Potential New Lupus Treatment Effectively Reduced Disease Activity in Trial

The Lupus Research Alliance has announced a potential new medicine for lupus, anifrolumab, reduced disease activity versus placebo in a second Phase III study. Anifrolumab is a therapeutic antibody that blocks type I interferons, a molecule that promotes lupus inflammation. Over 15 studies funded by the Lupus Research Alliance over the past decade into the role of type I interferons were pivotal to the eventual development of anifrolumab.

Called TULIP 2, the one-year pivotal trial measured disease activity using a well-established evaluation tool called the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA). To meet the primary endpoint defined as a statistically significant and meaningful reduction in disease activity, BICLA requires improvement in organs affected by lupus with no new flares.

A Phase III trial presents the data the U.S. Food and Drug Administration uses to decide whether or not to approve a new medicine.

TULIP 2 tested anifrolumab at a dose of 300 mg while the TULIP 1 tested anifrolumab at both 150 and 300 mg doses.

"It is tremendously gratifying to learn of this important success," said Dr. Mary Crow, Co-chair of the Lupus Research Alliance Scientific Advisory Board (SAB) and Physician-in-Chief/Chair of Department of Medicine at Hospital for Special Surgery and Chief of Rheumatology at HSS and NewYork-Presbyterian/Weill Cornell Medical Center. "The Lupus Research Alliance has made significant investments in research focused on the role of type I interferons in lupus, and I am personally very excited given my own research in this area."

"These positive results from a pivotal Phase III trial are very hopeful for people with lupus who have waited years for desperately needed new treatment options," Lupus Research Alliance President and CEO Kenneth M. Farber said. "We look forward to seeing the full results of the study and further progress in evaluating anifrolumab as a potential therapy."

The principal investigator of the study, Professor Eric F. Morand, Monash University, Australia is a past winner of the Lupus Research Alliance Distinguished Innovator Award which provides scientists with support to conduct novel research into the fundamental causes of systemic lupus erythematosus.

Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90% of people with lupus are women; lupus most often strikes during the childbearing years of 15-45. African Americans, Latinx, Asians and Native Americans are two to three times at greater risk than Caucasians. In lupus, the immune system, which is designed to protect against infection, creates antibodies that can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin, and joints.

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