TOPLINE:

The full results of a phase 3 clinical trial showed that patients with moderate-to-severe active systemic lupus erythematosus (SLE) who received standard treatment achieved greater reductions in disease activity and higher remission rates with 120 mg subcutaneous anifrolumab administered weekly for 52 weeks than those who received placebo.

METHODOLOGY:

• Researchers conducted a full analysis of a phase 3 trial to evaluate the efficacy and safety of subcutaneous anifrolumab in patients who had moderate-to-severe SLE disease activity despite receiving standard therapy.
• They included 367 patients (mean age, 42.5 years; 91.6% women) and randomly assigned them to receive either 120 mg subcutaneous anifrolumab (n = 184) or placebo (n = 183) once weekly for 52 weeks.
• Patients were required to be on a stable regimen of at least one standard therapy: oral glucocorticoids, an antimalarial, or an immunosuppressant.
• The primary endpoint was a reduction in disease activity as measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at week 52.
• A BICLA response required improvement in all affected organs with no new worsening, no increase in overall disease score, and no meaningful decline on the physician global assessment.

TAKEAWAY:

• At week 52, BICLA response rates were significantly higher in the anifrolumab group than in the placebo group (56.2% vs 37.1%; P = .0002).
• The proportion of BICLA responders maintaining reduced oral glucocorticoid doses from week 40 to week 52 was higher with anifrolumab than with placebo (56.2% vs 34.0%; P < .0001); the proportion of patients attaining a BICLA response sustained through week 52 was higher with anifrolumab vs placebo (41.5% vs 22.6%).
• At week 52, the rates of achievement of remission (29.0% vs 14.7%; P = .0012) and attainment of a low-disease-activity state (40.1% vs 26.0%; P = .0038) were significantly higher in the anifrolumab group than in the placebo group.
• Serious adverse events occurred in 11.9% of patients in the anifrolumab group vs 10.4% in the placebo group; discontinuations due to adverse events occurred in 7.6% vs 4.4% of patients, respectively.

IN PRACTICE:

“Weekly SC [subcutaneous] anifrolumab was well tolerated, and treatment benefits in clinically meaningful endpoints were demonstrated over placebo, consistent with those observed with monthly IV [intravenous] anifrolumab. The SC route of administration will provide an important alternative route of at-home administration and may increase treatment accessibility for patients with moderate-to-severe SLE,” the authors wrote. 

SOURCE:

This study was led by Susan Manzi, MD, MPH, Lupus Center of Excellence, Autoimmunity Institute, Allegheny Health Network, Pittsburgh, Pennsylvania. It was published online on December 29, 2025, in Arthritis and Rheumatology.

LIMITATIONS:

The study excluded patients with severe neuropsychiatric SLE or active lupus nephritis.

DISCLOSURES:

This study received funding from AstraZeneca, which manufactures anifrolumab. Some authors reported receiving grants, consulting fees, honoraria, research support, and travel support; holding patents and stock options; participating in leadership roles; or having other financial and nonfinancial ties with various pharmaceutical companies and organizations. Five authors declared being employees and shareholders of AstraZeneca.

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