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

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

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 long-term placebo-controlled trial of anifrolumab—a human monoclonal antibody that targets the type I IFN receptor—in patients with lupus.

In the long-term extension study of two previous Phase 3 trials, patients continued to receive 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 sustainably reducing lupus disease activity and reducing or eliminating the need for steroid medications.

Treatment of systemic lupus erythematosus is challenging due to the complexity of the disease itself as well as treatments such as oral corticosteroids, which can reduce disease activity but also impose significant burden on patients when used long-term at high doses. These new data from the TULIP extension study – the longest placebo-controlled clinical trial conducted in lupus to date – support the benefit-risk profile of anifrolumab observed in previous studies now over four years.”

Hussein Al-Mossawi, MD, PhD, corresponding author, AstraZeneca

Source:

Wiley

Reference:

Kalunian, KC, et al. (2022) A phase III, randomized, placebo-controlled extension study of the long-term safety and tolerability of anifrolumab in active systemic lupus erythematosus. Arthritis & Rheumatology. doi.org/10.1002/art.42392.

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