Anifrolumab (Saphnelo) Wins FDA Approval for Subcutaneous Self-Administration in SLE

The US Food and Drug Administration (FDA) has approved anifrolumab-fnia (Saphnelo) for subcutaneous self-administration via a once-weekly 120 mg autoinjector, the Saphnelo Pen, for adult patients with moderate to severe systemic lupus erythematosus (SLE) receiving standard therapy.¹

According to AstraZeneca, the approval was based on results from the phase III TULIP-SC trial, published in Arthritis & Rheumatology in January 2026.² Anifrolumab had previously been available only as an intravenous infusion administered in clinical settings since its initial US approval in 2021.

"The approval of anifrolumab as a self-administered autoinjector is exciting news as it makes this important medicine more convenient and accessible for many more patients,” Susan Manzi, MD, MPH, chair of the Allegheny Health Network Medicine Institute, director of the Lupus Center of Excellence at the AHN Autoimmunity Institute, and principal investigator of TULIP-SC, said in a statement. “With its proven ability to significantly reduce disease activity and the risk of organ damage, anifrolumab has been a much-needed innovation in lupus."

The subcutaneous formulation addresses a practical barrier for patients requiring every-four-week IV infusions in clinic and aligns with recent ACR and EULAR guideline updates emphasizing treat-to-target strategies and corticosteroid minimization in SLE.¹

Anifrolumab remains the only approved type I interferon receptor antagonist in SLE, and AstraZeneca reports > 40,000 patients globally have received the drug to date.¹ Subcutaneous administration of anifrolumab has already been approved in the EU and Japan.¹

TULIP-SC Trial Design and Primary Efficacy Results

The TULIP-SC trial was a phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating subcutaneous anifrolumab versus placebo in adults aged 18 to 70 years with moderate to severe SLE on standard therapy, including oral corticosteroids, antimalarials, and/or immunosuppressants.¹ A total of 367 participants were randomly assigned in a 1:1 to receive anifrolumab 120 mg or placebo weekly via a pre-filled, single-use syringe.¹

The primary endpoint was British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at week 52, which requires improvement in all organ domains with active disease at baseline and no new flares.¹ According to AstraZeneca, subcutaneous anifrolumab achieved a statistically significant and clinically meaningful reduction in disease activity compared with placebo on this endpoint.¹ A planned interim analysis was conducted when the first 220 participants reached week 52 or withdrew from the study.¹

The press release did not disclose exact BICLA response rates, effect sizes, or p-values for the primary endpoint. Full trial data were published by Manzi et al in Arthritis & Rheumatology.²

Anifrolumab Subcutaneous Safety Profile and Secondary Endpoints in TULIP-SC

Across pre-specified secondary and exploratory endpoints, anifrolumab demonstrated clinically meaningful effects on multiple outcome measures, according to AstraZeneca.¹ The drug reduced SLE disease activity while enabling corticosteroid tapering to low doses (≤7.5 mg/day prednisone equivalent), and more patients receiving anifrolumab achieved BICLA response sooner compared with placebo.¹ Time to first flare was numerically delayed in the anifrolumab arm.¹

Among patients receiving anifrolumab, 29.0% achieved DORIS remission and 40.1% attained low-level disease activity as measured by the Lupus Low Disease Activity State (LLDAS) score on pre-specified secondary and exploratory endpoints.¹ The DORIS remission criteria include a clinical SLEDAI-2K score of 0, physician global assessment below 0.5, and prednisone-equivalent dose of 5 mg/day or less on stable immunosuppressant doses.¹

The safety profile observed with subcutaneous anifrolumab was consistent with the known clinical profile of the IV formulation, per the company.¹ The most common adverse reactions (≥5% incidence) with anifrolumab include nasopharyngitis, upper respiratory tract infections, bronchitis, infusion-related reactions, herpes zoster, and cough.¹ Serious infections, hypersensitivity reactions including anaphylaxis, and herpes zoster remain adverse events of special interest; the label notes increased malignancy risk with immunosuppressants and recommends avoiding live vaccines.¹

Anifrolumab continues to be evaluated in phase 3 trials across 4 additional type I interferon-driven indications, including cutaneous lupus erythematosus (LAVENDER), idiopathic inflammatory myopathies (JASMINE), systemic sclerosis (DAISY), and lupus nephritis (IRIS).¹ The IV formulation remains the first biologic with 4-year placebo-controlled remission data in SLE from the TULIP-LTE trial.¹

References

1. AstraZeneca. SAPHNELO approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus. Published April 27, 2026. Accessed April 27, 2026. 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. Manzi S, Furie R, et al. Efficacy and safety of subcutaneous anifrolumab in systemic lupus erythematosus: the randomized, phase 3, TULIP-SC study. Arthritis Rheumatol. 2025. doi:10.1002/art.70041

3. Morand E, Furie R, Tanaka Y, et al. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020;382(3):211-221.