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Short-term efficacy and safety of rituximab therapy in refractory systemic lupus erythematosus: results from the British Isles Lupus Assessment Group Biologics Register

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McCarthy EM1, Sutton E2, Nesbit S2, White J2, Parker B1,3, Jayne D4, Griffiths B5, Isenberg DA6, Rahman A6, Gordon C7,8, D'Cruz DP9, Rhodes B10, Lanyon P11, Vital EM12,13, Yee CS14, Edwards CJ15,16, Teh LS17, Akil M18, McHugh NJ19,20, Zoma A21, Bruce IN1,2. Rheumatology (Oxford). 2017 Dec 5. doi: 10.1093/rheumatology/kex395. [Epub ahead of print]

Abstract

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1 The Kellgren Centre for Rheumatology, NIHR Manchester Musculoskeletal Biomedical Research Unit, Central Manchester University Hospitals NHS Foundation Trust.

2 Arthritis Research UK Centre for Epidemiology.

3 Division of Musculoskeletal & Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester.

4 Department of Medicine, Addenbooke's Hospital, Cambridge.

5 Department of Rheumatology, Freeman Hospital, Newcastle upon Tyne.

6 Division of Rheumatology, University College London, Rayne Institute, London.

7 Rheumatology Research Group, Institute of Inflammation and Ageing, University of Birmingham.

8 Rheumatology Department, City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham.

9 Louise Coote Lupus Unit, Guys Hospital, London.

10 Rheumatology Department, University Hospitals Birmingham NHS Foundation Trust, Old Queen Elizabeth Hospital, Birmingham.

11 Rheumatology Department, Nottingham University Hospitals NHS Trust, Nottingham.

12 Leeds Institute for Rheumatic and Musculoskeletal Medicine, University of Leeds.

13 NIHR Leeds Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds.

14 Department of Rheumatology, Doncaster and Bassetlaw Hospitals NHS Foundation Trust, Doncaster.

15 Musculoskeletal Research Unit, NIHR Wellcome Trust Clinical Research facility, The University of Southampton.

16 Department of Rheumatology, University Hospital Southampton NHS Foundation Trust, Southampton.

17 Department of Rheumatology, Royal Blackburn Hospital, Blackburn.

18 Rheumatology Department, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust.

19 Department of Rheumatology, Royal National Hospital for Rheumatic Diseases and Royal United Hospitals Bath NHS Foundation Trust.

20 Department of Pharmacy and Pharmacology, University of Bath, Bath.

21 Rheumatology Department, Hairmyres Hospital, Lanarkshire, UK.

Abstract

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.