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

Lupus Sci MedPublished Observational retrospective study

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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