Global Experts Reach Agreement on Top Barriers to Drug Development for Lupus
A recent study summarizes key insights on top barriers to developing new treatments for lupus, building on prior efforts of the Addressing Lupus Pillars for Health Advancement (ALPHA) project.
Through the project, researchers conducted in-depth interviews and surveyed lupus experts across 20 countries. The heterogeneity, or diversity of lupus, and the lack of a universally agreed disease definition were identified as primary barriers to advancing treatment development. A total of 30 diseases were identified as lupus-related, emphasizing that the term ‘lupus’ refers to a disease cluster characterized by widely diverse clinical manifestations – which is difficult to define and therefore challenging to conduct clinical trials.
The lack of predictive biomarkers for patient selection for clinical trials, and challenges with trial design, including increasing ethnic diversity and representation, and endpoints were among the highest prioritized roadblocks for lupus drug development and personalized treatments. The study findings encourage drug development professionals to validate disease-specific measures and to identify if specific symptoms are caused by lupus. It also provides a methodology that investigators can apply to similarly diverse diseases where low consensus on diagnosis and treatment exists.
“These results are very meaningful to the field,” said Professor Eric Morand, MBBS(Hons), PhD, FRACP, of Monash University, Australia, member of the project’s Global Advisory Committee. “We have learned so much, so quickly, about how much more we need to learn to change outcomes for lupus patients, and results like these make it clear that patients and investigators are on the same page about what is needed next.” Professor Morand is the Principal Investigator on the TULIP 2 trial of Anifrolumab, which recently announced promising phase III results.
The Advancing Lupus Pillars for Health Advancement project brings together for the first time the international lupus community to look holistically at the comprehensive set of issues the lupus field faces. Led by the Lupus Foundation of America, Tufts University School of Medicine Center for the Study of Drug Development and a Global Advisory Committee of lupus experts, the project provides the first truly global perspective on the state of the science, treatment and care. Learn more about the ALPHA project.