: pneumonia (n=2), neutropenia (n=5), herpes Zoster infection (n=2), hypogammaglobulinemia (n=8).
Conclusions In this open study of patients who had failed conventional immunosuppressive therapy, considerable utility in the use of B-cell depletion has been demonstrated. Our data provide strong support for the performance of a full doubleblind control trial.
Disclosure of Interest None Declared
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