Real World Biologic Use and Switch Patterns in Severe Asthma: Data from the International Severe Asthma Registry and the US CHRONICLE Study.
Real World Biologic Use and Switch Patterns in Severe Asthma: Data from the International Severe Asthma Registry and the US CHRONICLE Study.
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DOI：
10.2147/jaa.s328653
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发表时间：
2022
影响因子：
3.2
通讯作者：
Price DB
中科院分区：
文献类型：
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作者：
Menzies-Gow AN;McBrien C;Unni B;Porsbjerg CM;Al-Ahmad M;Ambrose CS;Dahl Assing K;von Bülow A;Busby J;Cosio BG;FitzGerald JM;Garcia Gil E;Hansen S;aHeaney LG;Hew M;Jackson DJ;Kallieri M;Loukides S;Lugogo NL;Papaioannou AI;Larenas-Linnemann D;Moore WC;Perez-de-Llano LA;Rasmussen LM;Schmid JM;Siddiqui S;Alacqua M;Tran TN;Suppli Ulrik C;Upham JW;Wang E;Bulathsinhala L;Carter VA;Chaudhry I;Eleangovan N;Murray RB;Price CA;Price DB
国际登记研究为描述当前临床实践中使用生物制剂治疗重度哮喘提供了机会。我们的目的是描述严重哮喘生物制品使用的真实全球模式（持续、转换和停药），阐明这些模式背后的原因，并检查相关的患者水平因素。这是一项历史性队列研究，包括入组国际重度哮喘登记研究（ISAR; http://isaregistries.org，2015-2020）或CHRONICLE研究（2018-2020）并接受生物制剂治疗的重度哮喘成人。纳入了11个国家（保加利亚、加拿大、丹麦、希腊、意大利、日本、科威特、韩国、西班牙、英国和美国）。生物利用模式定义为：1）继续使用初始生物制剂; 2）停止生物制剂治疗;或3）改用另一种生物制剂。记录停药/转换的原因，并进行组间比较。共纳入3531例患者。奥马珠单抗是2015年最常见的初始生物制剂（88.2%），贝那利珠单抗是2019年最常见的初始生物制剂（29.6%）。大多数患者（79%; 2791/3531）继续使用第一种生物制剂; 10.2%（356/3531）停用; 10.8%（384/3531）转换。最常见的首次转换是从奥马珠单抗转换为抗IL-5/5 R（49.6%; 187/377）。最常见的后续转换是从一种抗IL-5/5 R转换为另一种抗IL-5/5 R（44.4%; 20/45）。疗效不足和/或不良反应是停药/转换的最常见原因。停止/转换的患者更有可能出现基线血嗜酸性粒细胞计数和加重率较高、肺功能较低和医疗保健资源利用率较高的情况。对持续、停止或转换生物制剂的现实模式的描述增强了我们对全球生物制剂使用的理解。前瞻性研究涉及结构化转换标准，可以确定最佳策略，以确定患者谁可能受益于转换。
International registries provide opportunities to describe use of biologics for treating severe asthma in current clinical practice. Our aims were to describe real-life global patterns of biologic use (continuation, switches, and discontinuations) for severe asthma, elucidate reasons underlying these patterns, and examine associated patient-level factors. This was a historical cohort study including adults with severe asthma enrolled into the International Severe Asthma Registry (ISAR; http://isaregistries.org, 2015–2020) or the CHRONICLE Study (2018–2020) and treated with a biologic. Eleven countries were included (Bulgaria, Canada, Denmark, Greece, Italy, Japan, Kuwait, South Korea, Spain, UK, and USA). Biologic utilization patterns were defined: 1) continuing initial biologic; 2) stopping biologic treatment; or 3) switching to another biologic. Reasons for discontinuation/switching were recorded and comparisons drawn between groups. A total of 3531 patients were included. Omalizumab was the most common initial biologic in 2015 (88.2%) and benralizumab in 2019 (29.6%). Most patients (79%; 2791/3531) continued their first biologic; 10.2% (356/3531) stopped; 10.8% (384/3531) switched. The most frequent first switch was from omalizumab to an anti–IL-5/5R (49.6%; 187/377). The most common subsequent switch was from one anti–IL-5/5R to another (44.4%; 20/45). Insufficient efficacy and/or adverse effects were the most frequent reasons for stopping/switching. Patients who stopped/switched were more likely to have a higher baseline blood eosinophil count and exacerbation rate, lower lung function, and greater health care resource utilization. The description of real-life patterns of continuing, stopping, or switching biologics enhances our understanding of global biologic use. Prospective studies involving structured switching criteria could ascertain optimal strategies to identify patients who may benefit from switching.