|Target||Interferon α/β receptor|
|Other names||MEDI-546, anifrolumab-fnia|
|Drug class||Type I interferon receptor (IFN) antagonist|
|Main uses||Systemic lupus erythematosus (SLE)|
|Side effects||Upper respiratory infections, bronchitis|
|Typical dose||300 mg q 4 weeks|
|Chemical and physical data|
|Molar mass||145119.20 g·mol−1|
Anifrolumab, sold under the brand name Saphnelo, is a medication used to treat systemic lupus erythematosus (SLE). Specifically it is used for moderate to severe disease that is not controlled by usual treatments. It is given by injection into a vein.
The most common side effects are upper respiratory infections and bronchitis. Other side effects may include shingles. Safety in pregnancy is unclear. It is a monoclonal antibody that binds to type I interferon receptor, blocking the activity of type I interferons.
Anifrolumab was approved for medical use in the United States in 2021 and Europe in 2022. In the United States it costs about 5,000 USD per dose as of 2022. It is not commercially available in the United Kingdom as of 2022.
It decreases disease activity in about 47% of people compared to about 30% who improve without.
It is generally given at a dose of 300 mg given over 30 minutes every 4 weeks.
The most common side effect was shingles, which occurred in 5% of patients in the low-dose group, to 10% in the high-dose group, and to 2% in the placebo group. Overall adverse effect rates were comparable in all groups.
Mechanism of Action
In systemic lupus erythematous, the body can produce a great amount of type 1 interferon, which activates the immune system excessively and creates problems for lupus patients. Anifrolumab acts to block INF-1 from sending signals to other immune cells, which prevents the body from being attacked by itself.
Society and culture
On 16 December 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Saphnelo, intended for the treatment of moderate to severe systemic lupus erythematosus (SLE). The applicant for this medicinal product is AstraZeneca AB. Anifrolumab was approved for medical use in the European Union in February 2022.
Anifrolumab is the international nonproprietary name (INN).
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- Clinical trial number NCT01438489 for "A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus" at ClinicalTrials.gov
- Clinical trial number NCT02446912 for "Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus" at ClinicalTrials.gov
- Clinical trial number NCT02446899 for "Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus" at ClinicalTrials.gov