✓ Standard of Care

Anifrolumab (Saphnelo)

1
Evidence entries
1
Clinical trials
1
High-confidence findings
Overview
Treatment Details
Mechanism of Action
A monoclonal antibody that binds the type I interferon receptor subunit 1 (IFNAR1), blocking signaling from all type I interferons at once. Since dysregulated type I interferon signaling is a central driver of SLE in many patients, this approach directly targets one of the disease's core amplification mechanisms rather than broadly suppressing the immune system. Approved by the FDA in 2021 as the second SLE-specific therapy after belimumab, and now administered to more than 40,000 patients worldwide.
Dosing Notes
Intravenous infusion, 300 mg every 4 weeks; a subcutaneous self-administered autoinjector formulation was approved in April 2026 for greater convenience.
Treatment Type
pharmaceutical
Clinical Evidence
What the Evidence Shows
Each finding below is linked to its primary source. Confidence levels reflect the quality and quantity of available evidence — not CelluTarget's endorsement of any treatment.
High: Supported by multiple robust studies or regulatory approval
Moderate: Supported by limited controlled studies or consistent case series
Low: Based on case reports, expert opinion, or early-phase data only
High ConfidenceSupported by multiple robust studies or regulatory approval
Anifrolumab IV infusion is approved for moderate-to-severe SLE in more than 70 countries, with more than 40,000 patients treated globally; a subcutaneous formulation was approved in the US in April 2026 for self-administration.
Verified Jul 2026
Institutional Research
Update on US Regulatory Review of Saphnelo Subcutaneous Administration in Systemic Lupus Erythematosus
Published February 2026
View source ↗
Clinical Trials
Linked Trials1 trial