Lupus & antiphospholipid syndrome
Anifrolumab in systemic lupus erythematosus: real-world evidence from a Spanish multicentre cohort of 206 patients and literature review
Authors' conclusion
In this large RWE cohort, anifrolumab demonstrated early and sustained clinical benefit, a favourable safety profile and a significant corticosteroid-sparing effect.
Study context
- Population
- Patients with systemic lupus erythematosus (SLE) classified according to EULAR/ACR 2019 treated with anifrolumab, 54 Spanish centres
- Participants
- 206 patients54 Spanish centres
- Outcome
- Effectiveness of anifrolumab in clinical practice
Methodological detailsreal-world evidence, review of published observational studies, Data collected from medical records up to 30 April 2025, 183 women; mean age 44.6±12.6 years
- Real-world evidence
- Review of published observational studies
- Data collected from medical records up to 30 April 2025
- 183 women; mean age 44.6±12.6 years
Main finding
As reported in the abstract
- Rapid and sustained improvement in disease activity (SLEDAI-2K, SLE Disease Activity Score (SLE-DAS), Physician Global Assessment (PGA)), Lupus Low Disease Activity State (LLDAS), Definitions of Remission in SLE (DORIS) remission, serological markers (anti-dsDNA, C3/C4) and corticosteroid tapering
- Organ damage remained stable
Observational data: associations, not effects.
Further findings
Most common indications for anifrolumab
- Cutaneous
- 61.7%
- Musculoskeletal
- 48.5%
- Haematological
- 27.2%
Comparison with published observational studies
- Results consistent with published observational studies
Safety
Most frequent AEs (herpes zoster, respiratory infections, headache) · mean follow-up of 7.5±5.3 months
- Herpes zoster
- n= 5
- Respiratory infections
- n= 6
- Headache
- n= 3
Treatment discontinuation
- Patients who discontinued treatment
- 20
Original publication
Anifrolumab in systemic lupus erythematosus: real-world evidence from a Spanish multicentre cohort of 206 patients and literature review. RMD Open. Published 19 March 2026. doi:10.
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