TOPLINE:

Among patients with gouty arthritis initiating urate-lowering therapy, a single subcutaneous injection of firsekibart — an interleukin-1 beta antibody — reduced acute flares more than a daily dose of colchicine over 12 weeks and had a favorable safety profile.

METHODOLOGY:

• Researchers conducted a randomized, open-label, phase 2 trial at 41 Chinese centers and compared the efficacy of firsekibart with that of colchicine in preventing acute gout flares among adults initiating urate-lowering therapy.
• They included 162 adults with gouty arthritis between July 2023 and January 2024 who had two or more attacks of acute gout in the past year. All patients were male (mean age, 39.0-42.5 years).
• Patients were randomly assigned to receive a single subcutaneous injection of firsekibart 100 mg (n = 55) or 200 mg (n = 52), or oral colchicine 0.5 mg/d (n = 55) for 12 weeks.
• Urate-lowering therapy with allopurinol, febuxostat, or benzbromarone was initiated at baseline or within the week before screening and continued for 12 weeks; investigators adjusted doses and medications as needed.
• The primary endpoint was the mean number of acute gout flares per participant over 12 weeks. Secondary efficacy endpoints included the proportion of patients experiencing at least one flare over 12 weeks, and safety analysis included adverse events and immunogenicity.

TAKEAWAY:

• Over 12 weeks, the adjusted mean number of acute gout flares per participant was 0.02 with 100 mg firsekibart vs 0.34 with colchicine (rate ratio, 0.05; P = .0060). No flares occurred with 200 mg firsekibart.
• The proportion of patients experiencing at least one acute gout flare was lower by 20% with 100 mg firsekibart and by 21.8% with 200 mg firsekibart than with colchicine.
• The risk of having an acute gout flare was 93% lower with 100 mg firsekibart than with colchicine (hazard ratio, 0.07; P = .0127).
• Patients who received firsekibart had no treatment-emergent adverse events leading to discontinuation, no treatment-related serious adverse events, and no deaths. Antidrug antibodies were low titer and nonneutralizing and not associated with safety issues.

IN PRACTICE:

“The findings in this study suggest that firsekibart may serve as a novel strategy for preventing acute gout flares in patients initiating ULT [urate-lowering therapy], potentially transforming the management paradigm for gout,” the authors of the study wrote.

SOURCE:

This study was led by Yiyun Yu, MD, Huashan Hospital, Fudan University, Shanghai, China. It was published online on November 7, 2025, in ACR Open Rheumatology.

LIMITATIONS:

The 12-week follow-up prevented the assessment of long-term safety and sustained efficacy. All participants were Chinese men, thus restricting generalizability. The open-label design without blinding may have introduced bias.

DISCLOSURES:

This study received support from Changchun GeneScience Pharmaceuticals Co., Ltd. Two authors reported being affiliated with the funding agency.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.