EFFICACY AND SAFETY OF RITUXIMAB IN CHILDREN WITH SYSTEMIC LUPUS ERYTHEMATOSUS: RESULTS OF A RETROSPECTIVE STUDY OF THE CASE SERIES

Abstract

Background. Blocking of B lymphocytes producing autoantibodies in systemic lupus erythematosus (SLE) may be an effective strategy for pathogenetic treatment, including in children. Objective: Our aim was to assess the efficacy and safety of rituximab treatment (chimeric monoclonal antibodies to CD20) in children with severe SLE refractory to glucocorticosteroids and immunosuppressants. Methods. We studied the case histories of children with SLE admitted to the rheumatology department of the SCCH between 2004 and 2013. The treatment results were assessed by the SELENA SLEDAI Disease Activity Index, Damage Index scale, and dynamics of the values of laboratory disease activity indices. Results. We analyzed the results of rituximab treatment in 12 patients for 24 weeks, 11 of them — for 48 weeks. The preparation was administered intravenously at a dose of 375 mg/m 2 of the body surface area to administer 4 times weekly (n = 10) or 2 times with an interval of 2 weeks ( n = 2). After 48 weeks of rituximab treatment, SELENA SLEDAI index values decreased from 16 (11, 21) to 1 (0, 2) (p < 0.001), Damage Index — from 3.5 (1.0, 5.0) to 1.0 (0.0, 3.0) (p = 0.024), complement component C4 concentration increased from 0.13 (0.04, 0.19) to 0.43 (0.18, 0.50) g/l (p = 0.017), the number of antibodies to double-stranded DNA decreased from 73.5 (11.5, 245.0) to 1.9 (0.0, 40.0) IU/ml (p = 0.004). Depletion of B lymphocytes was recorded in all patients after 24 and 48 weeks of rituximab treatment. Prednisolone dose was reduced from the initial 0.80 (0.43, 1.00) mg/kg per day to 0.20 (0.17, 0.30) after 48 weeks (p = 0.025). Disease exacerbations during 48 weeks have not been reported. Such serious adverse events as pneumonia ( n = 2), neutropenia ( n = 5), Herpes zoster infection ( n = 2), hypogammaglobulinemia ( n = 8) were noted. Conclusion. High efficacy and satisfactory risk-benefit profile of rituximab treatment in children with severe SLE refractory to glucocorticosteroids and immunosuppressants have been shown.