重度哮喘患者接受特泽鲁单抗治疗一年后吸入糖皮质激素的依从性和临床结局
2025/11/28
摘要
背景：高剂量吸入性皮质类固醇（ICS）与不良反应相关。在接受抗白细胞介素 - 5/5R（IL - 5/5R）治疗的同时减少 ICS 的使用，可能会导致部分患者的临床疗效降低。
目的：本研究旨在探讨更广泛的 2 型炎症（T2）抑制剂抗胸腺基质淋巴细胞生成素（TSLP）特泽鲁单抗是否能在不产生有害临床后果的情况下，减少 ICS 的使用。
方法：采用药物持有率（MPR）方法计算重度哮喘患者在开始使用特泽鲁单抗治疗前 12 个月和治疗后 12 个月对 ICS/长效β₂受体激动剂（LABA）的依从性，并将其分为差（<0.5）、欠佳（0.51 - 0.74）和良好（≥0.75）三个等级。比较不同 ICS 依从性亚组在 1 年时的临床结局，包括病情加重率、哮喘控制问卷 6 项版（ACQ - 6）评分、第 1 秒用力呼气容积（FEV₁）、实现临床缓解的能力以及 T2 生物标志物水平。
结果：纳入了 152 例使用特泽鲁单抗治疗的重度哮喘成年患者。治疗 12 个月末，中位 MPR 从基线时的 1.0（0.83 - 1.08）显著降至 0.83（0.58 - 1），p = 0.009。患者中 ICS 依从性良好的占 69.1%，欠佳的占 12.5%，差的占 18.4%。在 1 年时，所有临床结局指标的改善情况以及生物学缓解率在不同 ICS 依从性组之间相似（所有 p > 0.05）。
结论：重度哮喘患者开始使用特泽鲁单抗治疗后，ICS 依从性下降与特泽鲁单抗临床疗效降低（包括实现缓解的能力）并无关联。相似的生物学缓解率进一步表明，抗 TSLP 的广泛抗 T2 作用可能足以安全地减少 ICS 的暴露。
Adherence to Inhaled Corticosteroids and Clinical Outcomes Following a Year of Tezepelumab Therapy for Severe Asthma
Grainne d'Ancona, Faizan Haris, Jessica Gates, Niall Stewart-Kelcher, Linda Green, Jodie Lam, Mariana Fernandes, Louise Thomson, Cris Roxas, Zijing Yang, Jaideep Dhariwal, Alexandra M Nanzer, David J Jackson
Abstract
Background: High-dose inhaled corticosteroid (ICS) are associated with adverse effects. Reductions in ICS use whilst treated with anti-IL5/5R therapies can lead to reduced clinical effectiveness in some patients.
Objective: This study explored whether the broader anti-T2 effects of the anti-TSLP therapy tezepelumab permitted a reduction in ICS use without deleterious clinical consequences.
Methods: Adherence to ICS/LABA in the 12 months before and 12 months after commencing tezepelumab for severe asthma was calculated using medicines possession ratio (MPR) methodology and classified as poor (<0.5), suboptimal (0.51-0.74) and good (≥0.75). Clinical outcomes including exacerbation rate, ACQ-6 score, FEV1 and the ability to achieve clinical remission, as well as T2 biomarker levels at 1 year were compared across ICS adherence sub-groups.
Results: 152 adults with severe asthma who commenced tezepelumab were included. At the end of 12 months treatment, there was a significant reduction in the median MPR from 1.0 (0.83-1.08) at baseline to 0.83 (0.58-1), p=0.009. ICS adherence was good in 69.1%, suboptimal in 12.5% and poor in 18.4% of patients. At 1 year, improvements in all clinical outcome measures as well as rates of biological remission were similar across ICS adherence groups (all p>0.05).
Conclusion: A fall in ICS adherence following initiation of tezepelumab for severe asthma was not associated with evidence of reduced clinical effectiveness of tezepelumab, including the ability to achieve remission. Similar rates of biological remission further suggests that the broad anti-T2 effect of anti-TSLP may be sufficient to permit a safe reduction in ICS exposure.
