Background Despite the failure of two randomized controlled trials a number of open-label studies and registries suggested the efficacy of rituximab (RTX) in systemic lupus erythematosus (SLE).
Objectives The aim of this observational study is to evaluate efficacy and safety of RTX in patients with SLE, refractory to standard therapy in the context of a daily clinical practice.
Methods From May 2003 until August 2012, 145 SLE patients, 130 female and 15 male, were treated with RTX in 11 Italian Centers. All patients (ACR criteria), were treated with RTX: 118 cases (81.4%) with two infusions (1 g), two weeks apart; 27 cases (18.6%) with 4 infusion (375 mg/m2), one week apart. Age and disease duration were 37.3±12.4 years and 9.0±7.3 years, respectively.
Overall complete response (CR) was defined as European Consensus Lupus Activity Measurement (ECLAM) score ≤1 and partial response (PR) as ECLAM >1 and ≤3. Renal response was defined according to European League of Rheumatism recommendations for management of lupus nephritis. For non-renal involvement response criteria (PR or CR) were based on physician judgment.
Statistical analysis was performed using Pearson's chi-square test and paired or unpaired Student's t tests, when appropriate. All data are expressed as mean ± Standard Deviation.
Results Data of 134 (92.4%) patients were available. Refractory manifestation and clinical response to RTX are summarized in the Table. The follow-up was 19.5±17.5 months.
ECLAM and 24 hours proteinuria decreased (baseline- 12 month follow-up) from 4.1±1.7 to 1.8±1.7 (p<0.0001) and from 4.1±2.9 to 1.1±1.9 g/day (p=0.019), respectively.
Disease flare occurred 16.9±18.8 months after last RTX infusion (range 6-84) in 35.1% of patients, all of them underwent to a second cycle of RTX. After retreatment CR and PR were observed in 57.8% and 26.6% of patients, respectively. Renal flare occurred in 31.2% of patients with previous renal involvement, 19.6±21.7 months after the first RTX cycle (range 6-73). After retreatment renal CR and PR were observed in 60% and 30% of cases, respectively.
Adverse events, infections, and infusion reactions occurred after first RTX course in 23.8%, 16.4%, and 3.8% of patients and after retreatment in 33.3%, 22.2% and 11.1%, respectively; no severe infusion reactions and death occurred during observational period.
Conclusions Data from Italian RTX registry confirmed the efficacy and safety profile of RTX in daily clinical practice in patients with SLE refractory to the standard treatment.
Disclosure of Interest None declared