MADRID, Spain. June 13, 2019 – Results of the first clinical trial sponsored by the Lupus Research Alliance and conducted through its Lupus Clinical Investigators Network (LuCIN) were presented today at the European Congress of Rheumatology (EULAR) 2019. Entitled VAlidation in LUpus of an Electronic Patient Reported Outcomes Tool (VALUE), the study showed that a custom smartphone app effectively enabled lupus patients to report on their health-related quality of life, fatigue and other symptoms in real time rather than completing surveys during periodic visits to physicians’ offices.
The app was designed with input from people with lupus to capture Patient Reported Outcomes (PROs).
“Patient Reported Outcomes can provide important data about the impact of a disease on an individual patient and/or their response to medication,” noted principal investigator Peter Lipsky, MD, co-founder of AMPEL BioSolutions. “However, usually patients report their responses to treatment at a monthly visit and since it can be difficult to remember how they felt over several weeks, the information is not always accurate.”
The VALUE study showed that patients were well able to record their PROs using the mobile app daily and weekly. The frequency of the information reported with the app surpassed that collected when patients filled out standard paper forms at their monthly visits.
Researchers concluded that the app “affords the opportunity to acquire frequent and highly reliable information about the impact of disease and response to medication in individual patients with SLE.”
Pfizer Inc., the Lupus Research Alliance, AMPEL BioSolutions and Tata Consultancy Services Ltd. jointly developed the new mobile app, using the Apple ResearchKit platform and building on well-accepted research tools that have been validated in lupus. LRA hopes to utilize the electronic app in future drug trials to effectively report patient outcomes in real time.
“The burden of living with autoimmune and inflammatory diseases is often significant for patients because these diseases are so complex,” said Michael Vincent, Senior Vice President and Chief Scientific Officer of Pfizer’s Inflammation and Immunology Research Unit. “Our collaboration with the LRA, AMPEL, and Tata is helping us to quantify the many factors that affect patients in day-to-day life. These results complement our understanding of the complex biology of autoimmune diseases and may be key in helping us bring meaningful treatments to patients.”
The VALUE trial was carried out by investigators in the Lupus Clinical Investigators Network (LuCIN), a clinical trials network made up of many of the most prestigious medical research centers and experienced lupus physician-scientists throughout North America. Administered by the affiliate of the Lupus Research Alliance called Lupus Therapeutics, LuCIN provides a framework to quickly and cost-effectively test potential new therapies, as well as methods to diagnose and monitor response to treatment.
“We are very excited to see these results from the first clinical trial conducted through LuCIN,” commented Albert Roy, Executive Director of Lupus Therapeutics. “Using the immediacy of an electronic app promises to help patients more accurately report their symptoms and how they respond to treatment.”
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.
About the Lupus Research Alliance
The Lupus Research Alliance aims to transform treatment while advancing toward a cure by funding the most innovative lupus research in the world. The organization’s stringent peer review grant process fosters diverse scientific talent who are driving discovery toward better diagnostics, improved treatments and ultimately a cure for lupus. Because the Lupus Research Alliance’s Board of Directors fund all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.