Efficacy and Safety of Anifrolumab in Systemic Lupus Erythematosus (SLE): A Systematic Review of PubMed Literature

Abstract: 

Systemic lupus erythematosus is a heterogeneous autoimmune disease characterized by loss of immune tolerance, widespread inflammation, and multiorgan damage. Despite advances in treatment, many patients remain restricted to standard therapies. Type I interferon signaling has been identified as a key factor leading to the development of more targeted therapy, including, Anifrolumab, which is a fully human monoclonal antibody that binds to type I interferon receptor subunit 1 (IFNAR1) and inhibits interferon signaling. To review clinical evidence on efficacy and safety of anifrolumab in adults with SLE, to evaluate whether targeting the type I interferon pathway represents an effective therapeutic approach. PubMed literature search was conducted to identify clinical studies evaluating the efficacy and safety of anifrolumab in adult patients with moderate-to-severe SLE, including randomized controlled trials, long-term extension studies, post-hoc analyses, translational studies, and Japanese sub-analyses. Across the reviewed clinical studies, anifrolumab consistently improved disease activity. Most trials reported higher response rates in anifrolumab-treated participants than in placebo-treated participants, particularly in global disease activity scores and skin-musculoskeletal manifestations, correlating with suppression of the type I IFN gene signature. Anifrolumab was generally well tolerated, with mostly mild to moderate adverse events. The most frequently reported side effects included upper respiratory tract infections, nasopharyngitis, bronchitis, and herpes zoster, with overall tolerability comparable to placebo. Anifrolumab (300 mg IV every 4 weeks) appears to be a well-tolerated, effective therapeutic option in the management of SLE, with a favourable safety profile and reduced incidence of serious adverse events compared with placebo.