Saphnelo’s TULIP-SC Phase 3 trial shows significant reductions in lupus disease activity with a convenient self-administered subcutaneous option, supporting steroid-sparing treatment.
Written By: Pharmacally Medical News Desk
AstraZeneca has reported full Phase 3 results from the TULIP-SC trial, which evaluated a subcutaneous (SC), self-administration option of Saphnelo (anifrolumab) for adults with systemic lupus erythematosus (SLE).
The full Phase 3 analysis shows that weekly subcutaneous Saphnelo produced a statistically significant and clinically meaningful reduction in overall SLE disease activity compared with placebo, while patients continued standard background therapy. The findings confirm results seen in the earlier interim analysis and are now published in Arthritis & Rheumatology.
The trial supports Saphnelo as a treatment that can be administered at home or with caregiver or healthcare professional support, offering a convenient alternative to the existing intravenous (IV) formulation. This is consistent with the recent EU approval of a once-weekly pre-filled pen for self-administration, granted based on the TULIP-SC data.
Saphnelo (anifrolumab) is a monoclonal antibody that blocks the type I interferon receptor, a pathway linked to immune overactivity and inflammation in systemic lupus erythematosus. By inhibiting this signalling, Saphnelo helps reduce disease activity in patients with active lupus.
TULIP-SC study
TULIP-SC was a Phase 3 trial (NCT04877691), randomized, double-blind, placebo-controlled trial in adults with moderately to severely active systemic lupus erythematosus who were receiving standard background therapy. Patients were assigned to receive either subcutaneous Saphnelo 120 mg once weekly or placebo for 52 weeks.
TULIP-SC met its primary endpoint. At Week 52, a higher proportion of patients receiving subcutaneous Saphnelo achieved a (British Isles Lupus Assessment Group–based Composite Lupus Assessment) BICLA response compared with placebo (56.2% vs 37.1%).
Key secondary endpoints also supported the benefit of treatment. Among responders, a greater proportion maintained oral corticosteroid doses of 7.5 mg per day or less between Weeks 40 and 52 (56.2% vs 34.0%). Sustained clinical response and other secondary measures also favored Saphnelo, and the overall safety profile was consistent with what has been observed with the IV formulation.
Investigators noted that the efficacy previously seen with intravenous Saphnelo can also be achieved with subcutaneous administration, providing more flexibility for patients, including the possibility of at-home use.
AstraZeneca highlighted that the data reinforce the role of type I interferon pathway inhibition and add to evidence supporting improved disease control with reduced steroid reliance over time.
Saphnelo IV is already approved in more than 70 countries, including the US, EU and Japan, for adults with moderate to severe SLE who have active disease despite standard therapy. More than 40,000 patients worldwide have been treated with the IV formulation.
Based on the TULIP-SC trial, the EU has approved a once-weekly 120 mg pre-filled pen for subcutaneous self-administration. The SC formulation is also under review in several other countries, including the US and Japan.
About SLE
Systemic lupus erythematosus is a chronic, autoimmune disease that can affect multiple organs, with an unpredictable course marked by flares and long-term complications. It affects more than 3.4 million people worldwide and is one of the leading causes of death among young women in the United States, with higher impact seen in Asian, Black and Hispanic populations.
Reference
Saphnelo self-administration TULIP-SC trial demonstrates statistically significant and clinically meaningful reduction in systemic lupus erythematosus disease activity, 06 January 2026, Saphnelo self-administration TULIP-SC trial demonstrates statistically significant and clinically meaningful reduction in systemic lupus erythematosus disease activity
Manzi, S. et al, Efficacy and Safety of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus: The Randomized, Phase 3, TULIP-SC Study. Arthritis & Rheumatology. https://doi.org/10.1002/art.70041
Saphnelo Gains EU Approval for At-Home Subcutaneous Self-Administration in Lupus, 18 December 2025, https://pharmacally.com/saphnelo-gains-eu-approval-for-at-home-subcutaneous-self-administration-in-lupus/
Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus (Tulip SC), ClinicalTrials.gov ID NCT04877691, https://clinicaltrials.gov/study/NCT04877691