ArticleInnovation (Cambridge (Mass.))2025
Firsekibart versus compound betamethasone in acute gout patients unsuitable for standard therapy: A randomized phase 3 trial.
Article in Innovation (Cambridge (Mass.)), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed.
- 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.Advances in therapy · 2026Trial
- Bioequivalence of Two Firsekibart Subcutaneous Formulations: A Randomized, Double-Blind, Single-Dose, Parallel-Group Study in Healthy Chinese Participants.Clinical pharmacology in drug development · 2026Trial
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Phase 1 Study of Firsekibart in Chinese Healthy Participants.Clinical pharmacology in drug development · 2026Trial
- Sustained remission in refractory Schnitzler syndrome presenting with prominent acropachy: from anakinra induction to firsekibart maintenance.Clinical rheumatology · 2026Article
- Population pharmacokinetics and exposure-response modelling of firsekibart (GenSci048) in patients with acute gout flare: Implications for fixed-dose optimization.British journal of clinical pharmacology · 2026Article
- Firsekibart in Complex and Refractory Gout Patients Unsuitable for Conventional Therapy: A Real-World Case Series.International journal of rheumatic diseases · 2026Article
- Clinical response to firsekibart in a 73-year-old patient with tophaceous gout complicated by prostate cancer and chronic kidney disease: a case report.Translational andrology and urology · 2026Article
- Acute gout attack in a peritoneal dialysis patient treated with Firsekibart: a case report.Open medicine (Warsaw, Poland) · 2026Article
- Efficacy and safety of Qing Zhu Granules for acute gouty arthritis with dampness-heat obstruction syndrome: study protocol for a phase 3, multicenter, randomized, double-blind, placebo-controlled trial.Frontiers in medicine · 2026Article
- Risk Management in First-in-Human Trials of Intravenous Drugs: Current Practices and Future Perspectives.Therapeutics and clinical risk management · 2026Review
- Firsekibart for the Treatment of Gout Complicated by Type 2 Diabetes Mellitus: A Real-World Case Series.Journal of inflammation research · 2026Article
- The interplay between NLRP3 inflammasome and metabolic signals in gouty arthritis.Frontiers in immunology · 2026Review
- Firsekibart for steroid withdrawal in glucocorticoid-dependent refractory gout: a case report.Frontiers in immunology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This phase 3 trial evaluated the efficacy and safety of Firsekibart, a novel, fully human anti-interleukin-1β monoclonal antibody, in patients with frequent acute gout flares unsuitable for standard therapy. Patients were randomized (1:1, stratified by baseline pain visual analog scale [VAS]) to the Firsekibart (200 mg) or compound betamethasone (CB; 7 mg) group. Co-primary endpoints included change in pain intensity in the target joint at 72 h (non-inferiority testing) and time to first new flare within 12 weeks (superiority testing). The non-inferiority margin was 10 mm. The full analysis set included 311 patients (Firsekibart:
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.