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<article xsi:noNamespaceSchemaLocation="http://jats.nlm.nih.gov/publishing/1.1/xsd/JATS-journalpublishing1-mathml3.xsd" dtd-version="1.1" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"><front><journal-meta><journal-id journal-id-type="publisher-id">IJGPN</journal-id><journal-title-group><journal-title>International Journal of General Practice Nursing</journal-title></journal-title-group><issn>2981-9415</issn><eissn>2981-9423</eissn><publisher><publisher-name>Bio-Byword Scientific Publishing Pty. Ltd.</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.26689/ijgpn.v3i4.12641</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title>Firsekibart in Reducing High-Sensitivity C-reactive Protein Levels of Gout</title><url>https://artdesignp.com/journal/IJGPN/3/4/10.26689/ijgpn.v3i4.12641</url><author>XueYu,LiYi,LianYuling,GuFei,ChenChunxia,XuQian</author><pub-date pub-type="publication-year"><year>2025</year></pub-date><volume>3</volume><issue>4</issue><history><date date-type="pub"><published-time>2025-11-07</published-time></date></history><abstract>Background: Gout remains a challenging condition with rising global prevalence. The IL-1β drives disease pathogenesis, and high-sensitivity C-reactive protein (hsCRP) correlates with gout activity. Firsekibart, a novel fully human anti-IL-1β monoclonal antibody, has proven its efficacy on gout, while the data on reducing hsCRP remains limited. Methods: This multicenter, randomized, double-blind phase III trial compared Firsekibart (200 mg subcutaneous) with compound betamethasone (7 mg intramuscular) in acute gout patients who were contraindicated to, intolerant of, or unresponsive to NSAIDs and/or colchicine. Serum hsCRP levels were measured at 72 hours, 7 days post-dose, and 4 weeks post-dose. Results: Both groups achieved comparable hsCRP reduction at 72 hours (Firsekibart: −14.68 mg/L [95% CI: −15.75, −13.61] vs. compound betamethasone: −14.58 mg/L [−15.66, −13.50]; P=0.898). Firsekibart demonstrated better sustained suppression at 7 days post-dose (−18.63 vs. −9.28 mg/L, P&amp;lt;0.001) and 4 weeks (−18.37 vs. −12.65 mg/L, P&amp;lt;0.0001). Conclusion: Compared with compound betamethasone, Firsekibart showed a longer-lasting anti-inflammatory effect on gout patients. This result may provide significant clinical value in the management of gout and its associated complications.</abstract><keywords/></article-meta></front><body/><back><ref-list><ref id="B1" content-type="article"><label>1</label><element-citation publication-type="journal"><p>Punzi L, Scagnellato L, Galozzi P, et al., 2025, Gout: One Year in Review 2025. Clinical and Experimental Rheumatology, 43(5): 799–808.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B2" content-type="article"><label>2</label><element-citation publication-type="journal"><p>Asghari KM, Zahmatyar M, Seyedi F, et al., 2024, Gout: Global Epidemiology, Risk Factors, Comorbidities and Complications: A Narrative Review. BMC Musculoskeletal Disorders, 25(1): 1047.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B3" content-type="article"><label>3</label><element-citation publication-type="journal"><p>Yu W, Cheng JD, 2020, Uric Acid and Cardiovascular Disease: An Update from Molecular Mechanism to Clinical Perspective. Frontiers in pharmacology, 2020(11): 582680.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B4" content-type="article"><label>4</label><element-citation publication-type="journal"><p>Dehlin M, Jacobsson L, Roddy E, 2020, Global Epidemiology of Gout: Prevalence, Incidence, Treatment Patterns and Risk Factors. Nature Reviews: Rheumatology, 16(7): 380–390.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B5" content-type="article"><label>5</label><element-citation publication-type="journal"><p>Liu J, Liu G, Chu T, et al., 2025, The Progress of Immune Cells-induced Inflammatory Response in Gout. Current Pharmaceutical Design, advance online publication.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B6" content-type="article"><label>6</label><element-citation publication-type="journal"><p>Yang G, Kang HC, Cho YY, et al., 2022, Inflammasomes and their Roles in Arthritic Disease Pathogenesis. Frontiers in Molecular Biosciences, 2022(9): 1027917.