Anifrolumab in systemic lupus erythematosus: a profile of its use

Anifrolumab (Saphnelo (TM)), an intravenously administered immunoglobulin G1 kappa monoclonal antibody targeting the type 1 interferon alpha receptor, is effective and generally well tolerated as an add-on to standard therapy in adults with moderate to severe systemic lupus erythematosus (SLE). Anifrolumab reduces overall disease activity in patients with moderate to severe SLE despite receiving stable standard-of-care treatment, based on the totality of evidence from randomized, double-blind, placebo-controlled, phase 2b and 3 clinical trials. Anifrolumab also has corticosteroid-sparing effects and reduces skin disease severity. Therapeutic benefits of anifrolumab appear to be sustained over longer-term treatment. With respect to tolerability, anifrolumab recipients are at increased risk of infections (including herpes zoster). Additional long-term data are being collected in an ongoing extension of the phase 3 trials. Plain Language Summary Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting multiple parts of the body, with common areas including the skin and joints. While the aetiology of SLE is complex and yet to be fully understood, dysregulation of the interferon (IFN) system is involved in disease development. Anifrolumab (Saphnelo T) is a monoclonal antibody that acts as an antagonist of the type 1 IFN receptor. In various countries worldwide, intravenous anifrolumab is approved as an add-on to standard therapy in patients with moderate to severe SLE. In these patients, add-on anifrolumab helps to reduce disease activity, the severity of skin disease and the need for oral corticosteroids. Adverse events are typically of mild to moderate intensity and are most commonly infections such as common colds. Anifrolumab is an effective and generally well-tolerated treatment option for adults with moderate to severe SLE despite standard therapy.