Lupus & antiphospholipid syndrome
Characteristics and clinical outcomes of patients with systemic lupus erythematosus initiating anifrolumab in a real-world setting in Spain (AZAHAR study): an observational study protocol
Study context
- Population
- Adults with moderate-severe systemic lupus erythematosus (SLE) initiating anifrolumab during its first year of marketing in Spain, 20 centresplanned
- Participants
- ≈120 adults
- Primary endpoint
- Disease activity (Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000, clinical SLEDAI, PGA), LLDAS and remission (DORIS-21)
- Follow-up
- Every 6 months for 6–18 months
Methodological detailsstudy protocol, multicentre, 20 centres, medical record review, Follow-up every 6 months after first anifrolumab infusion for 6–18 months, until 31 December 2024
- Study protocol
- Multicentre
- 20 centres
- Medical record review
- Follow-up every 6 months after first anifrolumab infusion for 6–18 months, until 31 December 2024
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Characteristics and clinical outcomes of patients with systemic lupus erythematosus initiating anifrolumab in a real-world setting in Spain (AZAHAR study): an observational study protocol. Lupus Sci Med. Published 12 February 2025. doi:10. 1136/ lupus-2024-001486
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