Tiotiu Angelica, Bikov Andras, Gonzalez-Barcala Francisco-Javier, Novakova Silviya, Novakova Plamena, Chong-Neto Herberto, Santus Pierachille, Ansotegui Ignacio, Ivancevich Juan Carlos, Kowal Krzysztof, Mihaicuta Stefan, Nedeva Denislava, Canonica Gorgio Walter, Bernstein Jonathan A, Boulet Louis Philippe, Braido Fulvio
Department of Pulmonology, University Hospital of Nancy, Nancy, France.
Development, Adaptation and Disadvantage. Cardiorespiratory Regulations and Motor Control Unit (EA 3450 DevAh), University of Lorraine, Nancy, France.
Expert Rev Respir Med. 2023 Jan-Jun;17(6):507-516. doi: 10.1080/17476348.2023.2223986. Epub 2023 Jun 26.
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.
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.
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.
Specific criteria were defined by an international panel of experts and could be used as tool in clinical practice.
目前,尚无普遍接受的标准来衡量重度哮喘生物制剂治疗的反应。本调查旨在建立用于评估治疗4个月后生物制剂反应的共识标准。
采用德尔菲法,一份包含10项内容的问卷由13位国际哮喘专家进行了验证。电子调查问卷在国际哮喘科学网络平台上发布。对于每个项目,提出了五个答案,从“不重要”到“非常重要”进行分级,并给出一个分数(A = 2分;B = 4分;C = 6分;D = 8分;E = 10分)。如果项目的中位数得分≥7分,且“高重要性”和“非常高重要性”的回答比例>60%,则选择最终标准。所有选定的标准均经专家验证。
确定了四条标准:将每日全身用皮质类固醇剂量减少≥50%;将需要全身用皮质类固醇的哮喘急性发作次数减少≥50%;无/极少副作用;并根据经过验证的问卷实现哮喘控制。共识决定是,≥3条标准定义为对生物制剂的良好反应。
国际专家小组定义了具体标准,可作为临床实践中的工具。