New gout therapies show promise in phase 3 trials

At ACR Convergence 2025, the American College of Rheumatology’s annual meeting, researchers presented pivotal phase 3 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 3 trial (abstract 2130804): A multicentre, randomised, active-controlled phase 3 study evaluated Firsekibart (an anti-IL-1β monoclonal antibody) in patients with acute gouty arthritis who had limited treatment options. Results demonstrated both efficacy and safety, supporting 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) <60ml/min/1.73m². Across 24 weeks, the treatment maintained efficacy and a favourable 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 3 DISSOLVE studies revealed meaningful reductions in visible tophi among patients with uncontrolled gout treated with nanoencapsulated sirolimus with pegadricase (NASP), highlighting its potential in reducing long-term disease burden and improving physical function.

▶ NASP combination therapy (abstract 2128059): Also from the DISSOLVE trials, combination therapy of NASP 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.

Collectively, these studies reflect the advancement of alternative therapeutic strategies designed for gout patients with challenging comorbidities, treatment intolerance, or refractory disease, the ACR said.