Standardized outcome measures may advance lupus drug development
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Simple, standardized outcome measures, including steroid-sparing, could advance lupus drug development, while clarifying the lupus spectrum may improve diagnosis time and patient understanding, according to a speaker at ACR Convergence.
“Long-standing barriers in lupus have impacted progress across lupus research and care, leading to significant diagnosis delays for patients, limited treatment options and poor access to care,” Karin Tse, MPH, senior research manager at the Lupus Foundation of America, told Healio Rheumatology. “The ALPHA Project has created a unique opportunity for global lupus experts across stakeholder groups to convene and not only identify and prioritize these barriers, but develop specific recommendations to address these issues.”
Tse and colleagues launched the Addressing Lupus Pillars for Health Advancement (ALPHA) Project to identify, prioritize and address top barriers in lupus affecting diagnosis, care, treatment and research. This effort included expert interviews and surveys to identify and prioritize barriers across drug development, clinical care and access to care among clinicians, researchers, biopharmaceutical and government representatives, patients and caregivers. Subsequently, to address these barriers, the 15-member ALPHA Global Advisory Committee convened an in-person stakeholder meeting in January 2020, which included a 2-round scoring survey.
In all, the meeting included 14 advisory committee members, two patients, an added clinician-researcher and staff from the Lupus Foundation of America and Tufts Center for the Study of Drug Development. Participants formed three breakout groups, with each including patient representation. Every group identified at least one actionable solution to achieve “success” per topic. Following a full group discussion, participants voted on one top solution per topic. Solutions were later assessed after the meeting based on feasibility, impact and implementation timeline.
According to Tse, simplifying and standardizing outcomes measures, such as steroid sparing, and defining the lupus spectrum ranked as the highest priority solutions — for drug development and clinical care, respectively — during the ALPHA Global Advisory Committee meeting. Meanwhile, leveraging social media — regarding access to care — received the highest score across all topics. Cross-cutting themes included using digital technology and applying specific considerations for pediatric populations, as drug development has been limited and outcomes may differ from adults, the researchers wrote.
“Community recommendations identified through the ALPHA Project have the potential to greatly advance lupus drug development, clinical care, and access to care, if implemented, and ultimately improve the quality of life for people with lupus,” Tse said. “For instance, simplifying and standardizing outcome measures in lupus clinical trials, including steroid-sparing, may be pivotal to advancing lupus drug development and increasing treatment options for people with lupus. Further clarifying the lupus ‘spectrum’ may improve time to diagnosis and aid both provider and patient understanding of the disease.”
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Tse K. Abstract 0436. Presented at: ACR Convergence 2020; November 5-9, 2020 (virtual meeting).
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