Experimental Lupus Rx Shows Promise

Anifrolumab lupus drug found to significantly cut disease activity in mid-stage trials

/ Author:  / Reviewed by: Beth Bolt, RPh

(RxWiki News) Lupus is a chronic and often disabling disease with very few treatment options. But there may be some hope on the horizon where that is concerned.

On Tuesday, biopharmaceutical company AstraZeneca presented new data on its experimental lupus drug, anifrolumab. The data demonstrated that anifrolumab reduced disease activity and improved lupus symptoms like rash and arthritis in a mid-stage clinical trial.

The US Food and Drug Administration (FDA) recently assigned anifrolumab "Fast Track" status, which expedites the development and review processes of drug candidates that treat serious conditions.

Only one other drug — GlaxoSmithKline's Benlysta — has been introduced in the past 60 years for the treatment of lupus.

"These positive results for anifrolumab represent real hope for patients with lupus, who have only seen one new treatment for their disease in almost 60 years," said Bing Yao, senior vice president of research and development at AstraZeneca, in a press release.

Lupus is a chronic autoimmune disease that can damage any part of the body, including the skin, joints and organs. Lupus occurs when the body's immune system attacks its own tissues.

No two cases of lupus are exactly alike. Symptoms may come on suddenly or slowly. They may be mild, severe, temporary or permanent. Most patients with lupus have a mild form of the disease marked by flare-ups (symptoms worsen) and remissions (symptoms improve).

Anifrolumab, which is given intravenously, is designed for patients with moderate to severe lupus. This drug works in a different way than Benlysta by targeting the type 1 interferon receptor (a protein involved in inflammation).

In the trial, 300 milligrams of anifrolumab produced a positive response in 34.4 percent of the patients studied after 169 days. This rate rose to 51.5 percent after one year. Anifrolumab also reduced the patients' need for oral corticosteroids (drugs used to reduce swelling).

“The lupus community has been disappointed too often with clinical trial results," said lead researcher Richard A. Furie, MD, head of the division of rheumatology at North Shore-LIJ Health System, in a press release. "We have been eagerly awaiting clinical data of this magnitude for many years."

According to the Lupus Foundation of America, at least 1.5 million people in the US and 5 million worldwide currently have a form of lupus.

This data was presented Nov. 10 at the American College of Rheumatology 2015 Annual Scientific Meeting. Research presented at conferences may not have been peer-reviewed.

Information on funding sources and conflicts of interest was not available at the time of publication.

Reviewed by: 
Review Date: 
November 11, 2015
Last Updated:
November 12, 2015