XALOC-1：贝那利珠单抗治疗重症嗜酸性粒细胞性哮喘的2年临床缓解
2025/04/30
摘要
背景：目前缺乏关于接受生物制剂治疗的重症嗜酸性粒细胞性哮喘（SEA）患者长期临床缓解的真实世界数据。本研究描述了接受贝那利珠单抗治疗的SEA患者2年内的临床缓解情况。
研究问题：长期临床缓解是否可作为接受贝那利珠单抗治疗的SEA患者的可行目标？
研究设计与方法：XALOC-1是一项多国、回顾性、真实世界研究，纳入接受贝那利珠单抗治疗≤96周的成人SEA患者。评估患者在基线（第0周）、第48周和第96周时符合临床缓解标准（无急性发作、未使用维持性口服糖皮质激素[mOCS]、哮喘控制良好[哮喘控制测试（ACT）评分≥20或6项哮喘控制问卷（ACQ-6）评分≤0.75]）的比例。采用多变量逻辑回归分析评估基线人口学特征、临床特征与第48周和第96周临床缓解状态的关系。
结果：在1070例患者中，基线、第48周和第96周时分别有0.4%、39%和31%的患者达到3项临床缓解标准。在生物制剂初治和经治患者中，缓解率分别为43% vs. 32%（第48周）和36% vs. 23%（第96周）。基线较低的mOCS剂量（比值比[95% CI] 0.51 [0.34, 0.76]）、较低的体重指数（0.56 [0.36, 0.86]）和较高的峰值嗜酸性粒细胞计数（1.68 [1.05, 2.69]）与第96周达到临床缓解呈正相关。
结论：临床缓解是可行的治疗目标，约三分之一的SEA患者接受贝那利珠单抗治疗后可持续缓解长达2年。基线疾病负担较轻的患者更易实现缓解，提示需进一步研究早期启用生物制剂的潜在获益。
XALOC-1: Clinical remission over 2-years with benralizumab in severe eosinophilic asthma.
Girolamo, Pelaia; David J, Jackson; Parameswaran, Nair;
Abstrast
Background: Long-term real-world data on clinical remission in patients with severe eosinophilic asthma (SEA) receiving biologics are lacking. We describe clinical remission over 2 years in patients with SEA receiving benralizumab.
Research Question: Is long-term clinical remission a viable goal for patients with SEA receiving benralizumab?
Study Design And Methods: XALOC-1 is a multinational, retrospective, real-world program in adults with SEA who received benralizumab for ≤96 weeks. Percentages of patients meeting the components and composite of clinical remission (no exacerbations, no maintenance oral corticosteroid [mOCS] use, and well-controlled asthma [Asthma Control Test score ≥20 or 6-item Asthma Control Questionnaire score ≤0.75 ]) were assessed at Weeks 0, 48, and 96. The association between key baseline demographics, clinical characteristics, and clinical remission status was assessed at Weeks 48 and 96 using multivariable logistic regression analysis.
Results: Of 1070 patients, 0.4%, 39%, and 31% met the 3-component clinical remission criteria at Weeks 0, 48, and 96, respectively. In biologic-naïve and biologic-experienced patients, remission occurred in 43% and 32% (Week 48), and 36% and 23% (Week 96) of patients, respectively. Lower mOCS dose (odds ratio [95% confidence interval] 0.51 [0.34, 0.76]), lower body mass index (0.56 [0.36, 0.86]), and higher peak eosinophil count (1.68 [1.05, 2.69]) at baseline were positively associated with meeting criteria for clinical remission at Week 96.
Interpretation: Clinical remission is a realistic goal, sustainable up to 2 years in around one-third of patients with SEA receiving benralizumab. Remission was more likely in patients with lower baseline disease burden, suggesting that further research is warranted regarding whether earlier initiation of a biologic may be beneficial.
