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Clinical Recommendations for the Management of Biological Treatments in Severe Asthma Patients: A Consensus Statement

Delgado J1, Dávila IJ2, Domínguez-Ortega J3 on behalf of the Severe Asthma Group (SEAIC)

1Allergology Clinical Management Unit, Virgen Macarena Hospital, Seville, Spain; SEAIC Asthma Committee
2Allergy Service, University Hospital, Salamanca; Associate Professor, Department of Biomedical and Diagnostics Science, School of Medicine, Salamanca; SEAIC Asthma Committee
3Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain; CIBER de Enfermedades Respiratorias (CIBERES); SEAIC Asthma Committee

J Investig Allergol Clin Immunol 2021; Vol 31(1) : 36-43
doi: 10.18176/jiaci.0638

Background: The definition of severe uncontrolled asthma and the best phenotype-driven management are not fully established.
Objective: We aimed to reach a consensus on the definition of severe uncontrolled asthma and give recommendations on optimal management with phenotype-targeted biological therapies.
Methods: A modified Delphi technique was used. A scientific committee provided statements addressing the definition of severe uncontrolled asthma and controversial issues about its treatment with biologics. The questionnaire was evaluated in 2 rounds by expert allergists. With the results, the scientific committee developed recommendations and a practical algorithm.
Results: A panel of 27 allergists reached agreement on 27 out of the 29 items provided (93.1%). A consensus definition of severe uncontrolled asthma was agreed. Prior to initiation of therapy, it is mandatory to establish the asthma phenotype and assess the presence of clinically important allergic sensitizations. Anti-IgE, anti–IL-5, anti–IL-5 receptor, and anti–IL-13/IL-4 receptor inhibitors are suitable options for patients with allergic asthma and a blood eosinophil level >300/μL (>150/μL in patients receiving oral corticosteroids). IL-5 and anti–IL-5 receptor inhibitors are recommended for patients with an eosinophilic phenotype and can also be used for patients with severe eosinophilic allergic asthma with no or a suboptimal response to omalizumab. Dupilumab is recommended for patients with moderate-severe asthma and a TH2-high phenotype. Only physicians with experience in the treatment of severe uncontrolled asthma should initiate biological treatment.
Conclusion: We provide consensus clinical recommendations that may be useful in the management of patients with severe uncontrolled asthma.

Key words: Asthma, Delphi technique, Consensus, Biological therapy, Monoclonal antibodies, Algorithms

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