Abstract: TH-PO1091
Efficacy and Safety of Firsekibart in Patients with Acute Gouty Arthritis with eGFR Less Than 60 mL/min per 1.73 m2: Post Hoc Analysis of 24-Week Data
Session Information
- CKD: Therapies, Innovations, and Insights
November 06, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Xue, Yu, Huashan Hospital Fudan University, Shanghai, China
- Chu, Tianshu, Henan Provincial People's Hospital, Zhengzhou, Henan, China
- Hu, Jiankang, Pingxiang People's Hospital, Pingxiang, Jiangxi, China
- Gou, Wei, Hebei Petro China Central Hospital, Langfang, China
- Zhang, Ning, Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
- Li, Juan, The First Affiliated Hospital of Hainan Medical University, Haikou, Hainan , China
- Yu, Jing, The FirstAffiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China
- Li, Rongping, The First Affiliated Hospital of GannanMedical University, Ganzhou, China
- Li, Rongbin, The First Hospital of Qiqihar, Qiqihar, China
- Qian, Long, The Second Hopital of Anhui Medical University, Hefei, China
- Duan, Xinwang, The Second Affiliated Hospital of Nanchang University, Nanchang, China
- Duan, Lihua, Jiangxi Provincial People's Hospital, Nanchang, Jiangxi, China
- Zou, Hejian, Huashan Hospital Fudan University, Shanghai, China
Background
About 70% gout patients have chronic kidney disease (CKD) stage ≥3 (estimated glomerular filtration rate (eGFR)<60ml/min/1.73m2),limiting treatment options like colchicine or NSAIDs due to renal toxicity concerns.Firsekibart,previously known as Genakumab,is a novel IgG4/λ anti-IL-1β monoclonal antibody.It is not excreted via kidney,making it a significant option for acute gout arthritis(GA) with CKD.Here,we report the clinical results of Firsekibart vs compound betamethasone(CB) in a subgroup of GA patients with eGFR<60.
Methods
This multicenter randomized double-blind double-dummy active-controlled phase III clinical trial was conducted in 51 centers(NCT05983445).GA patients aged 18-75,contraindicated, intolerant or refractory to NSAIDs and/or colchicine,with≥2 flares in prior year were randomized 1:1 to receive a single subcutaneous dose of Firsekibart (200 mg) or an intramuscular dose of CB 7 mg. Co-primary endpoints were change in pain intensity measured by VAS (0–100 mm) at 72h and the time to first new flare over 12 weeks.Secondary endpoints included percentage of patients with≥1 new flare and the safety evaluation.
Results
Of 313 patients, 42 had eGFR< 60 at baseline (21 in each group).95.24% patients had≥3 flares in the past year and 50% had gouty tophi.Firsekibart demonstrated a similar reduction in pain score(-58.22 (-67.52,-48.93) mm vs -58.33 (-67.64 -49.02) mm) (Least Squares Mean(95CI%)),delayed median time to first new episode(Not estimable vs 21 days) ,reduced the risk of a new flare by 98% over 12 weeks (HR 0.02; p=0.0002),by 96% over 24 weeks (HR 0.04,p＜0.0001).Fewer patients treated with Firsekibart experienced ≥ 1 new flare over 12 weeks (4.76% vs.95.24%) and 24 weeks (9.52% vs 95.00%).
Treatment emergent and treatment-related adverse events were 10 (47.6%) and 7 (33.3%) in Firsekibart group,versus 11 (52.4%) and 6 (28.6%) in CB group.No serious adverse events were reported in Firsekibart group.Neitiher Firsekibart nor CB showed significant damage to kidney function.
Conclusion
Compared with CB,Firsekibart showed a comparable effect in pain relief and offering significant better prevention of new flares in GA patients with eGFR <60.The safety profile in this sub population was consistent with that of overall study population.
Funding
- Commercial Support – Changchun GeneScience Pharmaceutical Co., Ltd.