Trial reportAdvances in therapy2026
Efficacy and Safety of Firsekibart in Patients with Acute Gout Unsuitable for Standard Therapy: 48-Week Results from an Open-Label Extension of a Randomized Phase 3 Trial.
Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05983445 (Safety & Efficacy of Genakumab in Patients With Frequent Flares), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Safety & Efficacy of Genakumab in Patients With Frequent Flares
Who cites it
1 citing paper in PubMed.
- Bridging with a single glucocorticoid injection in psoriatic arthritis: Real-world evidence of short-term effectiveness, safety, and enhanced response in high-inflammatory burden patients.Therapeutic advances in musculoskeletal disease · 2026Article
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPatients with recurrent acute gout flares who are unable to use nonsteroidal anti-inflammatory drugs (NSAIDs) or colchicine have limited alternatives and remain at high risk of flare recurrence. Firsekibart is a fully human monoclonal antibody targeting interleukin-1βeta (IL-1β) The objective of this study is to evaluate the longer-term efficacy and safety of firsekibart through 48 weeks in patients with acute gout unsuitable for standard anti-inflammatory therapy.
methodsThis was a multicenter, randomized, double-blind, positive-controlled phase 3 study of firsekibart with compound betamethasone. Followed by a 24-week open-label extension (OLE), conducted at hospitals in China. The double-blind phase was conducted from Week 0 to Week 24, followed by an OLE through Week 48 and a 12-week safety follow-up period after the last dose. Adults with ≥ 2 acute gout flares in the past year and a contraindication, intolerance, or inadequate response to NSAIDs and/or colchicine were enrolled. Patients completing the double-blind phase entered the OLE, during which firsekibart was administered for acute gout flares as needed. Efficacy included proportion of patients experiencing ≥ 1 gout flare recurrence, number of flares per patient, and time to first recurrence through Week 48, as well as rescue medication use during the OLE. Exploratory outcomes included health-related quality of life and flare-related pain. Safety included adverse events (AEs), laboratory tests, and immunogenicity.
resultsOf 313 patients (double-blind phase), 300 entered the OLE. By week 48, gout flare recurrence occurred in 70 patients (44.9%) in the firsekibart group compared with 116 (74.8%) in the positive control group (difference - 29.97%; 95% CI - 40.228% to - 18.544%). Kaplan-Meier analysis showed that the median time to first recurrence was not reached with firsekibart versus 37 days with positive control, indicating a 70% [hazard ratio (HR) 0.30; 95% confidence interval (CI) 0.223, 0.408; stratified log rank P < 0.0001] lower recurrence risk. Firsekibart maintained efficacy through Week 48. Treatment-emergent adverse events were reported in 89.7% of patients in the firsekibart group and 89.1% in the positive control group, with no new safety signals identified during extended follow-up.
conclusionIn this open-label extension study, firsekibart demonstrated sustained efficacy in reducing gout flare recurrence through 48 weeks, with a consistent and favorable safety profile, and no new safety signals identified during extended follow-up.
trial registrationNCT05983445.
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