NEW YORK, Nov. 6, 2017 – Lupus Research Alliance welcomes compelling new data, presented at the American College of Rheumatology (ACR) annual meeting that demonstrated significant benefit for lupus patients treated with Stelara® (ustekinumab), a prescription medicine from the Janssen Pharmaceutical Companies. Stelara® is not approved for the treatment of lupus, but is approved by the FDA for certain autoimmune diseases. Through its drug repurposing program, the Lupus Research Alliance first identified Stelara® as a potential treatment for lupus and encouraged Janssen to pursue testing for this use.
Based on the positive results from the Phase 2 study, Janssen announced plans to test Stelara® in a future Phase 3 program. Phase 3 trials involve larger groups of patients and are necessary for the FDA to consider evaluating additional efficacy and safety data in order to consider potential approval of a drug as a treatment for a disease such as lupus.
“Lupus is a devastating autoimmune disease with symptoms that can range from debilitating fatigue to life-threatening organ damage,” noted Kenneth M. Farber, President and CEO of the Lupus Research Alliance. “These positive Phase 2 results and the initiation of Phase 3 development bring the hope of a new treatment closer to a community in urgent need of more options. The Lupus Research Alliance is particularly excited about the promise of Stelara®, having recognized its potential in lupus early on.”
In 2013 two of the Lupus Research Alliance legacy organizations, the Alliance for Lupus Research (ALR) and Lupus Research Institute (LRI), initiated an ongoing drug repurposing program to determine potential lupus treatments among drugs already approved by the FDA for other conditions. The ALR & LRI commissioned Drs. Peter Lipsky and Amrie Grammer of AMPEL BioSolutions LLC to carry out an in-depth analysis of all drugs & biologics approved for human use in the United States. After a comprehensive review of more than 150 therapeutics, AMPEL compiled a list of potential lupus treatments (LRxL™), in consultation with researchers and members of the lupus community, which was then vetted by an expert committee; Stelara® was the top-scoring biologic. Based on this work, the Lupus Research Alliance encouraged Janssen to test Stelara® in lupus, and the company subsequently opened a Phase 2 global trial in 2015.
“The availability of a new treatment with a favorable safety profile would represent an important and welcome advance for patients who have seen only one new treatment in over 50 years,” commented Mary Crow, MD, Co-Chair of the Lupus Research Alliance Scientific Advisory Board as well as Physician-in-Chief and Chair of the Department of Medicine at Hospital for Special Surgery and Chief of the Division of Rheumatology at HSS and NewYork-Presbyterian/Weill Cornell Medical Center. “Having advocated for Janssen to explore Stelara® in lupus, we are encouraged by these promising results and strongly support the company’s plans to further test Stelara® in Phase 3 studies.”