Biopharmaceutical company AstraZeneca plc (LSE: AZN) (STO: AZN) (Nasdaq: AZN) announced on Wednesday that its Phase III TULIP-SC trial of Saphnelo (anifrolumab) met its primary endpoint in patients with systemic lupus erythematosus (SLE).

An interim analysis showed that subcutaneous administration delivered a statistically significant and clinically meaningful reduction in disease activity compared to placebo.

The study enrolled 367 patients with moderately to severely active, autoantibody-positive SLE, all receiving standard therapy such as corticosteroids, antimalarials and immunosuppressants. The primary outcome was measured by the British Isles Lupus Assessment Group based Composite Lupus Assessment at week 52.

The safety profile was consistent with intravenous administration, which is already approved for moderate to severe SLE in more than 70 countries, including the US, EU and Japan. More than 38,000 patients worldwide have received Saphnelo to date.

Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, noted that the findings position Saphnelo as a potential self-administered treatment, aligning with patient preferences and clinical guidelines.

AstraZeneca continues to work with regulators to expand patient access to this formulation.