AstraZeneca's Saphnelo succeeds in Phase III as self-injectable lupus treatment

AstraZeneca reported positive Phase III results Wednesday for a subcutaneous formulation of Saphnelo (anifrolumab), saying the treatment significantly cut disease activity in patients with systemic lupus erythematosus (SLE) and matched the safety seen with the currently approved intravenous version. Findings from an interim analysis of the TULIP-SC study will be presented next month at the American College of Rheumatology's (ACR) annual meeting.

The TULIP-SC trial evaluated subcutaneous administration of Saphnelo against placebo in 367 patients with moderate-to-severe, autoantibody-positive SLE who were receiving standard background therapy consisting of oral corticosteroids, antimalarials, and/or immunosuppressants. The drug was administered once weekly via an accessorised prefilled syringe.

Disease activity was measured using the British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA), which requires sustained improvement across all affected organs with no new flares. The interim analysis, based on data from the first 220 participants who reached week 52, showed a statistically significant and clinically meaningful benefit over placebo, according to AstraZeneca.

Under regulatory review

"Despite guidelines recommending earlier intervention and biologic treatments, too many people with systemic lupus erythematosus rely on oral corticosteroids, which contribute to irreversible organ damage," commented Susan Manzi, principal investigator for the study. "Today's results… provide the opportunity for this important biologic to reach a wider group of patients in a more flexible and convenient way."

AstraZeneca said the TULIP-SC data are now under regulatory review. Sharon Barr, head of BioPharmaceuticals R&D at AstraZeneca, said the results "are especially important because approximately half of systemic lupus erythematosus patients today taking a biologic are already treated with a self-administered subcutaneous option."

Saphnelo was originally cleared in 2021 for administration by IV infusion in adults with moderate-to-severe SLE receiving standard therapy. If approved, the subcutaneous form would compete more directly with GSK's Benlysta (belimumab), which gained separate US and European nods in 2017 for its self-injectable version based on the BLISS-SC study, where 60.8% of patients achieved a response on the SLE Responder Index (SRI) after 52 weeks, versus 48.5% on placebo.

https://firstwordpharma.com/story/6093230