What clinops professionals need to know
The TULIP-SC trial demonstrated that subcutaneous Saphnelo significantly reduced disease activity in patients with moderate to severe systemic lupus erythematosus, offering a more convenient self-administered option compared to intravenous dosing. Safety was consistent with prior trials, and interim data support regulatory review already underway. For clinical operations teams, the findings highlight the growing importance of designing trials that accommodate flexible administration routes while maintaining rigorous efficacy and safety evaluation, an approach that can ease patient burden and improve adherence in complex autoimmune studies.
AstraZeneca has shared positive results from a pre-specified interim analysis of the Phase III TULIP-SC clinical trial (NCT04877691) evaluating Saphnelo (anifrolumab) in patients with systemic lupus erythematosus (SLE). In the study, subcutaneous (SC) delivery of Saphnelo achieved a statistically significant and clinically meaningful reduction in disease activity compared to placebo.1
In a press release, Susan Manzi, MD, MPH, professor of medicine and chair of the Medicine Institute at Allegheny Health Network, professor of medicine at Drexel University College, Philadelphia, and principal investigator of the TULIP-SC trial, said: “Today’s results for subcutaneous anifrolumab reinforce the efficacy and safety of this therapy and provide the opportunity for this important biologic to reach a wider group of patients in a more flexible and convenient way. 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.”
Safety profile and regulatory status
The safety profile observed in this most recent analysis was consistent with the known profile of Saphnelo administered as an intravenous (IV) infusion. Data from this readout are already under regulatory review and AstraZeneca plans to present findings at the American College of Rheumatology (ACR) Convergence 2025 annual meeting in late-October.
TULIP-SC trial design
TULIP-SC is a multicenter, randomized, double-blind, placebo-controlled study evaluating SC Saphnelo in patients with moderately to severely active, autoantibody-positive SLE receiving standard therapy.
- Eligible patients were aged 18 to 70 years and were required to be on oral corticosteroids, antimalarials, immunosuppressants, or a combination.
- A total of 367 participants on background therapy were randomized 1:1 to receive either Saphnelo 120 mg or placebo once weekly by accessorized prefilled syringe.
- A planned interim analysis occurred after the first 220 participants completed 52 weeks.
- The study included a 52-week open-label extension for patients completing the double-blind phase.
In the press release, Sharon Barr, executive vice president, biopharmaceuticals R&D, AstraZeneca, added: “Today’s news takes us one step closer in making the clinically meaningful benefits of Saphnelo accessible for more patients with systemic lupus erythematosus. The TULIP-SC 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. With Saphnelo, we hope to establish remission as an achievable treatment goal for more patients and we are actively working with regulatory authorities to bring this new administration option to patients as soon as possible.”
Background on prior approvals and studies
Saphnelo was approved by the FDA in August 2021 for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy. The approval was based on findings from across the Saphnelo clinical development program, which included two Phase III TULIP studies (NCT02446912, NCT02446899) and the Phase II MUSE trial (NCT01438489).2
TULIP-1, TULIP-2, and MUSE were all randomized, double-blind, placebo-controlled trials. The pivotal Phase III TULIP program consisted of two studies:
- TULIP-1 enrolled 457 patients randomized 1:2:2 to intravenous Saphnelo 150 mg, Saphnelo 300 mg, or placebo every four weeks. The trial did not meet its primary endpoint based on the SLE Responder Index 4.
- TULIP-2 enrolled 362 patients randomized 1:1 to intravenous Saphnelo 300 mg or placebo every four weeks. The trial met its primary endpoint, showing superiority across multiple measures of disease activity using the BILAG-Based Composite Lupus Assessment.
Meanwhile, the MUSE trial randomized 305 adults to Saphnelo 300 mg, Saphnelo 1,000 mg, or placebo every four weeks for 48 weeks. Results showed improvements versus placebo across multiple efficacy endpoints.
References
1. Saphnelo self-administration TULIP-SC Phase III trial meets primary endpoint in patients with systemic lupus erythematosus based on an interim analysis. News release. AstraZeneca. September 17, 2025. Accessed September 18, 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/saphnelo-met-primary-endpoint-in-tulip-sc.html
2. Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus. News release. AstraZeneca. August 2, 2021. Accessed September 18, 2025. https://www.astrazeneca.com/media-centre/press-releases/2021/saphnelo-approved-in-the-us-for-sle.html#
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