Use of Rituximab in Systemic Lupus Erythematosus: A Single Center Experience Over 14 Years.
OBJECTIVE
To describe the clinical outcome and safety of rituximab (RTX) treatment in systemic lupus erythematosus (SLE) patients with severe manifestations or whose disease is refractory to standard immunosuppressive therapy, treated at a single center.


METHODS
This was a retrospective analysis of all patients with SLE treated with RTX at 1 center between June 2000 and December 2013. The clinical outcome was assessed by determining British Isles Lupus Assessment Group (BILAG) scores and anti-double-stranded DNA (anti-dsDNA) and C3 levels before and 6 months after RTX treatment. For safety analysis, adverse events and deaths were recorded.


RESULTS
Of a total of 115 patients, 93.9% were female, the mean ± SD age at diagnosis was 26.39 ± 11.90 years, and the mean ± SD disease duration at first RTX treatment was 91.96 ± 84.80 months. A BILAG score variation of -11.26 ± 11.38 (P < 0.001) was recorded 6 months after the first RTX treatment; 40% of patients had a complete response and 27% had a partial response; in 36.5% of patients, C3 levels increased more than 25%, and in 33.5% anti-dsDNA levels decreased more than 50%. Depletion of CD19+ cells was achieved in 94.0% of patients. Hypogammaglobulinemia was detected in 14.9% of patients, with significant reduction for IgM (P < 0.001) and IgG (P = 0.001) levels. Severe infections, infusion-related reactions, and hypersensitivity reactions occurred in 7%, 3.5%, and 2.6% of patients, respectively. Of the 115 patients, 62 patients had repeated RTX treatments, with an average number of 1.95 ± 1.17 cycles per patient and a mean ± SD interval between infusions of 21.44 ± 20.11 months. At the end of followup, 11 patients were deceased; 6 had cardiovascular events.


CONCLUSIONS
RTX treatment was effective in decreasing disease activity, with a low incidence of adverse effects.
Centro Hospitalar do Baixo Vouga EPE, Aveiro, Portugal.
R
R
Aguiar
Hospital de Curry Cabral, Centro Hospitalar de Lisboa Central EPE, Lisbon, Portugal.
C
C
Araújo
Baixo Vouga Group of Primary Care Centers and University of Porto Medical School, Porto, Portugal.
G
G
Martins-Coelho
Centre for Rheumatology Research, University College of London Hospital, London, UK.
D
D
Isenberg
D000328:Adult; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D000069283:Rituximab / Q000627:therapeutic use*
D007155:Immunologic Factors; D000069283:Rituximab