This phase 3 trial evaluated the efficacy and safety of Firsekibart,a novel,fully human anti-interleukin-1βmonoclonal antibody,in patients with frequent acute gout flares unsuitable for standard therapy.Pa-tients wer...This phase 3 trial evaluated the efficacy and safety of Firsekibart,a novel,fully human anti-interleukin-1βmonoclonal antibody,in patients with frequent acute gout flares unsuitable for standard therapy.Pa-tients 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 inten-sity 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(Firseki-bart:N=156;CB:N=155).At 72 h,the least squares mean change in pain VAS scores from baseline was-57.09 mm(95%confidence in-terval[CI]:-60.08 to-54.10)for Firsekibart and-53.77 mm(95%CI:-56.77 to-50.77)for CB,with treatment difference of-3.32 mm(95%CI:-7.56 to 0.91),establishing non-inferiority.The median time to first new flare was not reached within 12 weeks in the Firsekibart group compared with 45.0 days(95%CI:28.00 to 63.00)in the CB group.Firsekibart significantly reduced the risk of new flare by 90%vs.CB(haz-ard ratio:0.10;95%CI:0.06 to 0.17;stratified log rank p<0.0001).Effi-cacy was consistent across subgroups.Treatment-emergent adverse events occurred in 71.2%of Firsekibart-treated patients and 69.9%of those receiving CB.In conclusion,Firsekibart is effective and well toler-ated for acute gout flares in patients unsuitable for standard therapy,demonstrating non-inferiority in rapid pain relief and significant superi-ority in preventing flare compared with CB.展开更多
基金supported by Changchun GeneScience Pharmaceutical Co.,Ltd.,Changchun,China.
文摘This phase 3 trial evaluated the efficacy and safety of Firsekibart,a novel,fully human anti-interleukin-1βmonoclonal antibody,in patients with frequent acute gout flares unsuitable for standard therapy.Pa-tients 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 inten-sity 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(Firseki-bart:N=156;CB:N=155).At 72 h,the least squares mean change in pain VAS scores from baseline was-57.09 mm(95%confidence in-terval[CI]:-60.08 to-54.10)for Firsekibart and-53.77 mm(95%CI:-56.77 to-50.77)for CB,with treatment difference of-3.32 mm(95%CI:-7.56 to 0.91),establishing non-inferiority.The median time to first new flare was not reached within 12 weeks in the Firsekibart group compared with 45.0 days(95%CI:28.00 to 63.00)in the CB group.Firsekibart significantly reduced the risk of new flare by 90%vs.CB(haz-ard ratio:0.10;95%CI:0.06 to 0.17;stratified log rank p<0.0001).Effi-cacy was consistent across subgroups.Treatment-emergent adverse events occurred in 71.2%of Firsekibart-treated patients and 69.9%of those receiving CB.In conclusion,Firsekibart is effective and well toler-ated for acute gout flares in patients unsuitable for standard therapy,demonstrating non-inferiority in rapid pain relief and significant superi-ority in preventing flare compared with CB.
