Why Patient Perspectives Are Crucial in Lupus Trials, With Hoang Nguyen, Ph.D.

At this year’s American College of Rheumatology meeting, researchers from the Lupus Research Alliance (LRA) are presenting new insights from the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) — a partnership designed to make sure that people living with lupus play a central role in shaping future treatments.

Hoang Nguyen, Ph.D., assistant vice president of research at the LRA, explained that lupus is an incredibly complex and variable disease. Because it can affect different organs and cause different symptoms from person to person, it’s often hard to measure how well new treatments work. That’s why the Lupus ABC was created — to bring together patients, researchers, pharmaceutical companies, regulators and clinicians to tackle these challenges together.

A major focus of Lupus ABC is improving the use of patient-reported outcomes (PROs) in clinical trials. PROs capture how patients feel and function, including fatigue, pain and brain fog, rather than relying only on clinical measures such as kidney function or inflammation levels. While doctors tend to focus on organ involvement, patients often care most about how lupus impacts their daily lives.

Nguyen emphasized that including PROs can help ensure that new treatments improve symptoms that matter most to patients. The U.S. Food and Drug Administration has also shown strong interest in incorporating these patient-centered measures into how new lupus drugs are evaluated and approved.

Last October, the first Lupus ABC public meeting brought together all stakeholders — including patients — to discuss how to better integrate PROs into lupus trials. Participants agreed that pain, fatigue and cognitive symptoms (such as brain fog) should be top priorities for measurement. They also called for researchers to share study results with participants. Importantly, they recommended that PROs be included earlier in trial design — not as an afterthought — and that patients help identify which symptoms should be tracked.

Ultimately, Nguyen said she’s optimistic: “There’s a wider recognition of the value of including the voices of people with lupus in the drug development process. Lupus ABC reflects this desire of the community to bring their voices to the forefront.”