October 16, 2024 —

As part of our researcher interview series, we are featuring 3 Questions with Patricia Katz, PhD, Professor of Medicine and Health Policy at the University of California, San Francisco. Dr. Katz chairs the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) Planning Committee on Patient Reported Outcomes (PRO) and is chairing a meeting on PROs for lupus October 16-17.

Lupus ABC is a public-private partnership with the U.S. Food and Drug Administration and other key lupus stakeholders with the mission to identify and pursue the most effective ways to accelerate lupus drug development.

The PRO Meeting brings together PRO experts and other key stakeholders including people living with lupus, to discuss the state of lupus PROs and establish a strategic roadmap for future working group efforts. PROs are crucial in understanding the patients’ perspective on how lupus affects their quality of life. The ultimate goal is to have PROs for lupus that have the regulatory acceptance to be used in clinical trials to assess how treatments affect symptoms, function and quality of life.

Dr. Katz answered our questions on what is meant by Patient Reported Outcomes, how these outcomes could impact clinical trials, and what she hopes the October meeting will achieve.

What are Patient Reported Outcomes?

Patient-reported outcomes (PROs) represent patients’ voices about their health or symptoms. Often, PROs measure symptoms that only the patient can evaluate, for example, pain or fatigue. PROs are not always consistent with physician measures of disease, which makes it especially important to consider them.

What potential impact can Lupus ABC make on the current state of PROs for lupus in the context of clinical trials?  

The Lupus ABC’s goal in this effort is to ensure that patients’ voices, through PROs, are incorporated into studies of new lupus medications and in the evaluation of clinical trial results.

What do you hope the PRO meeting will achieve? 

We hope that this week’s PRO meeting will identify the work needed for the FDA to recognize PROs in evaluating the results of clinical trials of medications.  Follow-up to the PRO meeting will develop specific plans of action to work toward the ultimate goal of PRO inclusion in clinical trials.

As the convener of Lupus ABC, the Lupus Research Alliance will keep you, our lupus community, updated about the progress of this project and others undertaken by the Consortium.