ArticleRheumatology and therapy2025
Efficacy and Safety of Firsekibart Compared to Etoricoxib for Gout Flares: A Phase 2, Multicenter, Open-label, Active-controlled, Randomized Non-inferiority Trial.
Article in Rheumatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05936268 (A Randomized, Open Lable, Multi-center, Active Competitor Phase 2 Study for Evaluating Efficacy and Safety of Genakumab for Injection as First Line Therapy in Patients With Gout Flare), which is not on this map. Cited by 8 papers.
What it found
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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.
A Randomized, Open Lable, Multi-center, Active Competitor Phase 2 Study for Evaluating Efficacy and Safety of Genakumab for Injection as First Line Therapy in Patients With Gout Flare
Who cites it
8 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
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Firsekibart, an Anti-interleukin-1β Monoclonal Antibody, in Healthy Chinese Participants: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study.Advances in therapy · 2025Trial
- Real-world effectiveness and safety of firsekibart versus compound betamethasone in frequent gout flares: a multicenter retrospective study.Clinical rheumatology · 2026Article
- RepurposingACS omega · 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
- Firsekibart for steroid withdrawal in glucocorticoid-dependent refractory gout: a case report.Frontiers in immunology · 2026Article
- Firsekibart as a Prophylactic Treatment for Acute Gout Flare in Participants Initiating Urate-Lowering Therapy: A Phase 2, Randomized, Open-Label, Multicenter, Active-Controlled Trial.ACR open rheumatology · 2025Article
Corrections and comments
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionFirsekibart, an anti-interleukin (IL)-1β monoclonal antibody, has demonstrated more sustained control of gout flares compared with compound betamethasone in previous clinical studies. This study evaluated the efficacy and safety of firsekibart versus etoricoxib for the treatment of frequent gout flares.
methodsIn this phase 2, randomized, open-label, active-controlled, multicenter study (NCT05936268), adults with gout according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2015 criteria experiencing frequent flares (≥ 2 flares within 12 months pre-screening) were randomized (1:1) to receive either a single subcutaneous injection of firsekibart 200 mg, or once-daily oral etoricoxib 120 mg administered until pain remission or treatment intolerance for up to 8 days. The primary endpoint was change from baseline in target joint pain intensity (0-100 mm visual analogue scale [VAS]) 72 h post-treatment. Non-inferiority (margin: 10 mm) was assessed first; if achieved, superiority was subsequently evaluated. Safety was also evaluated.
resultsOverall, 123 patients received firsekibart (n = 61) or etoricoxib (n = 62). Firsekibart was non-inferior and superior to etoricoxib in change from baseline in target joint pain VAS scores at 72 h post-treatment (difference: - 10.91 mm; 95% confidence interval [CI]: - 18.11, - 3.72). Treatment-emergent adverse events (TEAEs) occurred in 77.0% (n = 47) and 51.6% (n = 32) of patients receiving firsekibart and etoricoxib, respectively. The most common TEAE in both groups was hypertriglyceridemia. No TEAEs led to treatment discontinuation or study withdrawal, and no treatment-related serious adverse events (AEs) or deaths were reported.
conclusionsCompared with etoricoxib, firsekibart provides superior target joint pain relief and is well-tolerated in patients with frequent gout flares.
trial registrationClinicalTrials.gov identifier: NCT05936268; date of registration: 7 July 2023.
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