Anifrolumab shows long-term promise 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 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,” said corresponding author Hussein Al-Mossawi, MD, PhD, of AstraZeneca. “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.”

URL Upon Publication: https://onlinelibrary.wiley.com/doi/10.1002/art.42392

Additional Information

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Full Citation: “A Randomized, Placebo-controlled Phase 3 Extension Trial of the Long-term Safety & Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus.” Kenneth C. Kalunian, Richard Furie, Eric F. Morand, Ian N. Bruce, Susan Manzi, Yoshiya Tanaka, Kevin Winthrop, Ihor Hupka, Lijin (Jinny) Zhang, Shanti Werther, Gabriel Abreu, Micki Hultquist, Raj Tummala, Catharina Lindholm,and Hussein Al-Mossawi. Arthritis & Rheumatology; Published Online: November 12, 2022 (DOI: 10.1002/art.42392).

URL Upon Publication: https://onlinelibrary.wiley.com/doi/10.1002/art.42392

Author Contact: hussein.al-mossawi@astrazeneca.com

About the Journal

Arthritis & Rheumatology is an official journal of the American College of Rheumatology (ACR) and covers all aspects of inflammatory disease. The journal is published by Wiley on behalf of the ACR. For more information, please visit http://wileyonlinelibrary.com/journal/art.

About the American College of Rheumatology

The American College of Rheumatology (www.rheumatology.org) is the professional organization whose members share a dedication to healing, preventing disability, and curing the more than 100 types of arthritis and related disabling and sometimes fatal disorders of the joints, muscles, and bones. Members include practicing physicians, research scientists, nurses, physical and occupational therapists, psychologists, and social workers.

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