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Criteria to evaluate efficacy of biologics in asthma: a Global Asthma Association survey
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  • Angelica Tiotiu,
  • Andras Bikov,
  • Francisco-Javier Gonzalez-Barcala,
  • Silviya Novakova,
  • Plamena Novakova,
  • Herberto Chong-Neto,
  • Pierachille Santus,
  • Ignacio J Ansotegui,
  • Juan Carlos Ivancevich,
  • Krzysztof Kowal,
  • Stefan Mihaicuta,
  • Denislava Nedeva,
  • Giorgio Walter Canonica,
  • Jonathan Bernstein,
  • Louis-Philippe Boulet,
  • Fulvio Braido
Angelica Tiotiu
Centre hospitalier regional universitaire de Nancy

Corresponding Author:[email protected]

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Andras Bikov
Wythenshawe Hospital
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Francisco-Javier Gonzalez-Barcala
Complejo Hospitalario Universitario de Santiago de Compostela
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Silviya Novakova
UMBAL Sveti Georgi
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Plamena Novakova
Medicinski universitet-Sofia
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Herberto Chong-Neto
Universidade Federal do Parana Hospital de Clinicas
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Pierachille Santus
Universita degli Studi di Milano Dipartimento di Scienze Biomediche e Cliniche Luigi Sacco
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Ignacio J Ansotegui
Hospital Quirónsalud Bizkaia
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Juan Carlos Ivancevich
Clínica Santa Isabel
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Krzysztof Kowal
Medical University of Bialystok
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Stefan Mihaicuta
Center for Research and Innovation in Precision Medicine and Pharmacy
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Denislava Nedeva
Medicinski universitet-Sofia
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Giorgio Walter Canonica
Humanitas University
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Jonathan Bernstein
University of Cincinnati Department of Internal Medicine
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Louis-Philippe Boulet
Institut universitaire de cardiologie et de pneumologie de Quebec
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Fulvio Braido
University of Genoa
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Background: Several biologics are now available as add-on treatment for severe asthma but, currently there are no universally accepted criteria to measure the response to these therapies. This survey aims to establish consensus criteria to use in practice for the initial evaluation of response to biologics after four months of treatment. Method: Using Delphi methodology, a questionnaire including ten items was developed and validated by a 13-member panel of international experts in asthma. The electronic survey circulated within the INterasma Scientific Network platform, Global Asthma Association membership, contact list of the co-authors, national associations for specialists, and social media. 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 accorded “high importance” and “very high importance”. All selected criteria were validated by the thirteen experts. Results: Four criteria were identified to evaluate the efficacy of biologics in asthma: to reduce daily systemic corticosteroids dose by ≥50% (ideally complete withdrawal); to decrease the number of asthma exacerbations requiring systemic corticosteroids by ≥50%, (ideally no asthma exacerbation); to have no/minimal side-effects and to obtain asthma control according validated questionnaires. The consensual decision was that ≥3 criteria are needed to conclude 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.