Real-World Data on Tezepelumab in Patients With Severe Asthma in Germany

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Abstract

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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德国重症哮喘患者使用替塞单抗的实际数据。
背景特珠单抗是一种阻断胸腺基质淋巴细胞素(TSLP)的新型生物制剂,已被批准用于治疗重症哮喘,与生物标志物水平或表型无关:目的:描述真实世界中替塞鲁单抗患者群的特征以及不同哮喘表型的疗效:我们对开始使用替塞单抗的重症哮喘患者进行了一项多中心回顾性研究。结果:我们共纳入了 129 名患者,平均年龄为 65 岁:我们共纳入了 129 名患者,平均年龄为(52.5 ± 13.1)岁,其中 59.7% 为女性。大多数患者(86.0%)的T2生物标志物增高,68.2%为过敏性表型,31.8%为嗜酸性表型。23.3%的患者未使用过生物制剂。22例(18.2%)患者因疑似副作用或疗效不佳而中断了替塞普鲁单抗治疗。随访6个月时,年化恶化率(AE)的中位数减少了-1 [-2.9; 0.0],长期接受口服皮质类固醇(OCS)治疗的患者口服皮质类固醇(OCS)剂量减少了-5 mg [-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,80.8% 的患者表现出治疗反应。T2高与T2低、早期发病与成年发病、嗜酸性粒细胞性与非嗜酸性粒细胞性哮喘之间的治疗反应无明显差异。曾接受过其他生物制剂治疗的患者治疗反应较差:在这个现实生活中的队列中,有很大一部分患者既往使用过生物制剂,而且包括不同的亚组,大多数患者对替塞普鲁单抗有反应。我们的数据进一步表明,替塞单抗具有节省类固醇的作用。
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来源期刊
CiteScore
11.10
自引率
9.60%
发文量
683
审稿时长
50 days
期刊介绍: JACI: In Practice is an official publication of the American Academy of Allergy, Asthma & Immunology (AAAAI). It is a companion title to The Journal of Allergy and Clinical Immunology, and it aims to provide timely clinical papers, case reports, and management recommendations to clinical allergists and other physicians dealing with allergic and immunologic diseases in their practice. The mission of JACI: In Practice is to offer valid and impactful information that supports evidence-based clinical decisions in the diagnosis and management of asthma, allergies, immunologic conditions, and related diseases. This journal publishes articles on various conditions treated by allergist-immunologists, including food allergy, respiratory disorders (such as asthma, rhinitis, nasal polyps, sinusitis, cough, ABPA, and hypersensitivity pneumonitis), drug allergy, insect sting allergy, anaphylaxis, dermatologic disorders (such as atopic dermatitis, contact dermatitis, urticaria, angioedema, and HAE), immunodeficiency, autoinflammatory syndromes, eosinophilic disorders, and mast cell disorders. The focus of the journal is on providing cutting-edge clinical information that practitioners can use in their everyday practice or to acquire new knowledge and skills for the benefit of their patients. However, mechanistic or translational studies without immediate or near future clinical relevance, as well as animal studies, are not within the scope of the journal.
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