Lupus & antiphospholipid syndrome
Patient profiles and early response in patients with systemic lupus erythematosus initiating anifrolumab: interim analysis from the ongoing multicentre observational REVEAL study
Authors' conclusion
This study provides the first large-scale real-world evidence of anifrolumab use in patients with SLE, supporting its clinical benefit and rapid onset of action in routine care.
Study context
- Population
- Adults (≥18 years) with systemic lupus erythematosus (SLE), active disease, naive to anifrolumab, consecutively enrolled at first infusion, 25 tertiary rheumatology centres in Italy140 assessed at 6 months
- Participants
- 236 adults
- Outcome
- Number of patients reaching remission (DORIS), LLDAS and LLDAS5 (LLDAS with prednisone-equivalent ≤5 mg/day)
- Follow-up
- 6 months
Methodological detailsmulticentre, pre-specified 6-month interim analysis, 25 tertiary rheumatology centres
- Multicentre
- Pre-specified 6-month interim analysis
- 25 tertiary rheumatology centres
Main finding
As reported in the abstract
Remission (DORIS), LLDAS5 and LLDAS
Remission (DORIS), of 140 patients
37
26%
LLDAS5
80
57%
Lupus Low Disease Activity State (LLDAS)
93
66%
Observational data: associations, not effects.
Further findings
| Outcome | Values |
|---|---|
| Baseline SLEDAI-2K | Anifrolumab median 7 (IQR 6–9) |
Safety
Adverse events during 6-month follow-up
- Adverse events recorded
- 108
- Infections among AEs
- 83 (77%)
Serious adverse events
- Serious adverse events
- 5
- Resulting hospitalisations
- 6
Original publication
Patient profiles and early response in patients with systemic lupus erythematosus initiating anifrolumab: interim analysis from the ongoing multicentre observational REVEAL study. Lancet Rheumatol. Published 5 February 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →