Session Information
Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment: Treatment and Management Studies
Session Type: Abstract Submissions (ACR)
Background/Purpose
Rituximab (RTX), an anti-CD20 chimerical monoclonal antibody, has been used as an off-label in patients with systemic lupus erythematosus (SLE) refractory to standard treatment. Although some small, open label and retrospective studies suggest that RTX might be beneficial in SLE treatment, the two randomized controlled trials of RTX in SLE did not meet the primary endpoints.
The purpose of this work was to assess clinical efficacy and safety of RTX in a cohort of SLE patients treated at a single centre for a long period.
Methods
The authors undertook a retrospective in-depth analysis of all patients (>100) with SLE treated with RTX at a single center between June 2000 and December 2013 and followed for upto 14 years. Data collected included BILAG scores AT and 6, 12, 18 and 24 months after, RTX treatment; anti dsDNA antibody and C3 levels before and 6 months after RTX infusions; adverse events, including allergic/anaphylactic reactions, hypogammaglobulinemia, infections, cardiovascular and cerebrovascular events, and death.
Statistical analysis was performed using Wilcoxon and McNemar nonparametric tests.
Results
A total of 115 patients were reviewed; 93.9% female; 43.5% were Caucasian, 32.2% African and 17.4% South Asian; mean age at diagnosis was 26.39±11.90 years and mean disease duration at first RTX treatment was 91.96±84.80 months. The most frequent indications for RTX treatment were refractory musculoskeletal, renal and mucocutaneous involvement. Mean BILAG score before first RTX treatment was 18.29±10.62; after 6 months, 40% of patients had a complete response (loss of all A’s and B´s and no new A’s or B’s) and 27% had a partial response (partial loss of some but not all A’s or B’s, no new ones.). At 6 months, there was a significant reduction in the BILAG score (p<0.001). Also, 6 months after the first treatment, 36,5% of patients had an increase in C3 levels of 25% and 33.5% had a decrease of over 50% from anti dsDNA antibody baseline level. Depletion of CD19+ cells was successfully achieved in 94% of patients. Hypogammaglobulinemia was detected in 14.9%, however, this reduction was only significant for IgM (p<0.001) and IgG (p=0.001); severe infections, infusion-related and hypersensitivity reactions occurred in 7%, 3.5% and 2.6% of patients, respectively. Of the 115 patients initially treated with RTX, 62 patients had further RTX treatments, maximum of 6, with an average number of 1.95±1.17 cycles per patient and a mean interval between infusions of 21.44±20.11 months. The reason that led to the second RTX treatment was different from the reason leading to the first one in 16 patients, and 25 of the 40 patients who had had partial or complete response at first administration remained partial or complete responders.
At the end of follow-up, 11 patients had died and 6 had cardiovascular events (2 deaths).
Conclusion
In this cohort, RTX treatment was effective in decreasing disease activity and had low incidence of adverse effects.
Disclosure:
R. Aguiar,
None;
A. C. Araújo,
None;
A. L. Papoila,
None;
M. Alves,
None;
D. Isenberg,
None.
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