ArticleRheumatology and therapy2026
Efficacy and Safety of Firsekibart in Treatment of Active Systemic Juvenile Idiopathic Arthritis: A Randomized Phase 2 Study.
Article in Rheumatology and 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 NCT05925452 (A Multicenter, Randomized Phase II/III Clinical Study to Evaluate the Efficacy and Safety of GenaKumab in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.), which is not on this map. Cited by 2 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.
A Multicenter, Randomized Phase II/III Clinical Study to Evaluate the Efficacy and Safety of GenaKumab in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.
Who cites it
2 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
- Sustained remission in refractory Schnitzler syndrome presenting with prominent acropachy: from anakinra induction to firsekibart maintenance.Clinical rheumatology · 2026Article
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20 authors.
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No grant is acknowledged in the PubMed record.
Abstract
introductionSystemic juvenile idiopathic arthritis (sJIA) is an autoinflammatory disorder that impacts children aged ≤ 16 years. This study evaluated the efficacy and safety of firsekibart, a fully human anti-IL-1β monoclonal antibody, in children with active sJIA.
methodsThis multicenter, randomized, open-label, active-controlled phase 2 study (NCT05925452) enrolled participants aged 2- < 18 years with active sJIA across 14 sites in China. Participants were randomized (1:1:1) to firsekibart 3.0 mg/kg or 4.0 mg/kg subcutaneously every 4 weeks, or tocilizumab intravenously every 2 weeks, for 24 weeks. The primary endpoint was modified JIA American College of Rheumatology Pediatric criteria (ACR Pedi) 30 response at day 28. Secondary endpoints included ACR Pedi 30/50/70/90 responses, corticosteroid tapering, immunogenicity, and safety.
resultsFifty participants were randomized (firsekibart 3.0 mg/kg: n = 17; 4.0 mg/kg: n = 16; tocilizumab: n = 17). At day 28, ACR Pedi 30 response rates were 94.1% (95% CI 71.3-99.9), 75.0% (47.6-92.7) and 82.4% (56.6-96.2) in the firsekibart 3.0 mg/kg, 4.0 mg/kg, and tocilizumab groups, respectively. Firsekibart 3.0 mg/kg achieved numerically higher ACR Pedi 70/90 responses. By the end of treatment, successful corticosteroid tapering occurred in 75.0%, 63.6%, and 62.5% of patients receiving firsekibart 3.0 mg/kg, 4.0 mg/kg, and tocilizumab, respectively. No MAS events or anti-drug or neutralizing antibodies were detected. Treatment-emergent adverse events (TEAEs) occurred in 70.6%, 93.8%, and 94.1% of participants in the firsekibart 3.0 mg/kg, 4.0 mg/kg, and tocilizumab groups, respectively. Grade ≥ 3 TEAEs were absent in the 3.0 mg/kg group. Common TEAEs mainly included infections and laboratory abnormalities.
conclusionsFirsekibart demonstrated rapid clinical improvement, steroid-sparing effects, and an acceptable safety profile. The 3.0 mg/kg dose provided the most favorable benefit-risk balance, with efficacy and safety outcomes comparable to tocilizumab, supporting further evaluation as a convenient once-every-4-weeks IL-1β-targeted option in future phase 3 trials.
trial registrationClinicalTrials.gov identifier, NCT05925452.
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