[Quality of life improvement with stapokibart in chronic rhinosinusitis with nasal polyps: a post hoc analysis of phase 3 CROWNS-2 study].

Abstract

<b>Objective:</b>Chronic rhinosinusitis with nasal polyps &#xff08;CRSwNP&#xff09; is a disease characterized by chronic inflammation of the nasal and paranasal sinus mucosa. Patients commonly experience symptoms such as nasal congestion, loss of smell, rhinorrhea, and facial pain or pressure, which significantly impair patients' quality of life. Stapokibart is an anti-interleukin-4 receptor &#x3b1; &#xff08;IL-4R&#x3b1;&#xff09; monoclonal antibody. This study aimed to assess the efficacy of stapokibart on improving patients' quality of life. <b>Methods:</b>In the phase 3 CROWNS-2 study, patients were randomized 1&#xfe30;1 to receive stapokibart or placebo once every 2 weeks for 24 weeks. Both groups then received stapokibart for 28 weeks, followed by an 8-week safety follow-up period. This post-hoc analysis of the CROWNS-2 study assessed the effects of stapokibart on 22-item sinonasal outcome test &#xff08;SNOT-22&#xff09; domain scores. <b>Results:</b>During the double-blind period, stapokibart significantly improved multiple SNOT-22 domain scores, including the Nasal, Ear/facial, Sleep, and Emotion domains, compared with placebo. These improvements were maintained and further progressed during the open-label extension and subsequent safety follow-up periods. <b>Conclusion:</b>Stapokibart provides significant clinical benefits across multiple dimensions of quality of life, offering important clinical evidence for the long-term management of CRSwNP. <b>&#x76ee;&#x7684;&#xff1a;</b>&#x6162;&#x6027;&#x9f3b;&#x7aa6;&#x708e;&#x4f34;&#x9f3b;&#x606f;&#x8089;&#xff08;chronic rhinosinusitis with nasal polyps&#xff0c;CRSwNP&#xff09;&#x662f;&#x4e00;&#x79cd;&#x4ee5;&#x9f3b;&#x8154;&#x53ca;&#x9f3b;&#x7aa6;&#x9ecf;&#x819c;&#x6162;&#x6027;&#x708e;&#x75c7;&#x4e3a;&#x4e3b;&#x8981;&#x7279;&#x5f81;&#x7684;&#x75be;&#x75c5;&#xff0c;&#x60a3;&#x8005;&#x5e38;&#x51fa;&#x73b0;&#x9f3b;&#x5835;&#x3001;&#x55c5;&#x89c9;&#x51cf;&#x9000;&#x3001;&#x6d41;&#x6d95;&#x53ca;&#x5934;&#x9762;&#x90e8;&#x75bc;&#x75db;&#x7b49;&#x75c7;&#x72b6;&#xff0c;&#x5bf9;&#x751f;&#x6d3b;&#x8d28;&#x91cf;&#x9020;&#x6210;&#x663e;&#x8457;&#x5f71;&#x54cd;&#x3002; <b>&#x65b9;&#x6cd5;&#xff1a;</b>&#x53f8;&#x666e;&#x5947;&#x62dc;&#x5355;&#x6297;&#x901a;&#x8fc7;&#x9776;&#x5411;&#x767d;&#x7ec6;&#x80de;&#x4ecb;&#x7d20;-4&#x53d7;&#x4f53;&#x3b1;&#x4e9a;&#x57fa;&#xff08;IL-4 receptor &#x3b1;&#xff0c;IL-4R&#x3b1;&#xff09;&#xff0c;&#x963b;&#x65ad;IL-4&#x548c;IL-13&#x4fe1;&#x53f7;&#x901a;&#x8def;&#xff0c;&#x4ece;&#x800c;&#x53d1;&#x6325;&#x4f5c;&#x7528;&#x3002;&#x672c;&#x7814;&#x7a76;&#x57fa;&#x4e8e;CROWNS-2 &#x2162;&#x671f;&#x4e34;&#x5e8a;&#x7814;&#x7a76;&#x5f00;&#x5c55;&#x4e8b;&#x540e;&#x5206;&#x6790;&#xff0c;&#x91c7;&#x7528;&#x9f3b;&#x7aa6;&#x7ed3;&#x5c40;&#x6d4b;&#x8bd5;22&#x6761;&#x91cf;&#x8868;&#xff08;22-item sinonasal outcome test&#xff0c;SNOT-22&#xff09;&#x8bc4;&#x4f30;&#x53f8;&#x666e;&#x5947;&#x62dc;&#x5355;&#x6297;&#x5bf9;CRSwNP&#x60a3;&#x8005;&#x5728;&#x5404;&#x751f;&#x6d3b;&#x8d28;&#x91cf;&#x75c7;&#x72b6;&#x57df;&#x7684;&#x6539;&#x5584;&#x60c5;&#x51b5;&#x3002; <b>&#x7ed3;&#x679c;&#xff1a;</b>&#x5728;&#x53cc;&#x76f2;&#x671f;&#x5185;&#xff0c;&#x4e0e;&#x5b89;&#x6170;&#x5242;&#x76f8;&#x6bd4;&#xff0c;&#x53f8;&#x666e;&#x5947;&#x62dc;&#x5355;&#x6297;&#x663e;&#x8457;&#x6539;&#x5584;&#x4e86;&#x60a3;&#x8005;&#x7684;&#x9f3b;&#x90e8;&#x75c7;&#x72b6;&#x3001;&#x8033;/&#x9762;&#x90e8;&#x75c7;&#x72b6;&#x3001;&#x7761;&#x7720;&#x969c;&#x788d;&#x53ca;&#x60c5;&#x7eea;&#x7b49;&#x591a;&#x4e2a;SNOT-22&#x75c7;&#x72b6;&#x57df;&#x8bc4;&#x5206;&#x3002;&#x4e0a;&#x8ff0;&#x6539;&#x5584;&#x5728;&#x5f00;&#x653e;&#x6807;&#x7b7e;&#x6269;&#x5c55;&#x7814;&#x7a76;&#x53ca;&#x540e;&#x7eed;&#x5b89;&#x5168;&#x968f;&#x8bbf;&#x9636;&#x6bb5;&#x5f97;&#x4ee5;&#x7ef4;&#x6301;&#x6216;&#x8fdb;&#x4e00;&#x6b65;&#x6539;&#x5584;&#x3002; <b>&#x7ed3;&#x8bba;&#xff1a;</b>&#x53f8;&#x666e;&#x5947;&#x62dc;&#x5355;&#x6297;&#x53ef;&#x5728;&#x591a;&#x4e2a;&#x751f;&#x6d3b;&#x8d28;&#x91cf;&#x7ef4;&#x5ea6;&#x4e3a;CRSwNP&#x60a3;&#x8005;&#x5e26;&#x6765;&#x5feb;&#x901f;&#x4e14;&#x663e;&#x8457;&#x7684;&#x4e34;&#x5e8a;&#x83b7;&#x76ca;&#xff0c;&#x5e76;&#x5177;&#x6709;&#x826f;&#x597d;&#x7684;&#x7597;&#x6548;&#x6301;&#x7eed;&#x6027;&#xff0c;&#x4e3a;CRSwNP&#x60a3;&#x8005;&#x7684;&#x957f;&#x671f;&#x7ba1;&#x7406;&#x63d0;&#x4f9b;&#x4e86;&#x91cd;&#x8981;&#x7684;&#x4e34;&#x5e8a;&#x4f9d;&#x636e;&#x3002;.