Efficacy and safety of treatment with biologicals for severe chronic rhinosinusitis with nasal polyps: A systematic review for the EAACI guidelines

Ioana Agache; Yang Song; Pablo Alonso-Coello; Yasmin Vogel; Claudio Rocha; Ivan Solà; Marilina Santero; Cezmi A Akdis; Mubeccel Akdis; Giorgio Walter Canonica; Tomas Chivato; Stefano Del Giacco; Thomas Eiwegger; Wytske Fokkens; Christos Georgalas; Philippe Gevaert; Claire Hopkins; Ludger Klimek; Valerie Lund; Robert Naclerio; Liam O'Mahony; Susanna Palkonen; Oliver Pfaar; Jürgen Schwarze; Michael B Soyka; De Yun Wang; Luo Zhang; Carlos Canelo-Aybar; Oscar Palomares; Marek Jutel

doi:10.1111/all.14809

Efficacy and safety of treatment with biologicals for severe chronic rhinosinusitis with nasal polyps: A systematic review for the EAACI guidelines

Allergy. 2021 Aug;76(8):2337-2353. doi: 10.1111/all.14809. Epub 2021 Mar 24.

Authors

Ioana Agache¹, Yang Song², Pablo Alonso-Coello^{2

3}, Yasmin Vogel⁴, Claudio Rocha², Ivan Solà², Marilina Santero², Cezmi A Akdis^{5

6}, Mubeccel Akdis⁵, Giorgio Walter Canonica⁷, Tomas Chivato⁸, Stefano Del Giacco⁹, Thomas Eiwegger^{10

11

12}, Wytske Fokkens¹³, Christos Georgalas¹⁴, Philippe Gevaert¹⁵, Claire Hopkins¹⁶, Ludger Klimek¹⁷, Valerie Lund¹⁸, Robert Naclerio¹⁹, Liam O'Mahony²⁰, Susanna Palkonen²¹, Oliver Pfaar²², Jürgen Schwarze²³, Michael B Soyka²⁴, De Yun Wang²⁵, Luo Zhang^{26

27

28}, Carlos Canelo-Aybar^{2

3}, Oscar Palomares²⁹, Marek Jutel^{30

31}

Affiliations

¹ Transylvania University Brasov, Brasov, Romania.
² Department of Clinical Epidemiology and Public Health, Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain.
³ CIBER de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.
⁴ Furtwangen University, Furtwangen im Schwarzwald, Germany.
⁵ Swiss Institute of Allergy and Asthma Research (SIAF), University of Zurich, Davos, Switzerland.
⁶ Christine Kühne-Center for Allergy Research and Education, Davos, Switzerland.
⁷ Personalized Medicine Asthma & Allergy Clinic, IRCCS Research Hospital, Humanitas University, Milan, Italy.
⁸ School of Medicine, University CEU San Pablo, Madrid, Spain.
⁹ Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.
¹⁰ Translational Medicine Program, Research Institute, Hospital for Sick Children, Toronto, ON, Canada.
¹¹ Department of Immunology, University of Toronto, Toronto, ON, Canada.
¹² Division of Immunology and Allergy, Food Allergy and Anaphylaxis Program, Departments of Paediatrics and Immunology, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
¹³ Department of Otorhinolaryngology, Academic Medical Center (AMC), University of Amsterdam, Amsterdam, The Netherlands.
¹⁴ Medical School, University of Nicosia, Nicosia, Cyprus.
¹⁵ Department of Otorhinolaryngology, Upper Airway Research Laboratory (URL), Ghent University Hospital, Ghent, Belgium.
¹⁶ Department of ENT, Guy's Hospital, London, UK.
¹⁷ Zentrum für Rhinologie und Allergologie, Wiesbaden, Germany.
¹⁸ Royal National Throat, Nose and Ear Hospital, UCLH, London, UK.
¹⁹ Department of Otolaryngology - Head and Neck Surgery, Johns Hopkins University, Baltimore, MD, USA.
²⁰ Departments of Medicine and Microbiology, APC Microbiome Ireland, University College Cork, Cork, Ireland.
²¹ European Federation of Allergy and Airways Diseases Patients' Associations (EFA), Brussels, Belgium.
²² Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.
²³ Centre for Inflammation Research, Child Life and Health, The University of Edinburgh, Edinburgh, UK.
²⁴ Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
²⁵ Department of Otolaryngology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
²⁶ Department of Otolaryngology-Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China.
²⁷ Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China.
²⁸ Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, China.
²⁹ Department of Biochemistry and Molecular Biology, Chemistry School, Complutense University of Madrid, Madrid, Spain.
³⁰ Department of Clinical Immunology, University of Wroclaw, Wroclaw, Poland.
³¹ "ALL-MED" Medical Research Institute, Wroclaw, Poland.

PMID: 33683704
DOI: 10.1111/all.14809

Abstract

This systematic review evaluates the efficacy and safety of biologicals for chronic rhinosinusitis with nasal polyps (CRSwNP) compared with the standard of care. PubMed, Embase, and Cochrane Library were searched for RCTs. Critical and important CRSwNP-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE. RCTs evaluated (dupilumab-2, omalizumab-4, mepolizumab-2, and reslizumab-1) included 1236 adults, with follow-up of 20-64 weeks. Dupilumab reduces the need for surgery (NFS) or oral corticosteroid (OCS) use (RR 0.28; 95% CI 0.20-0.39, moderate certainty) and improves with high certainty smell evaluated with UPSIT score (mean difference (MD) +10.54; 95% CI +9.24 to +11.84) and quality of life (QoL) evaluated with SNOT-22 (MD -19.14; 95% CI -22.80 to -15.47), with fewer treatment-related adverse events (TAEs) (RR 0.95; 95% CI 0.89-1.02, moderate certainty). Omalizumab reduces NFS (RR 0.85; 95% CI 0.78-0.92, high certainty), decreases OCS use (RR 0.38; 95% CI 0.10-1.38, moderate certainty), and improves high certainty smell (MD +3.84; 95% CI +3.64 to +4.04) and QoL (MD -15.65; 95% CI -16.16 to -15.13), with increased TAE (RR 1.73; 95% CI 0.60-5.03, moderate certainty). There is low certainty for mepolizumab reducing NFS (RR 0.78; 95% CI 0.64-0.94) and improving QoL (MD -13.3; 95% CI -23.93 to -2.67) and smell (MD +0.7; 95% CI -0.48 to +1.88), with increased TAEs (RR 1.64; 95% CI 0.41-6.50). The evidence for reslizumab is very uncertain.

Keywords: chronic rhinosinusitis; dupilumab; mepolizumab; omalizumab; reslizumab.

Publication types

Systematic Review

MeSH terms

Adult
Biological Products* / adverse effects
Humans
Nasal Polyps* / drug therapy
Omalizumab / adverse effects
Quality of Life
Sinusitis* / drug therapy

Substances

Biological Products
Omalizumab