An international panel of experts on lupus has defined key issues that need to be overcome — with disease variability being the biggest challenge — to improve the clinical outcomes of patients living with the disease, as part of the Addressing Lupus Pillars for Health Advancement (ALPHA) project.
The key issues identified are discussed in the study, “Global consensus building and prioritization of fundamental lupus challenges: the ALPHA project,” published in Lupus Science & Medicine.
“Lupus is a complex, heterogeneous autoimmune disease that has yet to see significant progress towards more timely diagnosis, improved treatment options for short-term and long-term outcomes, and appropriate access to care,” the investigators said.
The ALPHA project is the first worldwide initiative to identify and develop strategies to tackle key barriers to the diagnosis, treatment, and care of patients living with lupus. The project is led by the Lupus Foundation of America (LFA), the Tufts Center for the Study of Drug Development (CSDD) at Tufts University School of Medicine, and a panel of lupus experts.
“This research effort is momentous for the international lupus community; one that has never before been brought together for an initiative to address the most critical issues facing the field,” Kenneth A. Getz, principal investigator at the CSDD, said in a news release.
“Establishing global consensus among lupus patients and professionals is an essential first step towards creating a clear and focused path forward for more timely and accurate diagnosis, greater access to care and improved treatment options for people living with lupus,” Getz added.
The ALPHA project’s Global Advisory Committee (GAC) — with 13 lupus experts representing industry, academia, and the lupus community — started by discussing and identifying critical points that needed to be addressed to improve the clinical outcomes of lupus patients. These points were then further refined through 17 interviews with lupus experts.
The LFA, CSDD, and GAC then created a online survey of 23 questions that was sent to international stakeholders in 20 countries worldwide to seek consensus. Of the 366 respondents with access to the online survey, 127 (35%) completed the entire survey.
The survey revealed that the high degree of disease variability was the main hindrance to lupus diagnosis and treatment advancement. Other main areas of concern were:
- Lack of biomarkers used in clinical trials and drug development.
- Flawed clinical trial design.
- Reduced patient access to physicians that specialize in lupus.
- Socioeconomic obstacles to effective disease management.
- Lack of treatment adherence.
“This is an exciting time for the international lupus community,” said Stevan W. Gibson, president and CEO of the LFA. “The Lupus Foundation of America is proud to lead this first-of-its-kind global project to begin tackling the crisis in the lupus field created by long-standing barriers. These study findings further support our commitment towards building consensus on the priorities in lupus across communities and continents, ultimately to develop solutions for those living with lupus around the world.”
The investigators said that next steps “will include organizing an international stakeholder meeting to develop a global road map of specific recommendations to address identified barriers, which may include multipronged strategies using regulatory and advocacy approaches, scientific consensus building, communication efforts, among other possible tactics.”