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Efficacy and safety of treatment with dupilumab for severe asthma: A systematic review for the EAACI Guidelines - recommendations on the use of biologicals in severe asthma

Research output: Contribution to journalArticle

  • Ioana Agache
  • Yang Song
  • Claudio Rocha
  • Jessica Beltran
  • Margarita Posso
  • Ivan Sola
  • Corinna Steiner
  • Pablo Alonso‐coello
  • Cezmi A Akdis
  • Mubeccel Akdis
  • Walter Canonica
  • Thomas Casale
  • Thomas Chivato
  • Jonathan Corren
  • Stefano Del Giacco
  • Thomas Eiwegger
  • Davide Firinu
  • James E. Gern
  • Eckard Hamelmann
  • Nicola A Hanania
  • Mika Makela
  • Irene Hernández Martín
  • Parameswaran Nair
  • Liam O'Mahony
  • Nikolas G. Papadopoulos
  • Alberto Papi
  • Hae-Sim Park
  • Luis Pérez De Llano
  • Santiago Quirce
  • Joaquin Sastre
  • Mohamed H Shamji
  • Carlos Canelo‐aybar
  • Oscar Palomares
  • Marek Jutel

Related Edinburgh Organisations

Original languageEnglish
Early online date10 Mar 2020
Publication statusE-pub ahead of print - 10 Mar 2020


Dupilumab, a fully human monoclonal antibody against Interleukin-4 receptor α is approved as add-on maintenance treatment for inadequately controlled type 2 severe asthma. This systematic review evaluates the effectiveness, safety and economic impact of dupilumab compared to standard of care for uncontrolled severe asthma.Pubmed, EMBASE and Cochrane Library were searched for RCTs and health economic evaluations. Critical and important asthma-related outcomes were evaluated. The risk of bias and the certainty of the evidence were assessed using GRADE.Three RCTs including 2735 subjects > 12 years old and 24 to 52 weeks of follow-up were included. Dupilumab reduced with high certainty severe asthma exacerbations (RR 0.51; 95%CI 0.45 to 0.59) and oral corticosteroid use (mean difference (MD) -28.2 mg/day; 95% CI -40.7 to -15.7). Asthma control (ACQ-5), quality of life (AQLQ) and rescue medication use [puffs/day] improved, without reaching the minimal important clinical difference: ACQ-5 MD -0.28 (95%CI -0.39 to -0.17); AQLQ MD +0.28 (95% CI 0.20 - 0.37); rescue medication MD -0.35 (95%CI -0.73 to +0.02). FEV1 increases (MD +0.15; 95% CI +0.11 to +0.18) (moderate certainty). There is increased rate of dupilumab-related adverse events (AEs) (moderate certainty) and of drug-related serious AEs (low certainty). The incremental cost-effectiveness ratio versus standard therapy was 464,000 $/QALY (moderate certainty).More data on long term safety are needed both for children and adults, together with more efficacy data in the paediatric population.

ID: 137625333