背景：目前缺乏关于接受生物制剂治疗的重症嗜酸性粒细胞性哮喘（SEA）患者长期临床缓解的真实世界数据。本研究描述了接受贝那利珠单抗治疗的SEA患者2年内的临床缓解情况。
研究问题：长期临床缓解是否可作为接受贝那利珠单抗治疗的SEA患者的可行目标？
研究设计与方法：XALOC-1是一项多国、回顾性、真实世界研究，纳入接受贝那利珠单抗治疗≤96周的成人SEA患者。评估患者在基线（第0周）、第48周和第96周时符合临床缓解标准（无急性发作、未使用维持性口服糖皮质激素[mOCS]、哮喘控制良好[哮喘控制测试（ACT）评分≥20或6项哮喘控制问卷（ACQ-6）评分≤0.75]）的比例。采用多变量逻辑回归分析评估基线人口学特征、临床特征与第48周和第96周临床缓解状态的关系。
结果：在1070例患者中，基线、第48周和第96周时分别有0.4%、39%和31%的患者达到3项临床缓解标准。在生物制剂初治和经治患者中，缓解率分别为43% vs. 32%（第48周）和36% vs. 23%（第96周）。基线较低的mOCS剂量（比值比[95% CI] 0.51 [0.34, 0.76]）、较低的体重指数（0.56 [0.36, 0.86]）和较高的峰值嗜酸性粒细胞计数（1.68 [1.05, 2.69]）与第96周达到临床缓解呈正相关。
结论：临床缓解是可行的治疗目标，约三分之一的SEA患者接受贝那利珠单抗治疗后可持续缓解长达2年。基线疾病负担较轻的患者更易实现缓解，提示需进一步研究早期启用生物制剂的潜在获益。
（中日友好医院呼吸与危重症医学科 万静萱 摘译 林江涛 审校）
（Chest 2025 Apr 19;0(0)；DOI: 10.1164/rccm.202408-1544OC. 10.1016/j.chest.2025.04.011.IF: 8.308）
XALOC-1: Clinical remission over 2-years with benralizumab in severe eosinophilic asthma.
Girolamo, Pelaia; David J, Jackson; Parameswaran, Nair;
Abstrast
Background: Long-term real-world data on clinical remission in patients with severe eosinophilic asthma (SEA) receiving biologics are lacking. We describe clinical remission over 2 years in patients with SEA receiving benralizumab.
Research Question: Is long-term clinical remission a viable goal for patients with SEA receiving benralizumab?
Study Design And Methods: XALOC-1 is a multinational, retrospective, real-world program in adults with SEA who received benralizumab for ≤96 weeks. Percentages of patients meeting the components and composite of clinical remission (no exacerbations, no maintenance oral corticosteroid [mOCS] use, and well-controlled asthma [Asthma Control Test score ≥20 or 6-item Asthma Control Questionnaire score ≤0.75 ]) were assessed at Weeks 0, 48, and 96. The association between key baseline demographics, clinical characteristics, and clinical remission status was assessed at Weeks 48 and 96 using multivariable logistic regression analysis.
Results: Of 1070 patients, 0.4%, 39%, and 31% met the 3-component clinical remission criteria at Weeks 0, 48, and 96, respectively. In biologic-naïve and biologic-experienced patients, remission occurred in 43% and 32% (Week 48), and 36% and 23% (Week 96) of patients, respectively. Lower mOCS dose (odds ratio [95% confidence interval] 0.51 [0.34, 0.76]), lower body mass index (0.56 [0.36, 0.86]), and higher peak eosinophil count (1.68 [1.05, 2.69]) at baseline were positively associated with meeting criteria for clinical remission at Week 96.
Interpretation: Clinical remission is a realistic goal, sustainable up to 2 years in around one-third of patients with SEA receiving benralizumab. Remission was more likely in patients with lower baseline disease burden, suggesting that further research is warranted regarding whether earlier initiation of a biologic may be beneficial.
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