First placebo-controlled long-term trial of anifrolumab shows positive results in patients with lupus

Reviewed by Emily Henderson, B.Sc.Nov 14 2022

Type I interferon (IFN) is a powerful immune activator that is present at high levels in the majority of patients with lupus, an autoimmune disease. In Arthritis & Rheumatology, researchers report positive results from the first placebo-controlled long-term trial of anifrolumab-;a human monoclonal antibody that targets the type I IFN receptor-;in patients with lupus.

In the long-term extension trial of two earlier phase 3 trials, patients continued anifrolumab 300 mg, switched from anifrolumab 150 mg to 300 mg, or were re-randomized from placebo to either anifrolumab 300 mg or continued placebo, administered every 4 weeks, with all patients also receiving standard therapy. Anifrolumab was administered as an intravenous infusion.

Treatment with anifrolumab was well tolerated and had an acceptable long-term safety profile, while sustaining reduction in lupus disease activity and reducing or eliminating the need for steroid medications.

Managing systemic lupus erythematosus is challenging, due to the complexity of the disease itself, as well as from treatments like oral corticosteroids that can reduce disease activity, but also place a significant burden on patients when used in high doses long-term. These new data from the TULIP extension trial-;the longest placebo-controlled clinical trial performed in lupus to date-;support the benefit-risk profile of anifrolumab seen in previous trials, now over four years."

Hussein Al-Mossawi, MD, PhD, Corresponding Author, AstraZeneca