Lupus & antiphospholipid syndrome
Efficacy of belimumab in patients with SLE and haematological manifestations: retrospective analysis from the BeRLiSS 2.0 cohort
Authors' conclusion
In this real-world cohort, BEL treatment was associated with improvement in anaemia, thrombocytopenia, lymphopenia and leucopenia with over half of patients achieving normalisation of blood counts.
Study context
- Population
- Patients with SLE treated with belimumab for active joint or skin involvement, 14 Italian referral centres, June 2013–May 2024, with baseline haematological abnormalities
- Participants
- 76 / 44 / 107 / 53
- Exposure
- Anaemia vs Thrombocytopenia vs Lymphopenia vs Leucopenia
- Anaemian = 76
- Thrombocytopenian = 44
- Lymphopenian = 107
- Leucopenian = 53
- Outcome
- Improvement in anaemia, thrombocytopenia, lymphopenia and leucopenia (Hb, Plts, Lym, Leuc)
- Follow-up
- Up to month 48
Methodological detailsmulticentre, real-world
- Multicentre
- Real-world
Main finding
As reported in the abstract
Blood counts, baseline to month 48
- Haemoglobin (Hb): 9.9±0.6 g/dL to 11.7±1.4 g/dL (p<0.001)
- Platelets: 110.2±38.1×109/L to 176.6±88.7×109/L (p=0.004)
- Lymphocytes (Lym): 0.72±0.21×109/L to 1.14±0.45×109/L (p<0.001)
- Leucocytes: 2.437±0.533×109/L to 4.732±1.897×109/L (p<0.001)
- Follow-up to month 48: 33 anaemia, 20 thrombocytopenia, 44 lymphopenia, 18 leucopenia
Observational data: associations, not effects.
Further findings
Improvement by concomitant immunosuppressant use
- Similar regardless of concomitant immunosuppressants: Hb (p=0.97), platelets (Plts) (p=0.12), Lym (p=0.86), leucocytes (Leuc) (p=0.73)
Glucocorticoid (GC) dose (mg/day) · up to month 48
- Anaemia: 12.9±12.1 to 3.6±4.9 mg/day, p=0.003
- Thrombocytopenia: 10.8±9.6 to 4.4±5.5 mg/day, p=0.004
- Lymphopenia: 10.6±8.6 to 3.1±3.2 mg/day, p<0.001
- Leucopenia: no significant decrease
Proportion of GC users · 48 months
- Anaemia
- 96.1-60.7%
- Thrombocytopenia
- 93.1-80%
- Lymphopenia
- 96.3-70.3%
- Leucopenia
- 95.3-80%
Original publication
Efficacy of belimumab in patients with SLE and haematological manifestations: retrospective analysis from the BeRLiSS 2.0 cohort. Lupus Sci Med. Published 4 May 2026. doi:10.
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