Anifrolumab, a type I interferon (IFN) receptor antagonist, has been approved by the US FDA for treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. It is the first new drug for lupus to be approved in more than a decade. Data from three trials, the TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) phase 3 trial, which included two randomized, double-blind, placebo-controlled studies, TULIP-1 and TULIP-2 and the MUSE trial formed the basis of this approval.

However, the FDA has cautioned that since anifrolumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, it is not recommended for these patients.

Increased type I interferon (IFN) signaling is associated with increased disease activity in patients with SLE. Anifrolumab is a fully human monoclonal antibody against subunit 1 of the type 1 interferon receptor.

Dose: 300 mg IV infusion over a 30-minute period every 4 weeks

Dosage forms: Injection: 300 mg/2 mL (150 mg/mL) in a single-dose vial.

Side effects: Nasopharyngitis, upper respiratory tract infection, bronchitis, herpes zoster, cough, infusion-related reactions (headache, nausea, vomiting, fatigue, dizziness)

Contraindication: Patients with a history of anaphylaxis with anifrolumab-fni.

Warnings and precautions: Initiating treatment during an active infection should be avoided. Treatment may be discontinued if patients develop a new infection during treatment. It is not recommended for use with other biologic therapies. Patients receiving anifrolumab should not be administered live or live-attenuated vaccines.

(Source: FDA approves anifrolumab (saphnelo) as first new lupus treatment in more than 10 years - Medscape - Aug 02, 2021 & US FDA)