德国严重哮喘患者中特折鲁单抗的真实数据
2024/07/30
摘要
背景：特折鲁单抗是一种新型生物制剂，可阻断胸腺基质淋巴生成素，无论生物标志物水平或表型如何，均被批准用于严重哮喘。
目的：描述真实世界中的特折鲁单抗患者队列和不同哮喘表型的疗效。
方法：我们对开始使用特折鲁单抗的严重哮喘患者进行了一项回顾性、多中心研究。在 3 个月和6个月时评估临床反应。
结果：我们纳入了129名患者,平均年龄为52.5±13.1岁,59.7%为女性。大多数 (86.0%) 患者的 2 型 (T2) 生物标志物增加,68.2% 为过敏性,31.8%为嗜酸性表型。23.3% 的患者没有接受过生物制剂治疗。22名(18.2%) 患者因疑似副作用或疗效不足而中止了 tezepelumab 治疗。在6个月的随访中,年化恶化率的中位数降低为-1 [第25百分位数;75% 百分位数{-2.9; 0.0}],长期口服皮质类固醇治疗患者的口服皮质类固醇剂量减少为-5毫克 [-10; 0] ,哮喘控制测试 (ACT) 提高了2 [0; 5] 分。根据生物哮喘反应评分 (Biologic Asthma Response Score) 显示,治疗反应为80.8%。T2高与T2低、早发与成年发病、嗜酸性哮喘与非嗜酸性哮喘之间的治疗反应没有显著差异。先前接受其他生物制剂治疗与治疗反应较差有关。
结论：这个真实的队列中，包括很大一部分有既往生物制剂使用史的患者，包括各种亚组，大多数患者对特折鲁单抗有反应。我们的数据进一步表明特折鲁单抗可以减少类固醇的使用。
Real-World Data on Tezepelumab in Patients With Severe Asthma in Germany.
Leonie, Biener; Carlo, Mümmler; Christopher Alexander
Abstrast
Background：Tezepelumab is a novel biologic blocking thymic stromal lymphopoetin, approved for severe asthma irrespective of biomarker levels or phenotype.
Objective: To characterize a real-world tezepelumab patient cohort and the efficacy among various asthma phenotypes.
Methods: We performed a retrospective, multicenter study on patients with severe asthma initiating tezepelumab. Clinical response was evaluated at 3 and 6 months.
Results：We included 129 patients with an average age of 52.5 ± 13.1 years, 59.7% were female. The majority (86.0%) had increased type 2 (T2) biomarkers, 68.2% an allergic and 31.8% an eosinophilic phenotype. 23.3% of patients were biologic-naive. 22 (18.2%) patients discontinued tezepelumab therapy owing to suspected side effects or insufficient efficacy. At 6 months' follow-up, median reduction in annualized exacerbation rate was-1 [25th percentile; 75% percentile {-2.9; 0.0}], the reduction of oral corticosteroid dose among patients with long-term oral corticosteroid therapy was -5 mg [-10; 0] and the Asthma Control Test (ACT) improved by 2 [0; 5] points. A treatment response according to Biologic Asthma Response Score of 80.8% was demonstrated. There were no significant differences in treatment response between T2-high versus T2-low, early- versus adult-onset and eosinophilic versus non-eosinophilic asthma. Prior treatment with other biologics was associated with inferior treatment response.
Conclusions: In this real-life cohort, including a large proportion of patients with history of previous biologic use and encompassing various subgroups, the majority responded to tezepelumab. Our data further suggest a steroid-sparing effect of tezepelumab.
背景：特折鲁单抗是一种新型生物制剂，可阻断胸腺基质淋巴生成素，无论生物标志物水平或表型如何，均被批准用于严重哮喘。
目的：描述真实世界中的特折鲁单抗患者队列和不同哮喘表型的疗效。
方法：我们对开始使用特折鲁单抗的严重哮喘患者进行了一项回顾性、多中心研究。在 3 个月和6个月时评估临床反应。
结果：我们纳入了129名患者,平均年龄为52.5±13.1岁,59.7%为女性。大多数 (86.0%) 患者的 2 型 (T2) 生物标志物增加,68.2% 为过敏性,31.8%为嗜酸性表型。23.3% 的患者没有接受过生物制剂治疗。22名(18.2%) 患者因疑似副作用或疗效不足而中止了 tezepelumab 治疗。在6个月的随访中,年化恶化率的中位数降低为-1 [第25百分位数;75% 百分位数{-2.9; 0.0}],长期口服皮质类固醇治疗患者的口服皮质类固醇剂量减少为-5毫克 [-10; 0] ,哮喘控制测试 (ACT) 提高了2 [0; 5] 分。根据生物哮喘反应评分 (Biologic Asthma Response Score) 显示,治疗反应为80.8%。T2高与T2低、早发与成年发病、嗜酸性哮喘与非嗜酸性哮喘之间的治疗反应没有显著差异。先前接受其他生物制剂治疗与治疗反应较差有关。
结论：这个真实的队列中，包括很大一部分有既往生物制剂使用史的患者，包括各种亚组，大多数患者对特折鲁单抗有反应。我们的数据进一步表明特折鲁单抗可以减少类固醇的使用。
(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)
(J Allergy Clin Immunol Pract 2024 Jun 10;0(0); doi: 10.1016/j.jaip.2024.05.052. IF：7.574)
(J Allergy Clin Immunol Pract 2024 Jun 10;0(0); doi: 10.1016/j.jaip.2024.05.052. IF：7.574)
Real-World Data on Tezepelumab in Patients With Severe Asthma in Germany.
Leonie, Biener; Carlo, Mümmler; Christopher Alexander
Abstrast
Background：Tezepelumab is a novel biologic blocking thymic stromal lymphopoetin, approved for severe asthma irrespective of biomarker levels or phenotype.
Objective: To characterize a real-world tezepelumab patient cohort and the efficacy among various asthma phenotypes.
Methods: We performed a retrospective, multicenter study on patients with severe asthma initiating tezepelumab. Clinical response was evaluated at 3 and 6 months.
Results：We included 129 patients with an average age of 52.5 ± 13.1 years, 59.7% were female. The majority (86.0%) had increased type 2 (T2) biomarkers, 68.2% an allergic and 31.8% an eosinophilic phenotype. 23.3% of patients were biologic-naive. 22 (18.2%) patients discontinued tezepelumab therapy owing to suspected side effects or insufficient efficacy. At 6 months' follow-up, median reduction in annualized exacerbation rate was-1 [25th percentile; 75% percentile {-2.9; 0.0}], the reduction of oral corticosteroid dose among patients with long-term oral corticosteroid therapy was -5 mg [-10; 0] and the Asthma Control Test (ACT) improved by 2 [0; 5] points. A treatment response according to Biologic Asthma Response Score of 80.8% was demonstrated. There were no significant differences in treatment response between T2-high versus T2-low, early- versus adult-onset and eosinophilic versus non-eosinophilic asthma. Prior treatment with other biologics was associated with inferior treatment response.
Conclusions: In this real-life cohort, including a large proportion of patients with history of previous biologic use and encompassing various subgroups, the majority responded to tezepelumab. Our data further suggest a steroid-sparing effect of tezepelumab.
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Mepolizumab在重症哮喘中消除炎症但保留稳态嗜酸性粒细胞
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中度与剧烈运动训练对成人哮喘预后的影响
