Development of a Tool to Measure the Clinical Response to Biologic Therapy in Uncontrolled Severe Asthma: The FEV1, Exacerbations, Oral Corticosteroids, Symptoms Score.

Abstract

BACKGROUND:

There is a lack of tools to quantify the response to monoclonal antibodies (mAbs) holistically in severe uncontrolled asthma patients.

OBJECTIVE:

To develop a valid score to assist specialists in this clinical context.

METHODS:

The score was developed in four subsequent phases: (1) elaboration of the theoretical model of the construct intended to be measured (response to mAbs); (2) definition and selection of items and measurement instruments by Delphi survey; (3) weight assignment of the selected items by multicriteria decision analysis using the Potentially All Pairwise RanKings of All Possible Alternatives methodology using the 1000minds software; and (4) face validity assessment of the obtained score.

RESULTS:

Four core items, with different levels of response for each, were selected: severe exacerbations, oral corticosteroid use, symptoms (evaluated by Asthma Control Test), and bronchial obstruction (assessed by FEV1 percent predicted). Severe exacerbations and oral corticosteroid maintenance dose were weighted most heavily (38% each), followed by symptoms (13%) and FEV1 (11%). Higher scores in the weighted system indicate a better response and the range of responses runs from 0 (worsening) to 100 (best possible response). Face validity was high (intraclass correlation coefficient of 0.86).

CONCLUSIONS:

The FEV1, exacerbations, oral corticosteroids, symptoms score allows clinicians to quantify response in severe uncontrolled asthma patients who are being treated with mAbs.

• Authors: Luis Pérez de Llano, Ignacio Dávila, Eva Martínez-Moragón, Javier Domínguez-Ortega, Carlos Almonacid, Carlos Colás, Juan Luis García-Rivero, Loreto Carmona, María Jesús García de Yébenes, Borja G Cosío, FEOS Study Group
• Journal: The journal of allergy and clinical immunology. In practice (J Allergy Clin Immunol Pract) Vol. 9 Issue 7 Pg. 2725-2731 (07 2021) ISSN: 2213-2201 [Electronic] United States
• PMID: 33549843 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2021 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Adrenal Cortex Hormones
• Anti-Asthmatic Agents

Topics

• Adrenal Cortex Hormones (therapeutic use)
• Anti-Asthmatic Agents (therapeutic use)
• Asthma (diagnosis, drug therapy)
• Biological Therapy
• Forced Expiratory Volume
• Humans