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News|Articles|April 27, 2026

FDA Clears Subcutaneous Anifrolumab Autoinjector for Moderate to Severe SLE

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Key Takeaways

  • FDA authorized once-weekly 120 mg subcutaneous anifrolumab autoinjector for adult moderate-to-severe SLE on standard therapy, offering an alternative to monthly IV administration without expanding labeled populations.
  • Phase 3 TULIP-SC randomized 367 patients to SC anifrolumab versus placebo; the primary BICLA endpoint at week 52 demonstrated statistically significant disease activity reduction.
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FDA approved a AstraZeneca's subcutaneous anifrolumab autoinjector for adults with moderate to severe systemic lupus erythematosus on standard therapy.

The FDA has approved a subcutaneous (SC) autoinjector formulation of anifrolumab-fnia (Saphnelo) for adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.1 The decision adds a self-administered option to the previously available intravenous (IV) formulation, without changing the drug’s indication or major use limitations.1

For clinicians, the main implication is practical. A home-based injection may improve access for patients who have difficulty attending infusion visits, while maintaining the same therapeutic role as IV anifrolumab.

Trial Evidence: TULIP-SC

Approval was based on the phase 3 TULIP-SC trial, a randomized, double-blind, placebo-controlled study in 367 adults aged 18 to 70 years with moderate to severe SLE on background standard therapy, including corticosteroids, antimalarials, or immunosuppressants.1,3

Participants were randomized 1:1 to receive weekly SC anifrolumab 120 mg or placebo. The primary endpoint was response on the British Isles Lupus Assessment Group–based Composite Lupus Assessment at week 52.1,3

According to AstraZeneca, SC anifrolumab significantly reduced disease activity compared with placebo. Additional findings included improvements in disease control with reduced corticosteroid use, earlier treatment response, and a delayed time to flare. In secondary and exploratory analyses, 29.0% of patients achieved DORIS remission and 40.1% reached a low disease activity state.1,3

However, detailed numerical results for the primary endpoint were not included in the announcement, and secondary outcomes should be interpreted cautiously.


Safety Profile

The safety profile of the SC formulation appears consistent with the established IV version. Current prescribing information highlights risks including serious infections (such as respiratory infections and herpes zoster), hypersensitivity reactions including anaphylaxis, and an uncertain effect on malignancy risk.1

Use with other biologic therapies is not recommended, and live or live-attenuated vaccines should be avoided during treatment. In IV trials, common adverse events included upper respiratory infections, bronchitis, infusion-related reactions, herpes zoster, and cough.1,4

Place in SLE Treatment

SLE management continues to focus on hydroxychloroquine, minimizing glucocorticoid exposure, and selective use of immunosuppressive and biologic therapies. Current guidelines emphasize treat-to-target strategies, aiming for remission or low disease activity while limiting long-term steroid toxicity.2

Anifrolumab targets the type I interferon receptor, blocking a pathway central

A home-based injection may improve access for patients who have difficulty attending infusion visits, while maintaining the same therapeutic role as IV anifrolumab.

to SLE pathogenesis.1,4 The IV formulation, approved in 2021, demonstrated efficacy in patients with active SLE despite standard therapy.4

The SC formulation carries the same limitation: efficacy has not been established in severe active lupus nephritis or central nervous system lupus.1


Clinical Considerations

The approval expands how anifrolumab can be given rather than introducing a new therapy. A self-administered option may reduce treatment burden and improve convenience, but its real-world impact on adherence, persistence, and patient outcomes remains unclear.

Interpretation of the data is also limited by the lack of detailed efficacy results in the announcement and the exploratory nature of some reported outcomes.1,3 Longer-term and comparative data—especially between weekly SC and monthly IV dosing—will be important in determining uptake in clinical practice.

Ongoing Development

Beyond the United States, SC anifrolumab has been approved in the European Union and Japan, with additional regulatory reviews ongoing. The drug is also being studied in other interferon-driven conditions, including cutaneous lupus, idiopathic inflammatory myopathies, systemic sclerosis, and lupus nephritis.1


References

  1. AstraZeneca. (2026, April 27). SAPHNELO approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus. BusinessWire. https://www.businesswire.com/news/home/20260427513110/en/SAPHNELO-approved-in-the-US-for-subcutaneous-self-administration-as-a-new-autoinjector-for-the-treatment-of-systemic-lupus-erythematosus
  2. Fanouriakis, A., Kostopoulou, M., Alunno, A., et al. (2024). EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Annals of the Rheumatic Diseases. https://pubmed.ncbi.nlm.nih.gov/37827694/
  3. Manzi, S., et al. (2025). Efficacy and safety of subcutaneous anifrolumab in systemic lupus erythematosus: The randomized, phase 3 TULIP-SC study. Arthritis & Rheumatology. https://doi.org/10.1002/art.70041
  4. Morand, E., Furie, R., Tanaka, Y., et al. (2020). Trial of anifrolumab in active systemic lupus erythematosus. New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMoa1912196

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