TOPLINE:

A real-world cohort of patients with systemic lupus erythematosus (SLE) treated with anifrolumab showed rapid and sustained improvements in disease activity and blood markers and had reduced steroid doses without increased organ damage, with a favourable safety profile.

METHODOLOGY:

• Researchers conducted a retrospective cohort study across 54 Spanish hospitals to evaluate the real-world effectiveness and safety of anifrolumab in routine practice.
• They included 206 adult patients with SLE (mean age, 44.6 years; 88.8% women) and extracted electronic medical records from June 2021 through April 2025.
• All patients received 300 mg anifrolumab intravenously every 4 weeks alongside standard immunosuppressants and glucocorticoids. Two patients with active lupus nephritis started on loading doses of 900 mg, and eight patients received anifrolumab as monotherapy.
• Assessments included disease activity indices (SLE Disease Activity Index 2000 [SLEDAI-2K], SLE Disease Activity Score [SLE-DAS], and Physician Global Assessment [PGA]), serologic markers, Lupus Low Disease Activity State (LLDAS) and Definitions of Remission in SLE (DORIS) remission, organ damage, and corticosteroid dose.
• Adverse events and other outcomes were recorded over a mean follow-up duration of 7.5 months.

TAKEAWAY:

• Median SLEDAI-2K, SLE-DAS, and PGA scores decreased markedly within a month and remained low through 12 months, complement C3/C4 levels increased, and anti-double-stranded DNA antibody levels decreased (P < .05 for all). The index for organ damage remained stable.
• The achievement of LLDAS increased from 14.1% of patients at baseline to 38.6% at month 1, 50% at month 6, and 71.4% at month 12 (P < .01 for all), and DORIS remission increased from 0% at baseline to 17.5% at month 6 and 14.3% at month 12 (P < .05 for both).
• The mean daily prednisone dose decreased from 8.8 mg/d at baseline to 4.3 mg/d at 12 months (P < .0001).
• A total of 27 patients (13.1%) experienced adverse events — most commonly herpes zoster, headache, and upper respiratory tract infections. Serious infections occurred in eight patients (3.9%), and 20 patients (9.7%) discontinued treatment; drug retention was high early on.

IN PRACTICE:

"[The study] findings are consistent with pivotal clinical trials and previously published observational studies, reinforcing the external validity of trial data in routine clinical practice. Therefore, anifrolumab represents a valuable therapeutic option for patients with refractory or difficult-to-treat SLE," the authors of the study wrote.

SOURCE:

This study was led by Vanesa Calvo-Río, University of Cantabria, Santander, Spain. It was published online on March 19, 2026, in RMD Open.

LIMITATIONS:

The study was retrospective and lacked a control group. Most patients received concomitant immunosuppressants and glucocorticoids; thus, improvements could not be attributed to anifrolumab alone. The follow-up duration was variable and often short.

DISCLOSURES:

The authors did not declare receiving any specific funding for the study. Three authors reported receiving speaking and lecture fees and/or travel reimbursements from AstraZeneca and GSK.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.