Andrew Thamboo1, S Kilty2, I Witterick3, Y Chan3, C J Chin4, A Janjua5, A Javer5, J Lee3, E Monterio3, B Rotenberg6, J Scott4, K Smith7, D D Sommer8, L Sowerby6, M Tewfik9, E Wright10, M Desrosiers11. 1. Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of British Columbia, 2600-1081 Burrard Street, Vancouver, British Columbia, V6Z 1Y6, Canada. andrew.thamboo@gmail.com. 2. Department of Otolaryngology-Head and Neck Surgery, The University of Ottawa and The Ottawa Hospital, Ottawa, ON, Canada. 3. Department of Otolaryngology-Head & Neck Surgery, University of Toronto, Toronto, ON, Canada. 4. Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, Dalhousie University, Halifax, NS, Canada. 5. Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of British Columbia, 2600-1081 Burrard Street, Vancouver, British Columbia, V6Z 1Y6, Canada. 6. Department of Otolaryngology-Head and Neck Surgery, Western University, London, ON, Canada. 7. Department of Otolaryngology-Head and Neck Surgery, University of Manitoba, Winnipeg, MB, Canada. 8. Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada. 9. Department of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, QC, Canada. 10. Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Alberta, Edmonton, AB, Canada. 11. Division of Otolaryngology-Head and Neck Surgery, Centre Hospitalier de l'University de Montreal, Montreal, QC, Canada.
Abstract
BACKGROUND: Recent evidence suggests that biologic therapy with targeted activity within the Type 2 inflammatory pathway can improve the clinical signs and symptoms of chronic rhinosinusitis with nasal polyposis (CRSwNP). There remains a population in CRSwNP that despite medical therapy and endoscopic sinus surgery have persistent signs and symptoms of disease. Therefore, biologics, monoclonal antibody agents, could be beneficial therapeutic treatments for these patients. There have been eight randomized, double-blind, placebo-controlled trails performed for CRSwNP targeted components of the Type 2 inflammatory pathway, notably interleukin (IL)-4, IL-5 and IL-13, IL-5R, IL-33, and immunoglobulin (Ig)E. However, there are no formal recommendations for the optimal use of biologics in managing Chronic Rhinosinusitis (CRS) within the Canadian health care environment. METHODS: A Delphi Method process was utilized involving three rounds of questionnaires in which the first two were completed individually online and the third was discussed on a virtual platform with all the panelists. 17 fellowship trained rhinologists across Canada evaluated the 28 original statements on a scale of 1-10 and provided comments. A rating within 1-3 indicated disagreement, 8-10 demonstrated agreement and 4-7 represented being neutral towards a statement. All ratings were quantitively reviewed by mean, median, mode, range and standard deviation. Consensus was defined by removing the highest and lowest of the scores and using the "3 point relaxed system". RESULTS: After three rounds, a total of 11 statements achieved consensus. This white paper only contains the final agreed upon statements and clear rationale and support for the statements regarding the use of biologics in patients with CRS. CONCLUSION: This white paper provides guidance to Canadian physicians on the use of biologic therapy for the management of patients with CRS, but the medical and surgical regimen should ultimately be individualized to the patient. As more biologics become available and additional trials are published we will provide updated versions of this white paper every few years.
RCT Entities:
BACKGROUND: Recent evidence suggests that biologic therapy with targeted activity within the Type 2 inflammatory pathway can improve the clinical signs and symptoms of chronic rhinosinusitis with nasal polyposis (CRSwNP). There remains a population in CRSwNP that despite medical therapy and endoscopic sinus surgery have persistent signs and symptoms of disease. Therefore, biologics, monoclonal antibody agents, could be beneficial therapeutic treatments for these patients. There have been eight randomized, double-blind, placebo-controlled trails performed for CRSwNP targeted components of the Type 2 inflammatory pathway, notably interleukin (IL)-4, IL-5 and IL-13, IL-5R, IL-33, and immunoglobulin (Ig)E. However, there are no formal recommendations for the optimal use of biologics in managing Chronic Rhinosinusitis (CRS) within the Canadian health care environment. METHODS: A Delphi Method process was utilized involving three rounds of questionnaires in which the first two were completed individually online and the third was discussed on a virtual platform with all the panelists. 17 fellowship trained rhinologists across Canada evaluated the 28 original statements on a scale of 1-10 and provided comments. A rating within 1-3 indicated disagreement, 8-10 demonstrated agreement and 4-7 represented being neutral towards a statement. All ratings were quantitively reviewed by mean, median, mode, range and standard deviation. Consensus was defined by removing the highest and lowest of the scores and using the "3 point relaxed system". RESULTS: After three rounds, a total of 11 statements achieved consensus. This white paper only contains the final agreed upon statements and clear rationale and support for the statements regarding the use of biologics in patients with CRS. CONCLUSION: This white paper provides guidance to Canadian physicians on the use of biologic therapy for the management of patients with CRS, but the medical and surgical regimen should ultimately be individualized to the patient. As more biologics become available and additional trials are published we will provide updated versions of this white paper every few years.
Entities:
Keywords:
Biologics; Chronic Rhinosinusitis; Chronic rhinosinusitis with nasal polyposis; Type 2 inflammation
Authors: Claus Bachert; S James Zinreich; Peter W Hellings; Joaquim Mullol; Daniel L Hamilos; Philippe Gevaert; Robert M Naclerio; Nikhil Amin; Vijay N Joish; Chunpeng Fan; Donghui Zhang; Heribert Staudinger; Gianluca Pirozzi; Neil M H Graham; Asif Khan; Leda P Mannent Journal: Rhinology Date: 2020-02-01 Impact factor: 3.681