Karen H. Costenbader
Disease heterogeneity and the lack of a clear disease definition are among the top barriers to advancing lupus care, according to survey data published in Lupus Science & Medicine.
“Research into the basic mechanisms of autoimmunity, and drug development and trials, are paying off in diseases as such as rheumatoid arthritis and psoriasis, with many new and effective medications coming on the market — and there is a sense that our time must be coming in lupus,” Karen H. Costenbader, MD, director of the Lupus Program at Brigham and Women’s Hospital, told Healio Rheumatology. “On the other hand, there is frustration that we are not there yet and growing recognition that there are still many barriers to having real breakthroughs for lupus care and improvement of outcomes.”
To identify barriers to drug development, and develop strategies to address those barriers, the Lupus Foundation of America, in collaboration with the Tufts University School of Medicine Center for the Study of Drug Development, founded the ALPHA Project. As part of its multiphase effort, 13 lupus experts, representing industry, academia and patients from the United States, Australia, Germany, South Korea and the United Kingdom, formed a Global Advisory Committee to guide the project.
Members of the committee conducted 17 in-depth expert interviews to characterize important barriers. The members then analyzed interview transcripts and used the information to develop a 23-question survey, which was distributed to an international group of 366 recipients, including clinicians, researchers, scientists and industry representatives. A total of 127 recipients from 20 countries responded to the survey.
Disease heterogeneity and the lack of a clear disease definition are among the top barriers to advancing lupus care, according to survey data.
According to survey results, the primary barriers to advancements in lupus care are disease heterogeneity and the lack of a clear disease definition, which subsequently impeded the development of clinically meaningful drug treatments, effective clinical care and patient access.
“Respondents also started to tackle the question of the definition of the lupus spectrum of related diseases, identifying 30 autoimmune conditions that may be lupus-related based on overlapping features, shared autoantibodies and pathophysiology,” Constenbader said in an interview.
Survey data also highlighted four subsequent barriers to improving outcomes in lupus, including: lack of diagnostic, predictive and prognostic biomarkers; flawed clinical trial designs; lack of access to clinicians familiar with lupus combined with limited awareness among nonexperts; lack of treatment adherence due to the patient socioeconomic status.
“Lupus is unique, with its own very complex biology and challenges that are different from those in other diseases and these need to be identified, understood, broken down and surmounted to get us where we should be — really improving diagnosis, treatment, quality of life, access to medications and treatments and survival for people with lupus,” Costenbader said. “With global alignment, we now can work to create a path forward to develop solutions.” – by Jason Laday
Disclosure: Costenbader reports consulting honoraria from AstraZeneca. Please see the full study for additional authors’ disclosures.