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New Gout Therapies Show Promise in Phase III Trials at ACR Convergence 2025

October 25, 2025 | ACR ConvergenceACR NewsTreatments

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CHICAGO – At ACR Convergence 2025, the American College of Rheumatology’s annual meeting, researchers presented pivotal Phase III studies highlighting novel therapeutic options for patients with gout, particularly those with limited treatment choices or uncontrolled disease. The findings underscore continuing progress in addressing a significant unmet need for safer, more effective therapies in this common and often debilitating condition.

Firsekibart in Acute Gouty Arthritis

  • Firsekibart Phase III Trial (Abstract 2130804): A multicenter, randomized, active-controlled Phase III study evaluated Firsekibart in patients with acute gouty arthritis who had limited treatment options. Results demonstrated both efficacy and safety, supporting Firsekibart as a potential new option for this underserved population.
  • Post-Hoc Analysis in Renal Impairment (Abstract 2131112): Investigators further explored Firsekibart in patients with estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m². Across 24 weeks, the treatment maintained efficacy and a favorable safety profile, suggesting clinical utility in patients with renal impairment who typically face restricted therapeutic options.

Novel Biologic Combinations for Uncontrolled Gout

  • Reduction in Tophi with NASP (Abstract 2127600): Data from the Phase III DISSOLVE studies revealed meaningful reductions in visible tophi among patients with uncontrolled gout treated with NASP, highlighting its potential in reducing long-term disease burden and improving physical function.
  • Nanoencapsulated Sirolimus Plus Pegadricase (Abstract 2128059): Also from the DISSOLVE trials, combination therapy of nanoencapsulated sirolimus with pegadricase demonstrated reductions in disease burden in uncontrolled gout. This approach leverages immune-modulating and urate-lowering strategies to address a patient population with historically few options.

Advancing Treatment for a Growing Patient Population
Collectively, these studies reflect a continued investment in gout research and the advancement of alternative therapeutic strategies designed for patients with challenging comorbidities, treatment intolerance, or refractory disease.

“Millions of people with gout struggle with inadequate treatment options, especially those living with kidney disease or uncontrolled disease despite standard therapy,” said [Insert ACR Spokesperson]. “The results presented at ACR Convergence this year highlight encouraging new approaches that could transform care for some of the most difficult-to-treat patients.”

 

Media Contact
Teri Arnold
Director, Public Relations & Communications
tarnold@rheumatology.org
757-272-7002

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About the American College of Rheumatology
Founded in 1934, the American College of Rheumatology (ACR) is a not-for-profit, professional association committed to advancing the specialty of rheumatology that serves over 10,000 physicians, health professionals, researchers and scientists worldwide. In doing so, the ACR offers education, research, advocacy and practice management support to help its members continue their innovative work and provide quality patient care. Rheumatology professionals are experts in the diagnosis, management and treatment of more than 100 different types of arthritis and rheumatic diseases.

About ACR Convergence
ACR Convergence, the annual meeting of the American College of Rheumatology, is where rheumatology meets to collaborate, celebrate, congregate, and learn. With hundreds of sessions and thousands of abstracts, it offers a superior combination of basic science, clinical science, business education and interactive discussions to improve patient care and advance the specialty. For more information about the meeting, visit the ACR Convergence page, or join the conversation on X by following the official hashtag (#ACR25).

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