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B7" content-type="article"><label>7</label><element-citation publication-type="journal"><p>Zhuang Y, Pan B, Zhang Y, et al., 2024, Structure-activity Relationships of Natural and Synthetic Lathyrane-based Diterpenoids for Suppression of NLRP3-driven Inflammation and Gouty Arthritis. Bioorganic Chemistry, 2024(150): 107558.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B8" content-type="article"><label>8</label><element-citation publication-type="journal"><p>Ridker PM, Hennekens CH, Buring JE, 2000, C-reactive Protein and other Markers of Inflammation in the Prediction of Cardiovascular Disease in Women. The New England Journal of Medicine, 342(12): 836–843.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B9" content-type="article"><label>9</label><element-citation publication-type="journal"><p>Meng J, Li Y, Yuan X, et al., 2017, Effects of febuxostat on Insulin Resistance and Expression of High-sensitivity C-reactive Protein in Patients with Primary Gout. Rheumatology international, 37(2): 299–303.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B10" content-type="article"><label>10</label><element-citation publication-type="journal"><p>Santas E, Villar S, Palau P, et al., 2024, High-sensitivity C-reactive Protein and Risk of Clinical Outcomes in Patients with Acute Heart Failure. Scientific Reports, 14(1): 21672.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B11" content-type="article"><label>11</label><element-citation publication-type="journal"><p>Tan H, Zhang S, Liao J, et al., 2024, Mechanism of Macrophages in Gout: Recent Progress and Perspective. Heliyon, 10(19): e38288.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B12" content-type="article"><label>12</label><element-citation publication-type="journal"><p>Ridker PM, Everett BM, Thuren T, et al., 2017, Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease. The New England Journal of Medicine, 377(12): 1119–1131.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B13" content-type="article"><label>13</label><element-citation publication-type="journal"><p>Terkeltaub RA, Schumacher HR, Carter JD, et al., 2013, Rilonacept in the Treatment of Acute Gouty Arthritis: A Randomized, Controlled Clinical Trial using Indomethacin as the Active Comparator. Arthritis Research &amp; Therapy, 15(1): R25.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B14" content-type="article"><label>14</label><element-citation publication-type="journal"><p>So A, De Smedt T, Revaz S, et al., 2007, A Pilot Study of IL-1 Inhibition by Anakinra in Acute Gout. Arthritis Research &amp; Therapy, 9(2): R28.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B15" content-type="article"><label>15</label><element-citation publication-type="journal"><p>Schlesinger N, Pillinger MH, Simon LS, et al., 2023, Interleukin-1β Inhibitors for the Management of Acute Gout Flares: A Systematic Literature Review. Arthritis Research &amp; Therapy, 25(1): 128.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B16" content-type="article"><label>16</label><element-citation publication-type="journal"><p>Schlesinger, N, Pillinger MH, Simon LS, et al., 2023, Interleukin-1β Inhibitors for the Management of Acute Gout Flares: A Systematic Literature Review. Arthritis Research &amp; Therapy, 25(1): 128.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B17" content-type="article"><label>17</label><element-citation publication-type="journal"><p>FitzGerald JD, Dalbeth N, Mikuls T, et al., 2020, 2020 American College of Rheumatology Guideline for the Management of Gout. Arthritis Care &amp; Research, 72(6): 744–760.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B18" content-type="article"><label>18</label><element-citation publication-type="journal"><p>Xue Y, Chu T, Hu J, et al., 2025, Firsekibart Versus Compound Betamethasone in Acute Gout Patients Unsuitable for Standard Therapy: A Randomized Phase 3 Trial. Innovation (Cambridge (Mass.)), 6(8): 101015.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B19" content-type="article"><label>19</label><element-citation publication-type="journal"><p>Guo Q, Jin Y, Chen X, et al., 2024, NF-κB in Biology and Targeted Therapy: New Insights and Translational Implications. Signal Transduction and Targeted Therapy, 9(1): 53.