背景：高剂量吸入性皮质类固醇（ICS）与不良反应相关。在接受抗白细胞介素 - 5/5R（IL - 5/5R）治疗的同时减少 ICS 的使用，可能会导致部分患者的临床疗效降低。
目的：本研究旨在探讨更广泛的 2 型炎症（T2）抑制剂抗胸腺基质淋巴细胞生成素（TSLP）特泽鲁单抗是否能在不产生有害临床后果的情况下，减少 ICS 的使用。
方法：采用药物持有率（MPR）方法计算重度哮喘患者在开始使用特泽鲁单抗治疗前 12 个月和治疗后 12 个月对 ICS/长效β₂受体激动剂（LABA）的依从性，并将其分为差（<0.5）、欠佳（0.51 - 0.74）和良好（≥0.75）三个等级。比较不同 ICS 依从性亚组在 1 年时的临床结局，包括病情加重率、哮喘控制问卷 6 项版（ACQ - 6）评分、第 1 秒用力呼气容积（FEV₁）、实现临床缓解的能力以及 T2 生物标志物水平。
结果：纳入了 152 例使用特泽鲁单抗治疗的重度哮喘成年患者。治疗 12 个月末，中位 MPR 从基线时的 1.0（0.83 - 1.08）显著降至 0.83（0.58 - 1），p = 0.009。患者中 ICS 依从性良好的占 69.1%，欠佳的占 12.5%，差的占 18.4%。在 1 年时，所有临床结局指标的改善情况以及生物学缓解率在不同 ICS 依从性组之间相似（所有 p > 0.05）。
结论：重度哮喘患者开始使用特泽鲁单抗治疗后，ICS 依从性下降与特泽鲁单抗临床疗效降低（包括实现缓解的能力）并无关联。相似的生物学缓解率进一步表明，抗 TSLP 的广泛抗 T2 作用可能足以安全地减少 ICS 的暴露。
（中日友好医院呼吸与危重症医学科 李红雯 摘译 林江涛 审校）
（J Allergy Clin Immunol Pract. 2025 Nov 4:S2213-2198(25)01025-6. doi: 10.1016/j.jaip.2025.10.038.）
Adherence to Inhaled Corticosteroids and Clinical Outcomes Following a Year of Tezepelumab Therapy for Severe Asthma
Grainne d'Ancona, Faizan Haris, Jessica Gates, Niall Stewart-Kelcher, Linda Green, Jodie Lam, Mariana Fernandes, Louise Thomson, Cris Roxas, Zijing Yang, Jaideep Dhariwal, Alexandra M Nanzer, David J Jackson
Abstract
Background: High-dose inhaled corticosteroid (ICS) are associated with adverse effects. Reductions in ICS use whilst treated with anti-IL5/5R therapies can lead to reduced clinical effectiveness in some patients.
Objective: This study explored whether the broader anti-T2 effects of the anti-TSLP therapy tezepelumab permitted a reduction in ICS use without deleterious clinical consequences.
Methods: Adherence to ICS/LABA in the 12 months before and 12 months after commencing tezepelumab for severe asthma was calculated using medicines possession ratio (MPR) methodology and classified as poor (<0.5), suboptimal (0.51-0.74) and good (≥0.75). Clinical outcomes including exacerbation rate, ACQ-6 score, FEV1 and the ability to achieve clinical remission, as well as T2 biomarker levels at 1 year were compared across ICS adherence sub-groups.
Results: 152 adults with severe asthma who commenced tezepelumab were included. At the end of 12 months treatment, there was a significant reduction in the median MPR from 1.0 (0.83-1.08) at baseline to 0.83 (0.58-1), p=0.009. ICS adherence was good in 69.1%, suboptimal in 12.5% and poor in 18.4% of patients. At 1 year, improvements in all clinical outcome measures as well as rates of biological remission were similar across ICS adherence groups (all p>0.05).
Conclusion: A fall in ICS adherence following initiation of tezepelumab for severe asthma was not associated with evidence of reduced clinical effectiveness of tezepelumab, including the ability to achieve remission. Similar rates of biological remission further suggests that the broad anti-T2 effect of anti-TSLP may be sufficient to permit a safe reduction in ICS exposure.
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血嗜酸性粒细胞早期短暂增多不影响度普利尤单抗对中重度哮喘患者的长期疗效
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高血清TSLP是迟发性，长病程，嗜酸性粒细胞性哮喘的特征
