Lupus & antiphospholipid syndrome
Early infection risk in patients with systemic lupus erythematosus treated with rituximab or belimumab from the British Isles Lupus Assessment Group Biologics Register (BILAG-BR): a prospective longitudinal study
Authors' conclusion
In patients with moderate-to-severe SLE, rituximab, belimumab, and standard immunosuppressive therapy have similar serious infection risks.
Study context
- Population
- Patients with moderate-to-severe systemic lupus erythematosus (SLE) in the UK-based BILAG-BR, starting a new biological or standard of care therapy (median age 39 years; 90% women)
- Participants
- 1,048 patients1002.7 person-years
- Exposure
- Rituximab or belimumab vs standard of care
- Rituximabn = 746
- Belimumabn = 119
- Standard of caren = 183reference
- Outcome
- Rate of serious infections within the first 12 months of therapy
- Follow-up
- 12 months
Methodological detailsprospective register, multicentre (64 centres), multiple-failure Cox proportional hazards model
- Prospective register
- Multicentre (64 centres)
- Multiple-failure Cox proportional hazards model
Main finding
As reported in the abstract
Serious infections
Rituximab
92
events
Belimumab
8
events
Standard of care
18
events
Each group vs standard of careAdjusted hazard ratio (CI)
Rituximab
1.68(0.60–4.68)
Belimumab
1.01(0.21–4.80)
- Overall crude incidence rate of serious infection, per 1000 person-years
- 117.7 (95% CI 98.3-141.0)
Observational data: associations, not effects.
Further findings
Risk factors for serious infection, whole cohort (multivariate analysis)
- Prednisolone dose >10 mg, HR
- 2.38 (95% CI 1.47-3.84)
- Hypogammaglobulinaemia <6 g/L, HR (1.38-3.37)
- 2.16
- Multimorbidity, HR (1.17-1.80)
- 1.45
- Additional concomitant immunosuppressive use, HR (0.41-0.90)
- 0.60
Infection-related deaths
- Infection-related deaths, at median 121 days (IQR 60-151) from cohort entry
- 6
Safety
- No significant safety signals regarding atypical infections
Original publication
Early infection risk in patients with systemic lupus erythematosus treated with rituximab or belimumab from the British Isles Lupus Assessment Group Biologics Register (BILAG-BR): a prospective longitudinal study. Lancet Rheumatol. Published May 2023. doi:10.
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