Real-world experience of anifrolumab treatment in patients with moderate-to-severe SLE: a retrospective study of patients in early access programmes.

Vital, E.M.; Chasset, F.; Faria, R.; Carter, L.M.; Kielar, D.; Chen, S.Y.; Chen, S.; Natman, J.; Waratani, M.

Real-world experience of anifrolumab treatment in patients with moderate-to-severe SLE: a retrospective study of patients in early access programmes.

All Authors

Vital, E.M.

Chasset, F.

Faria, R.

Carter, L.M.

Kielar, D.

Chen, S.Y.

Chen, S.

Natman, J.

Waratani, M.

LTHT Author

Vital, Edward

LTHT Department

NIHR Leeds Biomedical Research Centre
Rheumatology

Publication Date

2026

Item Type

Article

Abstract

Objective: The multinational ERYTHRO (NCT06046534) study investigated the experience of patients with moderate-to-severe SLE initiating anifrolumab treatment through routine clinical practice as part of two early access programmes. Method(s): Retrospective data were extracted from medical charts of adults with SLE who received intravenous anifrolumab 300 mg every 4 weeks alongside standard therapy during AMANA (NCT04750057) or the France Temporary Authorisation for Use (ATUc). The baseline period included >=6 months of data collection before anifrolumab initiation; follow-up data were collected for as long as data were available in the chart. Outcomes, including SLE Disease Activity Index-2000 (SLEDAI-2K), Physician Global Assessment (PGA) scores and rates of Definition of Remission in SLE (DORIS) and Lupus Low Disease Activity State (LLDAS) attainment, were assessed at baseline and at 6 months from the first anifrolumab dose. Outcome estimation at the 6-month follow-up time point was performed using data from two different windows (primary analysis: 6+/-1 month; sensitivity analysis: 6+/-2.5 months). Result(s): Of 47 enrolled patients who initiated anifrolumab, treatment was ongoing in 41 patients (87.2%) at the end of the ERYTHRO study; 6 patients (12.8%) withdrew from anifrolumab (4 (8.5%) due to worsening symptoms, 1 (2.1%) due to improving symptoms and 1 (2.1%) for other reasons). SLEDAI-2K and PGA scores (median (IQR)) decreased over 6 months of treatment (SLEDAI-2K, baseline: 6.0 (8.0), n=47; and 6+/-1 month: 2.0 (4.0), n=40; PGA, baseline: 1.8 (1.0), n=39; and 6+/-1 month: 0.3 (1.0), n=29). DORIS remission and LLDAS attainment rates increased from baseline over time (DORIS, baseline: 0/39; 6+/-1 month: 9/29, 31.0%; and LLDAS, baseline: 3/39, 7.7%; 6+/-1 month: 17/29, 58.6%). Conclusion(s): 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.