FRI0386 Efficacy and Safety of Off-Label Use of Rituximab in Refractory Lupus: Data from the Italian Multicenter Registry. (10th June 2014)

• Record Type: Journal Article
• Authors: Iaccarino, L.; De Vita, S.; Ferraccioli, G.; Galeazzi, M.; Gerli, R.; Govoni, M.; Moroni, G.; Mosca, M.; Roccatello, D.; Tincani, A.; Valesini, G.; Doria, A.
• Is Part Of: Annals of the rheumatic diseases. Volume 73:Supplement 2(2014)
• Page Start: 527
• Page End: 527
• Publication Date: 2014-06-10
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2014-eular.2507
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : 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/m 2 ), 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 DOI: 10.1136/annrheumdis-2014-eular.2507