Anifrolumab has recently been approved by the Therapeutic Goods Administration (TGA). It is indicated as an add-on to standard therapy for adult patients with moderate to severe active systemic lupus erythematosus (SLE). This chronic autoimmune disease produces inflammation, tissue damage, and pain. While SLE is complex and associated with many immunologic abnormalities, upregulation of type I interferon is thought to be a major pathogenic factor.

Anifrolumab is a monoclonal antibody that binds with high affinity and specificity to the type I interferon receptor (IFNAR1). Binding of anifrolumab to this receptor inhibits type I interferon signalling, thereby blocking its biological activity.

In the TULIP-2 trial, BICLA (British Isles Lupus Assessment Group–based Composite Lupus Assessment) response was used to measure improvement in disease activity. In the anifrolumab group, 47.8% had a BICLA response compared to 31.5% in the placebo group. Anifrolumab therapy was also associated with a reduction in glucocorticoid dose and greater improvement in the severity of skin disease compared to placebo.

Anifrolumab is administered as an intravenous infusion, typically every four weeks. Infusion-related reactions may occur involving headache, nausea, vomiting, fatigue, or dizziness. These reactions are typically mild or moderate in intensity. Anifrolumab also increases the risk of respiratory infections and herpes zoster. Therefore, caution is required in patients with chronic infection, a history of recurrent infection, or known risk factors for infection.

Anifrolumab is not currently subsidised on the Pharmaceutical Benefits Scheme (PBS). However, a submission is under consideration by the Pharmaceutical Benefits Advisory Committee.


  1. Morand EF, Furie R, Tanaka Y, Bruce IN, Askanase AD, Richez C, et al. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020; 382:211-21.
  2. Saphnelo® (Anifolumab) Australian approved product information. Macquarie Park: AstraZeneca. Approved March 2022.

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