AstraZeneca’s Saphnelo Succeeds in Phase III as Self-Injectable Lupus Treatment

AstraZeneca's Saphnelo (anifrolumab) achieved the primary endpoint in the Phase III TULIP-SC trial for systemic lupus erythematosus (SLE), showing a statistically significant and clinically meaningful reduction of disease activity in autoantibody-positive, moderately to severely active SLE, when self-injected subcutaneously compared to placebo135.

The trial included patients already on standard therapy (oral corticosteroids, antimalarials, immunosuppressants), and disease activity was measured at 52 weeks using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA), requiring improvement across all affected organs at baseline without new flares135.

The safety profile of self-administered (subcutaneous) Saphnelo was consistent with the already approved intravenous (IV) formulation, with no new safety signals identified135.

Interim results are being reviewed by regulatory agencies and are slated for presentation at the American College of Rheumatology Convergence 20253.

Experts view self-injection as an important step for accessibility and patient convenience, as about half of SLE patients using biologics already use self-administration options35.

SLE affects over 3.4 million people worldwide and current standard care is often limited by ongoing dependence on corticosteroids, which are linked to significant long-term risks5.

Sources:

1. https://www.pharmanow.live/latest-news/saphnelo-sc-tulip-sle-results

3. https://www.clinicaltrialsarena.com/news/astrazeneca-saphnelo-sle/

5. https://www.indianpharmapost.com/diagnostic-center/lite/astrazenecas-saphnelo-succeeds-in-phase-iii-as-self-injectable-lupus-treatment-17835