Efficacy and safety of treatment with biologicals (benralizumab, dupilumab and omalizumab) for severe allergic asthma: A systematic review for the EAACI Guidelines - recommendations on the use of biologicals in severe asthma
Por:
Agache, I, Rocha, C, Beltran, J, Song, Y, Posso, M, Sola, I, Alonso-Coello, P, Akdis, C, Akdis, M, Canonica, GW, Casale, T, Chivato, T, Corren, J, Del Giacco, S, Eiwegger, T, Firinu, D, Gern, JE, Hamelmann, E, Hanania, N, Makela, M, Martin, IH, Nair, P, O'Mahony, L, Papadopoulos, NG, Papi, A, Park, HS, de Llano, LP, Quirce, S, Sastre, J, Shamji, M, Schwarze, J, Canelo-Aybar, C, Palomares, O, Jutel, M
Publicada:
1 may 2020
Resumen:
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) vs 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 annualized 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); and 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 annualized 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)].
Filiaciones:
Agache, I:
Transylvania Univ, Fac Med, 2A Pictor Ion Andreescu, Brasov 500051, Romania
Rocha, C:
Biomed Res Inst St Pau IIB St Pau, Iberoamer Cochrane Ctr, Dept Clin Epidemiol & Publ Hlth, Barcelona, Spain
Beltran, J:
Biomed Res Inst St Pau IIB St Pau, Iberoamer Cochrane Ctr, Dept Clin Epidemiol & Publ Hlth, Barcelona, Spain
Song, Y:
Biomed Res Inst St Pau IIB St Pau, Iberoamer Cochrane Ctr, Dept Clin Epidemiol & Publ Hlth, Barcelona, Spain
Posso, M:
Biomed Res Inst St Pau IIB St Pau, Iberoamer Cochrane Ctr, Dept Clin Epidemiol & Publ Hlth, Barcelona, Spain
IMIM Hosp del Mar Med Res Inst, Dept Epidemiol & Evaluat, Barcelona, Spain
Sola, I:
Biomed Res Inst St Pau IIB St Pau, Iberoamer Cochrane Ctr, Dept Clin Epidemiol & Publ Hlth, Barcelona, Spain
Alonso-Coello, P:
Biomed Res Inst St Pau IIB St Pau, Iberoamer Cochrane Ctr, Dept Clin Epidemiol & Publ Hlth, Barcelona, Spain
CIBER Epidemiol & Salud Publ CIBERESP, Barcelona, Spain
Akdis, C:
Univ Zurich, Swiss Inst Allergy & Asthma Res SIAF, Davos, Switzerland
Akdis, M:
Univ Zurich, Swiss Inst Allergy & Asthma Res SIAF, Davos, Switzerland
Canonica, GW:
IRCCS, Personalized Med Asthma & Allergy Humanitas Clin, Rozzano, Italy
Casale, T:
Univ S Florida, Morsani Coll Med, Div Allergy & Immunol, Tampa, FL 33620 USA
Chivato, T:
Univ CEU San Pablo, Sch Med, Madrid, Spain
Corren, J:
Univ Calif Los Angeles, David Geffen Sch Med, Los Angeles, CA 90095 USA
Del Giacco, S:
Univ Cagliari, Dept Med Sci & Publ Hlth, Monserrato, Italy
Eiwegger, T:
Hosp Sick Children, Res Inst, Translat Med Program, Toronto, ON, Canada
Univ Toronto, Dept Immunol, Toronto, ON, Canada
Univ Toronto, Food Allergy & Anaphylaxis Program, Div Immunol & Allergy, Dept Paediat,Hosp Sick Children, Toronto, ON, Canada
Univ Toronto, Food Allergy & Anaphylaxis Program, Div Immunol & Allergy, Hosp Sick Children,Dept Immunol, Toronto, ON, Canada
Firinu, D:
Univ Cagliari, Dept Med Sci & Publ Hlth, Monserrato, Italy
Gern, JE:
Univ Wisconsin, Dept Pediat, Sch Med & Publ Hlth, Madison, WI USA
Hamelmann, E:
Kinderzentrum Bethel, Klin Kinder & Jugendmed, Bielefeld, Germany
Hanania, N:
Baylor Coll Med, Sect Pulm Crit Care & Sleep Med, Houston, TX 77030 USA
Makela, M:
Helsinki Univ Hosp, Skin & Allergy Hosp, Helsinki, Finland
Univ Helsinki, Helsinki, Finland
Martin, IH:
Hosp Univ La Paz, Dept Allergy, Madrid, Spain
Nair, P:
McMaster Univ, Dept Med, Div Respirol, Hamilton, ON, Canada
St Josephs Healthcare, Firestone Inst Resp Hlth, Hamilton, ON, Canada
O'Mahony, L:
Univ Coll Cork, APC Microbiome Ireland, Dept Med, Cork, Ireland
Univ Coll Cork, APC Microbiome Ireland, Dept Microbiol, Cork, Ireland
Papadopoulos, NG:
Univ Manchester, Div Infect Immun & Resp Med, Manchester, Lancs, England
Natl Kapodistrian Univ Athens, Allergy Dept, Pediat Clin 2, Athens, Greece
Papi, A:
Univ Ferrara, Res Ctr Asthma & COPD, Dept Med Sci, Ferrara, Italy
Park, HS:
Ajou Univ, Dept Allergy & Clin Immunol, Suwon, South Korea
de Llano, LP:
Hosp Lucus Augusti, Dept Resp Med, Lugo, Spain
Quirce, S:
Univ Autonoma Madrid, La Paz Univ Hosp, CIBER Resp Dis CIBERES, IdiPAZ,Dept Allergy, Madrid, Spain
Sastre, J:
Univ Autonoma Madrid, Fac Med, Madrid, Spain
Shamji, M:
Natl Heart & Lung Inst, Immunomodulat & Tolerance Grp, Allergy & Clin Immunol, Inflammat,Repair,Dev, London, England
UK Ctr Allerg Mech Asthma, Imperial Coll NIHR Biomed Res Ctr, London, England
Schwarze, J:
Univ Edinburgh, Ctr Inflammat Res Child Life & Hlth, Edinburgh, Midlothian, Scotland
Canelo-Aybar, C:
Biomed Res Inst St Pau IIB St Pau, Iberoamer Cochrane Ctr, Dept Clin Epidemiol & Publ Hlth, Barcelona, Spain
Univ Zurich, Swiss Inst Allergy & Asthma Res SIAF, Davos, Switzerland
Palomares, O:
Univ Complutense Madrid, Chem Sch, Dept Biochem & Mol Biol, Madrid, Spain
Jutel, M:
Univ Wroclaw, Dept Clin Immunol, Wroclaw, Poland
ALL MED Med Res Inst, Wroclaw, Poland
Green Published, Bronze
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