The US Food and Drug Administration has approved anifrolumab (Saphnelo) for subcutaneous self-administration using a once-weekly autoinjector in adult patients with systemic lupus erythematosus receiving standard therapy, providing an alternative to intravenous administration.

The approval was supported by results from the Phase 3 TULIP-SC randomized, double-blind, placebo-controlled trial, which evaluated subcutaneous anifrolumab in patients with moderate to severe systemic lupus erythematosus. Treatment with anifrolumab was associated with a statistically significant reduction in disease activity compared with placebo while patients continued background therapy, including oral corticosteroids, antimalarials, or immunosuppressants. The safety findings were consistent with the established profile of intravenous anifrolumab.

Systemic lupus erythematosus is a chronic autoimmune condition characterized by immune-mediated damage to multiple organ systems, with clinical manifestations that include musculoskeletal, dermatologic, and systemic symptoms. The disease affects more than 3.4 million patients globally and is associated with increased mortality, particularly among young women in the US. Corticosteroids remain a component of standard management but are associated with adverse events and contribute to cumulative organ damage.

In TULIP-SC, 367 patients aged 18 to 70 years were randomized 1:1 to receive 120 mg of subcutaneous anifrolumab or placebo via pre-filled syringe. Anifrolumab treatment was associated with improvements across multiple clinical outcomes, including reductions in disease activity while tapering corticosteroid doses, earlier achievement of response based on the British Isles Lupus Assessment Group–based Composite Lupus Assessment, and a longer time to disease flare. Additionally, 29% of patients achieved remission as defined by the Definitions of Remission in Systemic Lupus Erythematosus criteria, and 40.1% reached low disease activity status as measured by the Low-Level Disease Activity Score. 

Anifrolumab is a monoclonal antibody that targets the type I interferon receptor, inhibiting signaling pathways implicated in lupus pathophysiology. Contemporary management strategies highlight achieving remission or low disease activity while minimizing corticosteroid exposure.

The autoinjector enables patients to self-administer treatment outside the clinic and provides an alternative to intravenous administration.

Source: AstraZeneca