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Abstract
Background Previous reports indicate that treating patients with lupus (SLE) at or close to the time of diagnosis successfully without using any, or minimal, corticosteroids by using B-cell depletion (BCD) is possible in the short-term. It is not however known whether using BCD is as effective or reduces corticosteroid use in the long-term. We report the long-term (up to 7 years) use of BCD with respect to its steroid-saving capacity and clinical effectiveness in newly diagnosed SLE.
Methods Sixteen female patients with SLE were treated at, or shortly after diagnosis, with BCD therapy (BCDT) minimising the routine use of oral steroids. Post-treatment, most patients were given hydroxychloroquine (n=14) and azathioprine (n=10). The British Isles Lupus Assessment Group (BILAG) disease activity index was used for clinical assessment. Serum antidouble-stranded DNA (dsDNA) antibodies, complement (C3), erythrocyte sedimentation rate (ESR), circulating B lymphocytes (CD19+) and total inmmunoglobulins were tested every 2–6 months (average of 4.5 years) (SD 2) post-treatment. Disease activity and steroid requirement were compared with three patients with SLE treated conventionally, each matched for ethnicity, sex, age, clinical features, disease duration at diagnosis and follow-up period.
Results All patients given rituximab achieved BCD. The mean number of flares during follow-up (new BILAG A or B) was 2.63 (SD 3) in the BCDT group and 4 (SD 3.6) in the controls (NS, p=0.14). Post-BCDT, mean anti-dsDNA antibody level fell from 1114 U/mL (SD 1699.3) to 194 (SD 346.7) at 18 months (p=0.043), mean serum ESR fell by >70% at 6 months maintained during follow-up and serum C3 level normalised in 8 patients. The mean cumulative prednisolone dose at 60 months for the patients who underwent BCDT (n=11) was 4745.67 mg (SD 6090 mg) vs 12 553.92 mg (SD 12 672 mg) for the controls (p=0.01).
Conclusions Early treatment of patients with SLE with BCDT is safe, effective and enables a reduction in steroid use.
- B cells
- Systemic Lupus Erythematosus
- DMARDs (biologic)
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Footnotes
Contributors DI conceived the project, reviewed the cohort to identify the disease controls, reviewed the data and helped to write the manuscript. BG-T was involved in early discussions of the project, did much of the data collection and writing the first draft of the manuscript and AE was involved in early discussions of the manuscript, some of the data collection and writing the first draft of the manuscript. All authors read and approved the manuscript.
Funding The authors DI and AE are supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre.
Competing interests None declared.
Ethics approval The use of B-cell depletion in these patients was approved by the hospital's Use of Medicines committee, which considers all aspects of treatment proposed including ethical issues. All patients gave informed consent to the BCD treatment.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement We have included all the available data in the article as sent to the journal.