AstraZeneca’s Saphnelo Hits Key Milestone in Subcutaneous Lupus Trial

AstraZeneca’s Saphnelo Hits Key Milestone in Subcutaneous Lupus Trial

By, Admin 18 September 2025

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.

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