Background/Purpose:   Systemic lupus erythematosus (SLE) is an autoimmune disease with diverse clinical and serological manifestations. B-cell-targeted therapies have been promising new treatments for SLE. Despite the failure of randomized controlled trials, a considerable number of studies report good clinical efficacy of Rituximab, an anti-CD20 monoclonal antibody, in patients with SLE. Herein, we aimed to analyse the effects of Rituximab in lupus patients with involvement of different domains.

Methods:   This a retrospective analysis of 79 lupus patients treated with rituximab at the rheumatology outpatient clinic. Disease activity was assessed using SLE disease activity index (SLEDAI) and treatment response was defined according to the system involved: A partial response was defined as ≥ 50% improvement in renal parameters, in cutaneous lesions or vasculitis, in the number of painful and/or swollen joints, increase in hemoglobin by at least 2 g/dl, doubling of basal platelet levels or platelet count between 50-100×10⁹/mm³. A complete response was defined as proteinuria<0.5/day, normal urinary sediment, normal hemoglobin levels, >100×10⁹/mm³ platelets, disappearance of cutaneous manifestations or arthritis. For patients with general disease activity a reduction of SLEDAI score at least by half was defined as partial and a score ≤2 as complete response.

Results:   Cyclophosphamide(Cy) was used in 64% of the patients as previous treatment, mycophenolate mofetil(MMF) in 62%, azathioprine(AZA) in 63%, methotrexate(MTX) in 23%, calcineurin inhibitors(CNI) in 5%, leflunomide in 4% and intravenous immunoglobulin in 5% of the patients. Treatment response at 6 months revealed a complete response in 27%, 60%, 67%, 43% and 88% in patients with lupus nephritis (LN), thrombocytopenia/AIHA, arthritis, vasculitis and general disease activity respectively. In the LN group there were more partial and non responders compared to other domains. 50% of those patients went into remission and mean time to remission was 10+/-1.7 months. Concomitant treatment with Rituximab included MMF in 46, %, AZA in 13%, CNI in 5% and MTX in 10 % of patients. Comparison of treatment response between proliferative and membranous subtypes of LN revealed a a significantly higher number of complete responders (CR) in class IV whilst there were no CR among patients with membranous nephritis at the 6^thmonth of treatment. Comparison of baseline mean SLEDAI scores, antidsDNA positivity rate, C3 levels and mean daily steroid dose to 6th month of treatment favored rituximab use. Overall there were 9 infusion reactions: angioneurotic edema in 4, serum sickness in 2, rhabdomyolysis and fever in 1, urticarial rash and fever in 1 and thrombocytopenia in 1. 4 patients had zona zoster, 3 pneumonia, 3 urinary tract infections, 1 infective endocarditis and 1 tooth abscess. 3 needed to be hospitalized and 2 received intravenous immunoglobulin.

Conclusion:   Regardless of the discouraging results of randomized controlled trials with Rituximab in lupus patients, our clinical experience also shows that it still remains as a therapeutic option, especially in severe and refractory cases. 

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-singlecenter-experience-of-rituximab-treatment-in-86-patients-with-systemic-lupus-erythematosus/