Criteria to evaluate efficacy of biologics in asthma: a Global Asthma Association survey.

IF 2.9 3区医学 Q2 RESPIRATORY SYSTEM Expert Review of Respiratory Medicine Pub Date : 2023-01-01 Epub Date: 2023-06-26 DOI:10.1080/17476348.2023.2223986

Angelica Tiotiu, Andras Bikov, Francisco-Javier Gonzalez-Barcala, Sylvia Novakova, Plamena Novakova, Chong-Neto Herberto, Santus Pierachille, Ansotegui Ignacio, Ivancevich Juan Carlos, Kowal Krzysztof, Mihaicuta Stefan, Nedeva Denislava, Canonica Giorgio Walter, Bernstein Jonathan, Boulet Louis Philippe, Braido Fulvio

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Abstract

Background: Currently, there are no universally accepted criteria to measure the response to biologics available as treatment for severe asthma. This survey aims to establish consensus criteria to use for the evaluation of response to biologics after 4 months of treatment.

Method: Using Delphi methodology, a questionnaire including 10 items was validated by 13 international experts in asthma. The electronic survey circulated within the Interasma Scientific Network platform. For each item, five answers were proposed graduated from 'no importance' to 'very high importance' and by a score (A = 2 points; B = 4 points; C = 6 points; D = 8 points; E = 10 points). The final criteria were selected if the median score for the item was ≥7 and > 60% of responses according 'high importance' and 'very high importance'. All selected criteria were validated by the experts.

Results: Four criteria were identified: reduce daily systemic corticosteroids dose by ≥50%; decrease the number of asthma exacerbations requiring systemic corticosteroids by ≥50%; have no/minimal side effects; and obtain asthma control according validated questionnaires. The consensual decision was that ≥3 criteria define a good response to biologics.

Conclusions: Specific criteria were defined by an international panel of experts and could be used as tool in clinical practice.

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评估生物制剂治疗哮喘疗效的标准：全球哮喘协会调查。

背景：目前，还没有公认的标准来衡量对可用于治疗严重哮喘的生物制剂的反应。本调查旨在建立共识标准，用于评估治疗4个月后对生物制品的反应。方法：采用德尔菲法，由13位国际哮喘专家对10个项目的问卷进行验证。电子调查在内部科学网络平台内分发。对于每个项目，提出了五个答案，从“不重要”到“非常重要”，并以分数（a = 2分；B = 4分；C = 6分；D = 8分；E = 10分）。如果项目的中位得分为 ≥7和 > 60%的回答符合“高度重要性”和“非常高度重要性”。所有选定的标准都经过了专家的验证。结果：确定了四个标准：通过 ≥50%；通过 ≥50%；无副作用/最小副作用；并根据经验证的问卷获得哮喘控制。双方同意的决定是 ≥3个标准定义了对生物制剂的良好反应。结论：具体标准由国际专家小组确定，可作为临床实践的工具。

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来源期刊

Expert Review of Respiratory Medicine RESPIRATORY SYSTEM-

CiteScore

6.80

自引率

2.60%

发文量

期刊介绍： Coverage will include the following key areas: - Prospects for new and emerging therapeutics - Epidemiology of disease - Preventive strategies - All aspects of COPD, from patient self-management to systemic effects of the disease and comorbidities - Improved diagnostic methods, including imaging techniques, biomarkers and physiological tests. - Advances in the treatment of respiratory infections and drug resistance issues - Occupational and environmental factors - Progress in smoking intervention and cessation methods - Disease and treatment issues for defined populations, such as children and the elderly - Respiratory intensive and critical care - Updates on the status and advances of specific disease areas, including asthma, HIV/AIDS-related disease, cystic fibrosis, COPD and sleep-disordered breathing morbidity