Lupus & antiphospholipid syndrome
Real-world experience of anifrolumab treatment in patients with moderate-to-severe SLE: a retrospective study of patients in early access programmes
Authors' conclusion
Based on the changes in disease activity and attainment of DORIS remission and LLDAS seen within 6 months of anifrolumab initiation, this study supports anifrolumab use in a real-world population of patients with moderate to severe SLE.
Study context
- Population
- Adults with moderate-to-severe SLE initiating anifrolumab in routine clinical practice through two early access programmes41 ongoing at study end
- Participants
- 47 adults
- Exposure
- Anifrolumab 300 mg IV every 4 weeks alongside standard therapy; baseline vs 6 months
- Anifrolumabn = 47
- Outcome
- Disease activity and remission/LLDAS, baseline vs 6±1 month (primary analysis window)
- Follow-up
- 6±1 month
Methodological detailsmultinational, medical chart review, early access programmes
- Multinational
- Medical chart review
- Early access programmes
Main finding
As reported in the abstract
6±1 month
- SLEDAI-2K, median (IQR), baseline (n=47)
- 6.0 (8.0)
- SLEDAI-2K, median (IQR), 6±1 month (n=40)
- 2.0 (4.0)
- Physician Global Assessment (PGA), median (IQR), baseline (n=39)
- 1.8 (1.0)
- PGA, median (IQR), 6±1 month (n=29)
- 0.3 (1.0)
- Definition of Remission in SLE (DORIS) remission, baseline
- 0/39
- DORIS remission, 6±1 month
- 9/29, 31.0%
- Lupus Low Disease Activity State (LLDAS), baseline
- 3/39, 7.7%
- LLDAS, 6±1 month
- 17/29, 58.6%
Observational data: associations, not effects.
Safety
| Outcome | Values |
|---|---|
| Withdrawal from anifrolumab | Anifrolumab 12.8% |
- Withdrawal from anifrolumab — Due to worsening symptoms
- 4 (8.5%)
- Withdrawal from anifrolumab — Due to improving symptoms
- 1 (2.1%)
- Withdrawal from anifrolumab — For other reasons
- 1 (2.1%)
Original publication
Real-world experience of anifrolumab treatment in patients with moderate-to-severe SLE: a retrospective study of patients in early access programmes. Lupus Sci Med. Published 15 April 2026. doi:10.
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