Abstract
Anifrolumab is the only US Food and Drug Administration-approved therapy for patients with systemic lupus erythematosus (SLE) that directly targets type I interferons (IFNs). The phase I study in scleroderma and phase II study in SLE served as a foundation for the phase III programme that included the TULIP-1 and TULIP-2 SLE trials. We review the biology of IFNs and the scientific rationale for developing an inhibitor of the type I IFN pathway. The focus then turns to the specific trials that led to regulatory approvals.
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