Tezepelumab治疗重度哮喘的一年期临床缓解：TERESA单臂前瞻性研究
2026/06/01
摘要
背景：临床缓解已成为重度哮喘治疗中一项宏伟的目标，这使得治疗重点从单纯的症状缓解转向了长期的疾病进程改变。Tezepelumab 是一种靶向胸腺基质淋巴细胞生成素（TSLP）的单克隆抗体，已展现出广谱的抗炎活性。然而，评估 tezepelumab 实现临床缓解的前瞻性数据仍然有限，特别是在既往有过生物制剂治疗史的患者群体中。“Tezepelumab诱导的重度哮喘临床缓解”（TERESA）研究是一项多中心、前瞻性、单臂且由研究者发起的 4 期临床研究，旨在评估每 4 周接受一次 tezepelumab 治疗的未控制重度哮喘患者在第 52 周时的临床缓解情况。
方法：临床缓解被定义为：无哮喘急性发作、停用维持性口服皮质类固醇、ACQ-6 评分 ≤1.5 且肺功能保持稳定。次要终点包括完全缓解（即在临床缓解的基础上，加上 T2 型生物标志物呈阴性）。
结果：在入组的 107 例患者中（包含 50 例有生物制剂治疗史的患者），有 34.6%（95% CI：26.2, 44.0）的患者在第 52 周达到了临床缓解。观察到达到完全缓解的比例为 9.3%。未接受过生物制剂治疗（Biologic-naïve）的患者，其缓解率高于有过生物制剂治疗史（biologic-experienced）的患者（分别为 47.4% 对比 20.0%）。多变量逻辑回归分析确认了两个实现临床缓解的独立预测因素：既往未使用过生物制剂（调整后 OR：3.61，95% CI：1.29, 10.15）以及基线血嗜酸性粒细胞计数 ≥300 个/μL（调整后 OR：5.10，95% CI：1.23, 21.18）。
结论：在这项为期一年随访的单臂研究中，tezepelumab 在约三分之一的重度哮喘患者中实现了临床缓解，并且展现出了良好的安全性。较高的基线嗜酸性粒细胞计数和未接受过生物制剂治疗的状态是实现缓解的关键预测因素，这突显了 tezepelumab 在经过适当筛选的患者中实现疾病全面控制的潜力。
One-Year Clinical Remission with Tezepelumab in Severe Asthma: TERESA Single-Arm Prospective Study
Kan-O, K., Watanabe, H., Chibana, K., Suzukawa, M., Tanaka, A., Masaki, K., Ohta, S., Kabata, H., Asano, K., Ito, R., Inoue, H., Nakano, T., Kanda, H., Yamashita, T., Obase, Y., Kobayashi, K., Sugimoto, N., Ito, Y., Ogata, H., Takagi, K., … Okamoto, I.
Abstract
BACKGROUND:Clinical remission has emerged as an ambitious therapeutic goal in severe asthma, shifting emphasis from symptomatic relief to long-term disease modification. Tezepelumab, a monoclonal antibody targeting thymic stromal lymphopoietin, has demonstrated broad-spectrum anti-inflammatory activity. However, prospective data assessing clinical remission with tezepelumab, especially in biologic-experienced patients, remain limited. The Tezepelumab-induced Clinical Remission in Severe Asthma (TERESA) study is a multicenter, prospective, single-arm, investigator-initiated Phase 4 study evaluating clinical remission at week 52 in patients with uncontrolled severe asthma receiving tezepelumab every 4 weeks.
METHODS:Clinical remission was defined as the absence of asthma exacerbations, discontinuation of maintenance oral corticosteroids, an ACQ-6 score of ≤1.5, and stabilized lung function. Secondary endpoints included complete remission (clinical remission plus T2 biomarker negativity).
RESULTS:Among 107 patients enrolled (including 50 biologic-experienced), 34.6% (95% CI: 26.2, 44.0) achieved clinical remission at week 52. Complete remission was observed in 9.3%. Biologic-naïve patients demonstrated higher remission rates than biologic-experienced patients (47.4% versus 20.0%, respectively). Multivariable logistic regression identified absence of previous biologic use (adjusted OR: 3.61, 95% CI: 1.29, 10.15) and baseline blood eosinophil count ≥300 cells/μL (adjusted OR: 5.10, 95% CI: 1.23, 21.18) as independent predictors of clinical remission.
CONCLUSION:In this single-arm study with a one-year follow-up, tezepelumab achieved clinical remission in approximately one-third of patients with severe asthma, with a favorable safety profile. Higher baseline eosinophil count and biologic-naïve status were key predictors of remission, underscoring tezepelumab's potential to achieve comprehensive disease control in appropriately selected patients.
