Abstract

Background:Lupus nephritis (LN) is a potentially life-threatening complication of systemic lupus erythematosus (SLE). Standard treatment of this entity includes glucocorticoids (GC) and immunosuppressants such as cyclophosphamide (CF), with remission rates between 20 and 70%. Given its pathogenesis, the anti-CD20 antibody rituximab (RTX) may be useful, although the information available in the scientific literature remains controversial.Objectives:To evaluate the effectiveness and safety of RTX in NL refractory to conventional treatment, under real clinical practice conditions.Methods:Retrospective descriptive observational study, which included consecutive patients attended in a Rheumatology Unit who met SLICC 2012 criteria for SLE, with renal involvement, and who had received RTX for NL refractory to standard treatment. We collected different epidemiological, clinical (including other manifestations of SLE as well as previous treatments), analytical, RTX-related and adverse event variables. In all cases, renal function prior to the initiation of RTX was determined, as well as the degree of proteinuria and sediment alterations. The therapeutic response was evaluated considering partial response if they presented reduction of proteinuria in >50% compared to initial and stabilization of renal function (± 25%) or improvement of serum creatinine with respect to initial values; and complete response if they presented levels of serum creatinine <1.2mg/dL (or decrease to initial values or ± 15% of the basal value in those with creatinine ≥1,2 mg/dL), proteinuria ≤0,5 g/24h and inactive sediment. A quantitative descriptive analysis has been carried out with the statistical program IBM SPSS 24.0 for Windows.Results:Thirteen patients (11 women and 2 men) were included, with a mean age of 32.3 years and a mean follow-up time from the start of RTX of 11.09 years. Class IV NL was the most frequent (46.15%), followed by Class III NL (38.46%). Class V NL represented 7.69% and another 7.69% the combination of Class III+V. Renal failure was present in 46.2% of patients at the beginning of RTX, 84.6% hematuria and all patients presented proteinuria, of which 76.9% were confirmed to have nephrotic range and 84.6% showed hypoalbuminemia. With regard to previous treatments, all cases had received high-dose of GC and at least one immunosuppressant: 92.3% had failed to CF, a similar percentage had received azathioprine and 46.2% had failed to mycophenolate. After treatment with RTX, partial or complete response was achieved in 84.61%, infections were identified in 46.15% of patients and allergic reactions in 15.38%; most adverse events were mild and all cases developed favorably.Conclusion:RTX treatment is effective in SLE and specifically in LN. More than 80% of patients in our study with refractory LN benefited from RTX treatment. Despite the not insignificant incidence of adverse events, most were mild and resolved without sequels or complications, so we can conclude that the safety of RTX is acceptable and should be considered as a treatment option for these patients according to the good risk-benefit profile.Disclosure of Interests:Consuelo Ramos Giráldez: None declared, Maria Luisa Velloso Feijoo: None declared, Sergio Rodríguez Montero: None declared, Jose Luis Marenco Speakers bureau: ABbvie, Pfzer, lilly

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