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

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.

KEYWORDS:

• asthma
• biologics
• criteria
• efficacy
• survey

Acknowledgments

The authors thank all the participants in this survey. A Bikov was supported by NIHR Manchester BRC for Figure 5.

Declaration of interest

A Tiotiu reports honoraria for lectures, presentations, speakers bureaus, and educational events from ALK, AstraZeneca, Chiesi, GSK, Novartis, Sanofi; support for attending meetings and/or travel from AstraZeneca, Sanofi; participation on Advisory Board for Sanofi.

FJ Gonzalez-Barcala reports grants or contracts from GSK, consulting fees from ALK, Astra-Zeneca, Bial, Chiesi, Gebro Pharma, GlaxoSmithKline, Menarini, Novartis, Rovi, Roxall, Sanofi, Stallergenes-Greer, and Teva; honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from ALK, Astra-Zeneca, Bial, Chiesi, Gebro Pharma, GlaxoSmithKline, Menarini, Novartis, Rovi, Roxall, Sanofi, Stallergenes-Greer, and Teva; support for attending meetings and/or travel from ALK, Menarini, and Sanofi; participation on a Data Safety Monitoring Board or Advisory Board for ALK, Astra-Zeneca, GlaxoSmithKline, Menarini, Novartis, Sanofi, and Teva.

JCI reports consulting fees from Faes Farma, Laboratorio Casasco; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Faes Farma, Laboratorio Casasco, Abbott Ecuador, and Bago Bolivia.

K Kowal reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from ALK Abello, Astra Zeneca, Chiesi, HAL Allergy, Orion Pharma, Stallergenes, TEVA, and support for attending meetings and/or travel from Berlin Chemie.

D Nedeva reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Astra Zeneca, Berlin Chemie, Takeda, Chiesi, and Sanofi; support for attending meetings and/or travel from Chiesi andAstra Zeneca.

FB reports grants or contracts from any entity from GS, Chiesi, and Vitalaire; consulting fees from AZ, GS, Chiesi, and Menarini; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Menarini group, AZ, GSK, Chiesi, and Novartis; leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: President of Interasma.

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Author contributions

A Tiotiu, FJ Gonzalez-Barcala, S Novakova, P Novakova, H Chong-Neto, JC Ivancevich, K Kowal, S Mihaicuta, D Nedeva, GW Canonica, J Bernstein, LP Boulet, and F Braido compose the 13 expert panel and had substantial contributions to the conception of the work; A Tiotiu, A Bikov, P Santus, and I Ansotegui contributed to the statistical analysis; A Tiotiu, LP Boulet, and F Braido wrote the paper; all the authors read the manuscript, contributed to improve the draft, agreed for all aspects of the work, and approved the manuscript for the submission.

Additional information

Funding

This paper was not funded.