International lupus community reaches first-ever agreement on treatment barriers

July 31, 2019
Great optimism for the future with over 30 companies currently invested in new lupus therapies

Findings from a study published in Lupus Science & Medicine provide an actionable framework to advance the lupus field, which has seen many failed clinical trials, variations in care and poor access to care worldwide. The study, “Global Consensus Building and Prioritization of Fundamental Lupus Challenges: The ALPHA Project,” brought together experts across 20 countries to provide the first-ever global consensus on key issues in lupus that have been identified as major barriers in lupus diagnosis, care and treatment development.

“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,” said principal investigator Kenneth A. Getz, MBA, Center for the Study of Drug Development at Tufts University School of Medicine, in the statement.

Healthcare Purchasing News also reached out to Stevan W. Gibson, President and CEO of Lupus Foundation of America to get his take on why lupus has been so hard to treat and what this new study means for lupus patients.

“The Lupus Foundation of America had the vision for the ALPHA (Addressing Lupus Pillars for Health Advancement) Project based on years of conversation and information gathered from people with lupus, caregivers, the clinician-scientist community and industry.” Gibson explained. “We believe there are many strategies for addressing these barriers, including regulatory and advocacy approaches, communication efforts, scientific consensus building, among other approaches.”

 The study validated known challenges in lupus, identifying lupus heterogeneity as the primary barrier impeding drug development, clinical care and access. Additionally, experts agreed upon the five top barriers to improving outcomes in lupus:

 · Lack of diagnostic, predictive and prognostic biomarkers for lupus and lack of biomarkers to predict drug response in clinical trials;

· Flawed clinical trial design;

· Lack of access to clinicians familiar with lupus/limited awareness of lupus among non-expert medical professionals;

· Barriers to effective management of lupus due to social determinants of care in predominantly lower socioeconomic status areas; and

· lack of treatment adherence.

 “Many of the barriers identified in the ALPHA Project are related to clinical trial design,” Gibson told HPN. “Developing new treatments for lupus is incredibly complex, and there are many challenges that researchers face from how to measure outcomes to lack of diversity in clinical trial recruitment.”

Lupus also strikes mostly women, minorities and people from lower socioeconomic backgrounds – and limited access to doctors who are familiar with the condition makes matters worse.  

 “Lupus education and awareness is critical for providers at all stages of their career, including among medical fields beyond rheumatology,” Gibson continued. “On average, it takes nearly six years for people with lupus to be diagnosed from the time they first notice their lupus symptoms. We also know about two-thirds of people with lupus first discuss their symptoms with a primary care doctor. That is why the Lupus Foundation of America is partnering with organizations like the American Academy of Family Physicians, the Childhood Arthritis and Rheumatology Research Alliance and Rheumatology Nurses Society as part of our efforts to increase education and awareness of lupus.”

The ALPHA Project conducted interviews with and surveyed lupus thought leaders in research, clinical practice, biopharmaceutical industry, government and patient advocacy, through a collaborative effort led by the Lupus Foundation of America, researchers at the Center for the Study of Drug Development at Tufts University School of Medicine (Tufts CSDD) and a Global Advisory Committee of 13 lupus experts representing industry, academia and the patient voice.

The next step of the ALPHA Project will be to assemble the Global Advisory Committee and other lupus stakeholders to develop and implement a road map of specific solutions to address each barrier identified through this research.

“No one organization can tackle everything, which is why collaboration and agreement on a path forward is essential for the lupus community,” Gibson said. “While there is still much progress to be made, there is great optimism for the future with over 30 companies currently invested in new lupus therapies.”