CHICAGO, Dec. 18, 2025 (GLOBE NEWSWIRE) -- The Foundation for Sarcoidosis Research (FSR) is proud to announce the release of its comprehensive Voice of the Patient report, capturing the powerful insights, lived experiences, and treatment priorities shared by hundreds of sarcoidosis patients and caregivers during the Externally-Led Patient-Focused Drug Development (EL-PFDD) meeting held with the U.S. Food and Drug Administration (FDA) on October 28, 2024.

This 50-page report contains extensive patient testimony, survey findings, and discussions from the five-hour virtual meeting, which convened nearly 350 patients, caregivers, clinicians, industry partners, and advocates. This critical resource elevates the voices of those living with sarcoidosis and outlines clear priorities for future research, clinical trial design, and therapeutic development.

Hosted by FSR President and CEO Mary McGowan and FSR Board Member and FSR Sarc Fighter Podcast host John Carlin, the EL-PFDD meeting provided a national platform for patients to share firsthand accounts of their symptoms, quality-of-life challenges, and experiences with current treatments. Participants engaged through live surveys, polling questions, panel discussions, patient and caregiver testimonials, written comments, and call-in sessions that shed light on the complex and far-reaching burden of sarcoidosis.

“The insights captured in this report are pertinent to advancing sarcoidosis research and drug development,” said Mary McGowan, President and CEO of FSR. “Patients have shared the challenges they face every day: delayed diagnosis, debilitating fatigue, chronic pain, and the heavy burden of long-term steroid use. Their voices must guide the next generation of therapies and clinical trials that truly reflect the lived experience of this disease.”

The report highlights several pressing issues raised by the sarcoidosis community:

• Limited and burdensome treatment options: Corticosteroids remain the most commonly used therapy, despite significant physical and emotional side effects. Many patients expressed the urgent need for safer, more effective therapies developed specifically for sarcoidosis.
• Major quality-of-life impacts: Fatigue emerged as the most debilitating symptom, often affecting patients’ ability to work, maintain relationships, and participate in daily activities. Chronic pain, breathing difficulties, and brain fog also significantly disrupt day-to-day life.
• Challenges in clinical trial design and access: Attendees emphasized the need for more inclusive and adaptive trial designs that reflect real-world sarcoidosis, including multi-organ involvement and diverse demographics. Participants also urged researchers to prioritize endpoints that align with patient-desired outcomes such as symptom stability, reduced fatigue, and relief from the burdens of long-term steroid use.
• Health equity and representation: The report underscores the importance of equitable diagnostic pathways, access to expert care, and representation in research, particularly for communities disproportionately affected by severe outcomes, including Black patients and veterans.

The Voice of the Patient report outlines a clear path forward for drug developers, researchers, clinicians, and regulators. Recommendations include:

• Improving diagnostic accuracy and identifying biomarkers
• Reducing reliance on long-term, high-dose steroids
• Expanding available therapies through new mechanisms targeting inflammation and symptoms
• Designing trials that reflect the complexity of multi-system disease
• Centering patient priorities in clinical endpoints and therapeutic development
  

“We are here not just to listen but to act,” said McGowan. “Together, we can transform the lives of those battling sarcoidosis.”

The full Voice of the Patient report is now available on FSR’s website. For more information, please visit stopsarcoidosis.org/pfdd.

About Sarcoidosis

Sarcoidosis (pronounced SAR-COY-DOE-SIS) is an inflammatory disease of unknown cause characterized by the formation of granulomas—tiny clumps of inflammatory cells—in one or more organs of the body. Sarcoidosis affects the lungs in approximately 90% of cases, but it can affect almost any organ in the body and in more advanced or chronic cases can impact multiple organs at the same time. Despite increasing advances in research, sarcoidosis remains difficult to diagnose with limited treatment options and no known cure.

About Foundation for Sarcoidosis Research

Established in 2000, the Foundation for Sarcoidosis Research (FSR), is the leading international non-profit organization dedicated to finding a cure for sarcoidosis and improving care for sarcoidosis patients through research, education, and support. Since inception, FSR has fostered nearly $10 million in sarcoidosis-specific research efforts and has worked diligently to provide resources to thousands. For more information and to join our community, visit www.stopsarcoidosis.org.

For more information or to schedule an interview, please reach out to:

Cathi Davis, FSR Communications and Marketing Director
312-341-0500, cathi@stopsarcoidosis.org