Objectives: To describe the baseline characteristics of SLE patients requiring biologic therapy in the UK and to explore short term efficacy and infection rates associated with rituximab (RTX) use.

Methods: Patients commencing biologic therapy for refractory SLE and who consented to join BILAG-BR were analysed. Baseline characteristics, disease activity (BILAG 2004/SLEDAI-2K) and rates of infection over follow-up were analysed. Response was defined as loss of all A and B BILAG scores to ⩽ 1 B score with no new A/B scores in other organ systems at 6 months.

Results: Two hundred and seventy SLE patients commenced biologic therapy from September 2010 to September 2015, most commonly RTX (n = 261). Two hundred and fifty (93%) patients were taking glucocorticoids at baseline at a median [interquartile range (IQR)] oral dose of 10 mg (5-20 mg) daily. Response rates at 6 months were available for 68% of patients. The median (IQR) BILAG score was 15 (10-23) at baseline and 3 (2-12) at 6 months (P < 0.0001). The median (IQR) SLEDAI-2K reduced from 8 (5-12) to 4 (0-7) (P < 0.001). Response was achieved in 49% of patients. There was also a reduction in glucocorticoid use to a median (IQR) dose of 7.5 mg (5-12 mg) at 6 months (P < 0.001). Serious infections occurred in 26 (10%) patients, being more frequent in the first 3 months post-RTX therapy. A higher proportion of early infections were non-respiratory (odds ratio = 1.98, 95% CI: 0.99, 3.9; P = 0.049).

Conclusion: RTX is safe and is associated with improvement in disease activity in refractory SLE patients with concomitant reductions in glucocorticoid use. Early vigilance for infection post-infusion is important to further improve treatment risks and benefits.

Original languageEnglish
Pages (from-to)470-479
Number of pages10
Issue number3
Early online date5 Dec 2017
Publication statusPublished - 1 Mar 2018


  • Adult
  • Antirheumatic Agents/administration & dosage
  • Biological Products/administration & dosage
  • Case-Control Studies
  • Female
  • Glucocorticoids/therapeutic use
  • Humans
  • Infection/chemically induced
  • Lupus Erythematosus, Systemic/drug therapy
  • Male
  • Middle Aged
  • Rituximab/administration & dosage
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • United Kingdom

Research Beacons, Institutes and Platforms

  • Lydia Becker Institute
  • Manchester Institute for Collaborative Research on Ageing


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