Company: AZN
Filing Date: 2025-09-17
Form Type: 6-K
Source: 0001654954-25-010847
Chunk: 1

Company: ASTRAZENECA PLC
Filing Date: 2025-09-17
Form: 6-K
Chunk 1
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 analysis was consistent with the known clinical profile of Saphnelo administered as an intravenous (IV) infusion. 2-4

The TULIP-SC trial evaluated the efficacy and safety of the subcutaneous administration of Saphnelo compared to placebo in participants with moderately to severely active, autoantibody-positive SLE, with both treatment groups receiving standard therapy (oral corticosteroids, antimalarials, and/or immunosuppressants). 5

Affecting over 3.4 million people globally, SLE can impact any organ, leading many patients to experience debilitating symptoms, irreversible organ damage and poor health-related quality of life. 6-11 While oral corticosteroids are often used to provide relief from symptoms of SLE patients, they are associated with adverse events and short-term benefits without targeting the underlying drivers of the disease, preventing patients from experiencing adequate disease control and achieving remission. 12-14 Recent updates to clinical guidelines elevate the importance of treating to target remission or low disease activity and minimising the use of oral corticosteroids. 15,16

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."

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "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."

The reduction in disease activity in TULIP-SC was measured