Objectves:To describe the long term clinical outcome and safety profile of B cell depletion therapy (BCDT) in patients with SLE. We also determined if baseline parameters can predict likelihood of disease flare.
Methods:Thirty two patients with refractory SLE were treated with BCDT using a combination protocol (rituximab and cyclophosphamide). Patients were assessed with the BILAG activity index and baseline serology was measured. Flare was defined as a new BILAG ‘A’ or two new subsequent ‘B’s in any organ or system.
Results:Of the 32 patients, 12 have remained well after one cycle of BCDT (median follow up 39 months). BCDT was followed by a decrease of median global BILAG scores from 13 to 5 at 6 months (p = 0.006). Baseline anti-ENA was the only identified independent predictor of flare post BCDT (p = 0.034, odds ratio = 8, 95% CI 1.2 – 55) from multivariable analysis. Patients with low baseline serum C3 had a shorter time to flare post-BCDT (p = 0.008). Four serious adverse events were observed.
Conclusion:Autoantibody profiling may help identify patients who will have a more sustained response. Although the long term safety profile of B cell depletion therapy is favourable, ongoing vigilance is recommended.
- B cell depletion
- long term follow up
- predictors of flare
- systemic lupus erythematosus
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Dr M Leandro has received funding from Roche Pharmaceuticals and GlaxoSmithKline Research and Development Ltd