Introduction
Rituximab (RTX) is an alternative for refractory patients with renal SLE, as several open studies support but the only randomized study did not find differences with immunosuppressives. Our objective is to know if RTX is effective for lupus nephritis refractory to immunosuppressive therapy.
Material and methods
We have followed up 46 SLE patients, diagnosed by ACR criteria refractory to immunosuppressive therapy from 3 Spanish hospitals, treated with RTX. The main reason for use of RTX was nephritis in 11 patients (23.9%), arthritis in 13 (28.3%), thrombocytopenia in 5 (10.9%), neurologic involvement in 6 (13%), cutaneous in 6 (13%) and others 5 (10.9%). The dose used in most patients was 2x 1g (86.7%).
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Results
46 patients (6.5% men and 93.5% women). 91.3% Caucasians. The most common dose used was 2x1g (86.7%). The median of cycles was 2 (rank 1-3). Table 1.
Table 1
Endpoints.
Baseline | 24th weeks | Final Visit | |
|---|---|---|---|
Urinary Sediment (%) | 37 | 9.5** | 2.2* |
24-hour urine protein (gr/24h) | 1.2 ± 2.01 | 0.34 ± 0.58** | 0.22 ± 0.38** |
C3 (mg/dl) | 78.17 ± 31.08 | 91.3 ± 31.4** | 101.4 ± 30.8* |
C4 (mg/dl) | 12.52 ± 7.95 | 16.31 ± 7.51** | 19.16 ± 8.74* |
Anti-DNA (UI) | 34.6 (4.85-70.07) | 26.1 (2.12-52.5) | 13 (3.9-34)** |
SLEDAI | 14.5 (7.75-22.25) | 4 (2-6)* | 2 (0-4)* |
Physician´s Global Assessment (PGA) | 2.75 (2.0-3.0) | 0.0 (0.0-1.0)* | 0.0 (0.0-1.0)* |
In 11 renal SLE patients, 8 had complete and 3 partial clinical remission.
Conclusions
RTX have been effective in a group of renal SLE refractory to immunosuppressive therapy (in 8 from 11 refractory renal SLE patients). We are indicating it for SLE patients refractory to conventional therapy, but further studies are necessary to establish its role in the treatment of SLE.
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