International lupus community reaches first-ever agreement on treatment barriers

“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 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.”