AstraZeneca announced positive interim results from the phase III TULIP-SC trial of Saphnelo (anifrolumab) in systemic lupus erythematosus (SLE).
- Subcutaneous (SC) dosing reduced disease activity versus placebo.
- Safety was consistent with intravenous (IV) administration.
- Patients remained on standard therapy: corticosteroids, antimalarials, and/or immunosuppressants.
Why It Matters for Patients
SLE affects more than 3.4 million people worldwide. It’s chronic, painful, and can damage multiple organs.
- Steroids provide short-term relief but drive long-term harm.
- Guidelines now stress remission or low disease activity as treatment goals.
- Flexible dosing matters: about half of biologic-treated lupus patients already use SC self-injections.
Expert Reactions
- Dr. Susan Manzi, TULIP-SC lead investigator: SC anifrolumab offers efficacy, safety, and convenience for patients.
- Sharon Barr, EVP R&D, AstraZeneca: SC Saphnelo could expand access, establish remission as a goal, and meet patient demand for self-administered options.
Inside the Trial
- Design: Phase III, randomized, double-blind, placebo-controlled.
- Participants: 367 patients, 18–70 years, with moderate to severe autoantibody-positive SLE.
- Intervention: Weekly 120 mg SC Saphnelo vs placebo.
- Primary endpoint: BICLA response at 52 weeks.
- Status: Interim readout on first 220 patients.
The Bigger Picture
- Saphnelo IV is already approved in 70+ countries.
- Over 38,000 patients have received it worldwide.
- AstraZeneca is expanding trials into cutaneous lupus, systemic sclerosis, myositis, and lupus nephritis.
Financial Notes
- AstraZeneca licensed Saphnelo from Medarex in 2004.
- Medarex’s co-promotion rights ended after its 2009 acquisition by BMS.
- Royalties: low to mid-teens, depending on geography.
What’s Next
- Full TULIP-SC data will be presented at ACR Convergence 2025, Boston.
- Regulatory reviews are ongoing.
- Open-label extension is underway for long-term evaluation.
