Riyad Omar Al-Lehebi, Mona Al Ahmad, Venkata Nagarjuna Maturu, Alejandra Galeano Mesa, Bassam Mahboub, Elizabeth Garcia, Patricia Fernandez, Claudia Soares, Gabriela Abreu, Debora dos Santos, Juliana Queiroz, Alejandro Raimondi, Maria Laucho-Contreras, Saeed Noibi, Gur Levy, Sevim Bavbek
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Primary endpoint: incident rate ratio (IRR) of clinically significant exacerbations (CSEs). Key secondary endpoints: healthcare resource utilisation (HCRU), oral corticosteroid (OCS) use, lung function and symptom control (Asthma Control Test [ACT] scores).</p><h3>Results</h3><p>Overall, 525 patients with SA burden pre-initiation (geometric mean blood eosinophil count [BEC] 490.7 cells/µl; 31.4% prior biologic use; 37.3% obese) received at least one dose of mepolizumab 100 mg subcutaneously. Post-initiation, a significant reduction in CSEs was observed (76% [<i>p</i> < 0.001]; IRR [95% confidence interval] 0.24 [0.19–0.30]); 72.0% of patients had no CSEs. Mepolizumab treatment led to a reduction in OCS use (52.8% pre-initiation vs. 16.6% post-initiation) and a mean (standard deviation [SD]) change in OCS dose of − 18.1 (20.7) mg post-initiation; 36.1% of patients became OCS-free. Fewer patients were hospitalised post-initiation (22.5% pre-initiation vs. 6.9% post-initiation). 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引用次数: 0
摘要
简介：纽卡拉疗效研究（NEST）评估了甲泼尼珠单抗对重症哮喘患者的疗效：Nucala 有效性研究（NEST）评估了美泊利珠单抗对严重哮喘（SA）患者的疗效：在哥伦比亚、智利、印度、土耳其、沙特阿拉伯、阿拉伯联合酋长国、科威特、阿曼和卡塔尔开展了一项多国、双向、自控、观察性队列研究。主要终点：临床症状明显加重（CSE）的发生率（IRR）。主要次要终点：医疗资源利用率（HCRU）、口服皮质类固醇（OCS）使用率、肺功能和症状控制率（哮喘控制测试 [ACT] 评分）：总体而言，525 名启动前有 SA 负担的患者（几何平均血液嗜酸性粒细胞计数 [BEC] 490.7 cells/µl；31.4% 曾使用过生物制剂；37.3% 肥胖）接受了至少一剂 100 毫克的 mepolizumab 皮下注射。开始治疗后，观察到 CSE 明显减少（76% [p 结论："CSE 明显减少"）：在所研究的国家中，通过显著减少 CSE、减少 OCS 使用和 HCRU、改善肺功能和哮喘控制，麦泊珠单抗可有效减轻 SA 的负担，从而改善 SA 患者与健康相关的生活质量。本文附有图表摘要。
Real-World Effectiveness of Mepolizumab in Severe Asthma: Results from the Multi-country, Self-controlled Nucala Effectiveness Study (NEST)
Introduction
The Nucala Effectiveness Study (NEST) assessed the effectiveness of mepolizumab in patients with severe asthma (SA) in countries previously underrepresented in real-world studies.
Methods
A multi-country, bi-directional, self-controlled, observational cohort study conducted in Colombia, Chile, India, Türkiye, Saudi Arabia, United Arab Emirates, Kuwait, Oman, and Qatar. Historical and/or prospective data from patients with SA were assessed 12 months pre- and post-mepolizumab initiation. Primary endpoint: incident rate ratio (IRR) of clinically significant exacerbations (CSEs). Key secondary endpoints: healthcare resource utilisation (HCRU), oral corticosteroid (OCS) use, lung function and symptom control (Asthma Control Test [ACT] scores).
Results
Overall, 525 patients with SA burden pre-initiation (geometric mean blood eosinophil count [BEC] 490.7 cells/µl; 31.4% prior biologic use; 37.3% obese) received at least one dose of mepolizumab 100 mg subcutaneously. Post-initiation, a significant reduction in CSEs was observed (76% [p < 0.001]; IRR [95% confidence interval] 0.24 [0.19–0.30]); 72.0% of patients had no CSEs. Mepolizumab treatment led to a reduction in OCS use (52.8% pre-initiation vs. 16.6% post-initiation) and a mean (standard deviation [SD]) change in OCS dose of − 18.1 (20.7) mg post-initiation; 36.1% of patients became OCS-free. Fewer patients were hospitalised post-initiation (22.5% pre-initiation vs. 6.9% post-initiation). Improvements in mean (SD) forced expiratory volume in 1 s (62.8 [20.2]% pre-initiation vs. 73.0 [22.7]% post-initiation) and ACT scores (15.0% pre-initiation vs. 64.5% of patients post-initiation with well-controlled asthma) were observed. Proportion of patients with BEC ≥ 500 cells/µl decreased from 84.4% pre-initiation to 18.1% post-initiation.
Conclusion
Mepolizumab was effective in reducing the burden of SA by significantly reducing CSEs, reducing OCS use and HCRU, and improving lung function and asthma control, which could translate to improvements in health-related quality of life in patients with SA and high OCS dependency in the countries studied. A graphical abstract is available with this article.
期刊介绍：
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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