◎ Investigational

Litifilimab (BIIB059)

1
Evidence entries
2
Clinical trials
Overview
Treatment Details
Mechanism of Action
An investigational monoclonal antibody targeting BDCA2, a receptor found specifically on plasmacytoid dendritic cells — the immune cells primarily responsible for producing type I interferon in SLE. By binding BDCA2, litifilimab suppresses interferon and other inflammatory mediator production at its cellular source, upstream of where anifrolumab acts. Being evaluated in two ongoing Phase 3 trials for SLE, with topline results anticipated by the end of 2026; already holds FDA Breakthrough Therapy Designation for cutaneous lupus (skin-limited disease).
Dosing Notes
Investigational; subcutaneous injection, doses studied at 450 mg in trials to date.
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
Moderate ConfidenceSupported by limited controlled studies or consistent case series
In the Phase 2 trial, litifilimab at 450 mg was associated with a greater decrease in swollen and tender joint counts than placebo over 24 weeks. Phase 3 TOPAZ-1 and TOPAZ-2 trials are evaluating efficacy and safety in a broader SLE population, with topline results anticipated by the end of 2026.
Verified Jul 2026
Peer Reviewed
Trial of Anti-BDCA2 Antibody Litifilimab for Systemic Lupus Erythematosus
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Clinical Trials
Linked Trials2 trials