Belimumab safety in adult and paediatric Chinese patients with systemic lupus erythematosus: A Phase 4, multicentre, observational study
Authors' conclusion
Belimumab was generally well tolerated in adult and paediatric patients with SLE in this real-world setting in China, with no new safety signals identified.
Study context
- Population
- Adult and paediatric patients with systemic lupus erythematosus (SLE) prescribed IV belimumab in tertiary hospitals in China, May 2021–May 2022safety population
- Participants
- 417 participants
- Outcome
- Incidence of AEs, SAEs, ADRs and AESIs
- Follow-up
- 24 weeks
Methodological detailsPhase 4, multicentre, real-world
- Phase 4
- Multicentre
- Real-world
Main finding
As reported in the abstract
Incidence of AEs, SAEs, ADRs and AESIs over 24-week follow-up (safety population)
- Patients with adverse events (AEs) (mostly mild, 79.1%)
- 158 (37.9%)
- Patients with serious AEs (SAEs)
- 22 (5.3%)
- Patients with drug-related SAEs (pneumonia, respiratory tract infection, gingivitis and decreased white blood cell and neutrophil count)
- 4 (1.0%)
- Patients with adverse drug reactions (ADRs)
- 25 (6.0%)
- Patients with AEs of special interest (AESIs)
- 14 (3.4%)
- Fatal SAEs
- 0
Observational data: associations, not effects.
Further findings
AEs in paediatric patients (n = 14) · 24 weeks
- Paediatric patients with AEs
- 6
- Paediatric patients with ADRs
- 0
- Paediatric patients with SAEs
- 2
- Paediatric patients with AESIs
- 1
Safety
Most common AEs
- Upper respiratory tract infections
- n = 19, 4.6%
- Hypokalaemia (all mild)
- n = 18, 4.3%
Most common ADR
- Urinary tract infections
- n = 5, 1.2%
AESIs by category
- Infections of interest (all herpes zoster)
- n = 5, 1.2%
- Serious selected psychiatric events
- n = 3, 0.7%
- Infusion-related systemic and anaphylactic reactions
- n = 7, 1.7%
Paediatric patients (14 enrolled)
- AEs
- 6
- ADRs
- 0
- SAEs
- 2
- AESIs
- 1
Original publication
Belimumab safety in adult and paediatric Chinese patients with systemic lupus erythematosus: A Phase 4, multicentre, observational study. Lupus. Published 8 November 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →