Background/Purpose: To assess the long term steroid saving capacity and clinical effectiveness of B-cell depletion therapy (BCDT) in newly diagnosed SLE patients.

Methods: Sixteen female SLE patients were treated at, or shortly after diagnosis, with BCDT aiming to minimize the routine use of oral steroids. Post-treatment, most patients were given hydroxychloroquine (n=14) and azathioprine (n=10). The BILAG disease activity index was used for clinical assessment. Serum anti-dsDNA antibodies, complement (C3), ESR, circulating B lymphocytes (CD19+) and total inmmunoglobulins were tested every 2-6 months for an average of 4.5 years (SD 2) post-treatment. Disease activity and steroid requirement over the follow-up period (ranging from 1 to 7 years) were compared with three SLE patients treated conventionally, each carefully matched for ethnicity, sex, age, clinical features, disease duration at diagnosis and length of follow up.

Results: All patients given rituximab achieved B-cell depletion. The mean number of flares during the follow-up period (defined as a new BILAG A or B) was 2.63 (SD 3) in the BCDT group and 4 (SD 3.6) in the control group (NS, p=0.14). Post-BCDT, mean anti- dsDNA antibody level fell from 1,114 U/ml (SD 1,699.3) to 194 (SD 346.7) for 18 months (p= 0.043), mean serum ESR fell by >70% at 6 months maintained during the follow-up and serum C3 level normalized during the follow-up in 8 patients. The mean time to complement normalization was 12.75 months after treatment. At diagnosis, the mean of the Inmunogloblulin G levels in the BCDT group was 17.8 +/- 6.09 g/L and 17.8 +/- 4.3 g/L in the HC (p = 0.98). These values were decreasing progressively to a final average of 10.34 +/- 5.4 g/L in the BCDT group and 12.14 +/- 3 g/L in the HC at 2 years of follow-up and 5.2 +/- 9.35 g/L and 10.2 +/- 2.2 g/L respectively on the fifth year. The mean cumulative prednisolone dose at 60 months for the BCDT patients (n=11) was 4,745.67 mg (SD 6,090 mg) vs 12,553.92 mg (SD 12,672 mg) for the controls (p=0.01). At the end of the follow-up, the SLICC/ACR Damage Index scale showed that the BCDT group had a mean of 1.06 (SD 1.4) and HC a mean of 1.35 (SD 1.5) (p = 0.9).

Conclusion: Early treatment of SLE patients with BCDT is safe, effective and enables a reduction in the overall steroid burden. The accumulated damage in both groups measured by SLICC/ACR Damage Index showed a trend to a lower score in the BCDT group although this did not reach statistical significance. These results support the idea that the use of rituximab as a first-line treatment has similar efficacy to long term conventional treatment but with significantly lower prednisolone dose requirement.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-use-of-rituximab-in-newly-diagnosed-systemic-lupus-erythematosus-patients-long-term-steroid-saving-capacity-and-clinical-effectiveness/