Efficacy and safety of treatment with biologicals (benralizumab, dupilumab and omalizumab) for severe allergic asthma

Ioana Agache, Claudio Rocha, Jessica Beltran, Yang Song, Margarita Posso, Ivan Solà, Pablo Alonso‐coello, Cezmi Akdis, Mubeccel Akdis, Walter Canonica, Thomas Casale, Tomas Chivato, Jonathan Corren, Stefano Del Giacco, Thomas Eiwegger, Davide Firinu, James E. Gern, Eckard Hamelmann, Nicola Hanania, Mika MäkeläIrene Hernández Martín, Parameswaran Nair, Liam O’mahony, Nikolaos G. Papadopoulos, Alberto Papi, Hae‐sim Park, Luis Pérez De Llano, Santiago Quirce, Joaquin Sastre, Mohamed Shamji, Jurgen Schwarze, Carlos Canelo‐aybar, Oscar Palomares, Marek Jutel

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

Allergic asthma is a frequent asthma phenotype. Both IgE and type 2 cytokines are increased, with some degree of overlap with other phenotypes.

Systematic reviews assessed the efficacy and safety of benralizumab, dupilumab and omalizumab (alphabetical order) versus standard of care for patients with uncontrolled severe allergic asthma. Pubmed, EMBASE and Cochrane Library were searched to identify RCTs and health economic evaluations, published in English. Critical and important asthma‐related outcomes were evaluated. The risk of bias and the certainty of the evidence were assessed using GRADE.

All three biologicals reduced with high certainty the annualised asthma exacerbation rate: benralizumab incidence rate ratios (IRR) 0.63 (95% CI 0.50−0.81); dupilumab IRR 0.58 (95%CI 0.47−0.73); omalizumab IRR 0.56 (95%CI 0.42−0.73). Benralizumab and dupilumab improved asthma control with high certainty and omalizumab with moderate certainty, however none reached the minimal important difference (MID). Both benralizumab and omalizumab improved QoL with high certainty, but only omalizumab reached the MID. Omalizumab enabled ICS dose reduction with high certainty. Benralizumab and omalizumab showed an increase in drug‐related adverse events (AEs) with low to moderate certainty. All three biologicals had moderate certainty for an ICER/QALY value above the willingness to pay threshold. There was high certainty that in children 6‐12 years old omalizumab decreased the annualised exacerbation rate [IRR 0.57 (95%CI 0.45‐0.72)], improved QoL [relative risk 1.43 (95%CI 1.12 ‐1.83)], reduced ICS [mean difference (MD) ‐0.45 (95% CI ‐0.58 to ‐0.32)] and rescue medication use [ MD ‐0.41 (95%CI ‐0.66 to ‐0.15)].
Original languageEnglish
Publication statusPublished - 16 Feb 2020


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