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B20" content-type="article"><label>20</label><element-citation publication-type="journal"><p>Tan H, Zhang S, Zhang Z, et al., 2024, Neutrophil Extracellular Traps Promote M1 Macrophage Polarization in Gouty Inflammation via Targeting Hexokinase-2. Free Radical Biology &amp; Medicine, 2024(224): 540–553.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B21" content-type="article"><label>21</label><element-citation publication-type="journal"><p>Gao F, Peng H, Gou R, et al., 2025, Exploring Neutrophil Extracellular Traps: Mechanisms of Immune Regulation and Future Therapeutic Potential. Experimental Hematology &amp; Oncology, 14(1): 80.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B22" content-type="article"><label>22</label><element-citation publication-type="journal"><p>Mitroulis I, Kambas K, Chrysanthopoulou A, et al., 2011, Neutrophil Extracellular Trap Formation is Associated with IL-1β and Autophagy-related Signaling in Gout. PloS One, 6(12): e29318.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B23" content-type="article"><label>23</label><element-citation publication-type="journal"><p>Wijdan SA, Nasir Abbas Bokhari SM, Alvares J, et al., 2025, The Role of Interleukin-1 Beta in Inflammation and the Potential of Immune-targeted Therapies. Pharmacological Research-Reports, 2025(3): 100027.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B24" content-type="article"><label>24</label><element-citation publication-type="journal"><p>de Koning HD, Schalkwijk J, van der Ven-Jongekrijg J, et al., 2013, Sustained Efficacy of the Monoclonal anti-interleukin-1 Beta Antibody Canakinumab in a 9-month Trial in Schnitzler’s Syndrome. Annals of the Rheumatic Diseases, 72(10): 1634–1638.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B25" content-type="article"><label>25</label><element-citation publication-type="journal"><p>Richette P, Doherty M, Pascual E, et al., 2017, 2016 Updated EULAR Evidence-based Recommendations for the Management of Gout. Annals of the Rheumatic Diseases, 76(1): 29–42.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B26" content-type="article"><label>26</label><element-citation publication-type="journal"><p>Schlesinger N, Alten RE, Bardin T, et al., 2012, Canakinumab for Acute Gouty Arthritis in Patients with Limited Treatment Options: Results from two Randomised, Multicentre, Active-controlled, Double-blind Trials and their Initial Extensions. Annals of the Rheumatic Diseases, 71(11): 1839–1848.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B27" content-type="article"><label>27</label><element-citation publication-type="journal"><p>Imazio M, Lazaros G, Gattorno M, et al., 2022, Anti-interleukin-1 Agents for Pericarditis: A Primer for Cardiologists. European Heart Journal, 43(31): 2946–2957.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B28" content-type="article"><label>28</label><element-citation publication-type="journal"><p>Schlesinger N, Mysler E, Lin HY, et al., 2011, Canakinumab Reduces the Risk of Acute Gouty Arthritis Flares during Initiation of Allopurinol Treatment: Results of a Double-blind, Randomised Study. Annals of the Rheumatic Diseases, 70(7): 1264–1271.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B29" content-type="article"><label>29</label><element-citation publication-type="journal"><p>Kong N, Xue Y, Mao L, et al., 2025, Efficacy and Safety of Firsekibart Compared to Etoricoxib for Gout Flares: A Phase 2, Multicenter, Open-label, Active-controlled, Randomized Non-inferiority Trial. Rheumatology and Therapy, advance online publication. https://doi.org/10.1007/s40744-025-00790-6</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B30" content-type="article"><label>30</label><element-citation publication-type="journal"><p>Li Y, Zhang Y, Lu J, et al., 2021, Anti-inflammatory Mechanisms and Research Progress of Colchicine in Atherosclerotic Therapy. Journal of Cellular and Molecular Medicine, 25(17): 8087–8094.</p><pub-id pub-id-type="doi"/></element-citation></ref><ref id="B31" content-type="article"><label>31</label><element-citation publication-type="journal"><p>Tan Q, Yang ZM, Chen W, et al., Trends and Development in Clinical Research of FDA-Approved Drugs Against Interleukin-1β: A Bibliometric Analysis. Preprint.</p><pub-id pub-id-type="doi"/></element-citation></ref></ref-list></back></article>
