Company: AZN
Filing Date: 2025-12-16
Form Type: 6-K
Source: 0001654954-25-013974
Chunk: 3

Company: ASTRAZENECA PLC
Filing Date: 2025-12-16
Form: 6-K
Chunk 3
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 of disease activity was measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52. 19 The BICLA requires improvement in all organs with disease activity at baseline with no new flares. 19

Participants (367) were randomised 1:1 to receive 120mg subcutaneous dose of anifrolumab or placebo administered via a pre-filled, single-use syringe. 19 A planned interim analysis was conducted when the first 220 participants reached week 52. 19 The trial also included an open-label extension period of 52 weeks for participants who completed the 52-week treatment period. 19

Saphnelo subcutaneous administration

Saphnelo will be available for subcutaneous self-administration via a once-weekly 120mg pre-filled pen. Since 2021, Saphnelo has been available in an IV infusion administered by healthcare professionals in a hospital or clinic setting. Subcutaneous administration offers patients the choice to self-administer treatment outside of the clinic and or with support from an HCP or caregiver via a simple process.

#### Saphnelo
Saphnelo (anifrolumab) is a first-in-class, fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of type I IFN. 15,20 Type I IFNs, such as IFN-alpha, IFN-beta and IFN-kappa, are cytokines involved in regulating the inflammatory pathways implicated in SLE. 21-26

Saphnelo IV is the first biologic with remission data in SLE from a four-year placebo-controlled Phase III trial (TULIP-LTE) and was measured with the DORIS criteria for remission. 27,28 DORIS is measured as clinical SLEDAI-2K, or "Systemic Lupus Erythematosus Disease Activity Index 2000" score of 0, physician global assessment <0.5, prednisolone/ equivalent dose of OCS dose of ≤5 mg per day and stable maintenance doses of immunosuppressants, including biologics. 29

Saphnelo continues to be evaluated in diseases where type I IFN plays a key role, including Phase III trials in cutaneous lupus erythematosus, myositis, systemic sclerosis and lupus nephritis.