背景：临床缓解已成为重度哮喘治疗中一项宏伟的目标，这使得治疗重点从单纯的症状缓解转向了长期的疾病进程改变。Tezepelumab 是一种靶向胸腺基质淋巴细胞生成素（TSLP）的单克隆抗体，已展现出广谱的抗炎活性。然而，评估 tezepelumab 实现临床缓解的前瞻性数据仍然有限，特别是在既往有过生物制剂治疗史的患者群体中。“Tezepelumab诱导的重度哮喘临床缓解”（TERESA）研究是一项多中心、前瞻性、单臂且由研究者发起的 4 期临床研究，旨在评估每 4 周接受一次 tezepelumab 治疗的未控制重度哮喘患者在第 52 周时的临床缓解情况。
方法：临床缓解被定义为：无哮喘急性发作、停用维持性口服皮质类固醇、ACQ-6 评分 ≤1.5 且肺功能保持稳定。次要终点包括完全缓解（即在临床缓解的基础上，加上 T2 型生物标志物呈阴性）。
结果：在入组的 107 例患者中（包含 50 例有生物制剂治疗史的患者），有 34.6%（95% CI：26.2, 44.0）的患者在第 52 周达到了临床缓解。观察到达到完全缓解的比例为 9.3%。未接受过生物制剂治疗（Biologic-naïve）的患者，其缓解率高于有过生物制剂治疗史（biologic-experienced）的患者（分别为 47.4% 对比 20.0%）。多变量逻辑回归分析确认了两个实现临床缓解的独立预测因素：既往未使用过生物制剂（调整后 OR：3.61，95% CI：1.29, 10.15）以及基线血嗜酸性粒细胞计数 ≥300 个/μL（调整后 OR：5.10，95% CI：1.23, 21.18）。
结论：在这项为期一年随访的单臂研究中，tezepelumab 在约三分之一的重度哮喘患者中实现了临床缓解，并且展现出了良好的安全性。较高的基线嗜酸性粒细胞计数和未接受过生物制剂治疗的状态是实现缓解的关键预测因素，这突显了 tezepelumab 在经过适当筛选的患者中实现疾病全面控制的潜力。
（中日友好医院呼吸与危重症医学科 沈焜路 摘译 林江涛 审校）
（J Allergy Clin Immunol. 2026 May; DOI: 10.1016/j.jaci.2026.05.006）
（J Allergy Clin Immunol. 2026 May; DOI: 10.1016/j.jaci.2026.05.006）
One-Year Clinical Remission with Tezepelumab in Severe Asthma: TERESA Single-Arm Prospective Study
Kan-O, K., Watanabe, H., Chibana, K., Suzukawa, M., Tanaka, A., Masaki, K., Ohta, S., Kabata, H., Asano, K., Ito, R., Inoue, H., Nakano, T., Kanda, H., Yamashita, T., Obase, Y., Kobayashi, K., Sugimoto, N., Ito, Y., Ogata, H., Takagi, K., … Okamoto, I.
Abstract
BACKGROUND:Clinical remission has emerged as an ambitious therapeutic goal in severe asthma, shifting emphasis from symptomatic relief to long-term disease modification. Tezepelumab, a monoclonal antibody targeting thymic stromal lymphopoietin, has demonstrated broad-spectrum anti-inflammatory activity. However, prospective data assessing clinical remission with tezepelumab, especially in biologic-experienced patients, remain limited. The Tezepelumab-induced Clinical Remission in Severe Asthma (TERESA) study is a multicenter, prospective, single-arm, investigator-initiated Phase 4 study evaluating clinical remission at week 52 in patients with uncontrolled severe asthma receiving tezepelumab every 4 weeks.
METHODS:Clinical remission was defined as the absence of asthma exacerbations, discontinuation of maintenance oral corticosteroids, an ACQ-6 score of ≤1.5, and stabilized lung function. Secondary endpoints included complete remission (clinical remission plus T2 biomarker negativity).
RESULTS:Among 107 patients enrolled (including 50 biologic-experienced), 34.6% (95% CI: 26.2, 44.0) achieved clinical remission at week 52. Complete remission was observed in 9.3%. Biologic-naïve patients demonstrated higher remission rates than biologic-experienced patients (47.4% versus 20.0%, respectively). Multivariable logistic regression identified absence of previous biologic use (adjusted OR: 3.61, 95% CI: 1.29, 10.15) and baseline blood eosinophil count ≥300 cells/μL (adjusted OR: 5.10, 95% CI: 1.23, 21.18) as independent predictors of clinical remission.
CONCLUSION:In this single-arm study with a one-year follow-up, tezepelumab achieved clinical remission in approximately one-third of patients with severe asthma, with a favorable safety profile. Higher baseline eosinophil count and biologic-naïve status were key predictors of remission, underscoring tezepelumab's potential to achieve comprehensive disease control in appropriately selected patients.
上一篇：
没有了
下一篇：
Tezepelumab 在美国真实世界不同表型及代表性不足人群中的严重哮喘患者中的应用：Ⅳ 期 PASSAGE 研究
