Clinical Research Needs for the Management of Chronic Rhinosinusitis with Nasal Polyps in the New Era of Biologics: A National Institute of Allergy and Infectious Diseases Workshop

Robert Naclerio; Fuad Baroody; Claus Bachert; Benjamin Bleier; Larry Borish; Erica Brittain; Geoffrey Chupp; Anat Fisher; Wytske Fokkens; Philippe Gevaert; David Kennedy; Jean Kim; Tanya M. Laidlaw; Jake J. Lee; Jay F. Piccirillo; Jayant M. Pinto; Lauren T. Roland; Robert P. Schleimer; Rodney J. Schlosser; Julie M. Schwaninger; Timothy L. Smith; Bruce K. Tan; Ming Tan; Elina Toskala; Sally Wenzel; Alkis Togias

doi:10.1016/j.jaip.2020.02.023

Clinical Research Needs for the Management of Chronic Rhinosinusitis with Nasal Polyps in the New Era of Biologics: A National Institute of Allergy and Infectious Diseases Workshop

Robert Naclerio, Fuad Baroody, Claus Bachert, Benjamin Bleier, Larry Borish, Erica Brittain, Geoffrey Chupp, Anat Fisher, Wytske Fokkens, Philippe Gevaert, David Kennedy, Jean Kim, Tanya M. Laidlaw, Jake J. Lee, Jay F. Piccirillo, Jayant M. Pinto, Lauren T. Roland, Robert P. Schleimer, Rodney J. Schlosser, Julie M. SchwaningerTimothy L. Smith, Bruce K. Tan, Ming Tan, Elina Toskala, Sally Wenzel, Alkis Togias^*

^*Corresponding author for this work

Research output: Contribution to journal › Review article › peer-review

47 Scopus citations

Abstract

The development of biologics targeting various aspects of type 2 inflammation for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) will provide clinicians with powerful tools to help treat these patients. However, other therapies are also available, and positioning of biologics in a management algorithm will require comparative trials. In November 2019, the National Institute of Allergy and Infectious Diseases convened a workshop to consider potential future trial designs. Workshop participants represented a wide spectrum of clinical specialties, including otolaryngology, allergy, and pulmonary medicine, as well as expertise in CRSwNP pathophysiology and in trial methodology and statistics. The workshop discussed the current state of knowledge in CRSwNP and considered the advantages and disadvantages of various clinical trial or observational study designs and various clinical outcomes. The output from this workshop, which is presented in this report, will hopefully provide investigators with adequate information and ideas to design future studies and answer critical clinical questions. It will also help clinicians understand the current state of the management of CRSwNP and its gaps and be more able to interpret the new information to come.

Original language	English (US)
Pages (from-to)	1532-1549.e1
Journal	Journal of Allergy and Clinical Immunology: In Practice
Volume	8
Issue number	5
DOIs	https://doi.org/10.1016/j.jaip.2020.02.023
State	Published - May 2020

Funding

Conflicts of interest: R. Naclerio reports serving as an advisory board member and/or speaker for AstraZeneca, GlaxoSmithKline (GSK), Sanofi, and Regeneron; consulting for the American Chemistry Council and Lyra Therapeutics; serving on the speaker bureau of Optinose; and providing expert witness testimony in the last year. F. Baroody reports serving on advisory boards for ALK, AstraZeneca, and Regeneron. C. Bachert reports serving as a consultant/speaker for Sanofi, Novartis, AstraZeneca, GSK, Stallergenes, ALK, and Meda. B. Bleier reports consulting for Olympus, Karl Storz, Medtronic, Sinopsys, Baxter, and 3D Matrix; owning stock/equity in Thieme; patent licensing arrangements with Massachusetts Eye and Ear; and receiving research support from the National Institutes of Health (NIH). L. Borish reports consulting for Sanofi-Aventis and receiving research support from Regeneron, GSK, and the NIH. G. Chupp reports serving as a board member, speakers bureau member (advisory), and being a clinical trial principal investigator for AstraZeneca, Genentech, GSK, Circassia, Sanofi-Genzyme, Regeneron, Boehringer Ingelheim, and Boston Scientific. W. Fokkens reports consulting/speaking arrangements with Sanofi and Lyra Therapeutics and receiving research support from GSK, Sanofi, Novartis Chordate, Mylan, ALK, and Allergy diagnostics. P. Gevaert reports consulting for Sanofi, Regeneron, Novartis, Roche, Genentech, AstraZeneca, and 3NT and receiving research support from Argenx and 3NT. D. Kennedy reports consulting for GSK, Intersect ENT, Medtronic, and Neurent; serving on the advisory board of Sinuwave; and patent licensing arrangements with Medtronic Xomed. J. Kim reports consulting for Genentech. T. M. Laidlaw reports consulting for GSK and Regeneron. J. F. Piccirillo reports patent licensing arrangements with the Washington University School of Medicine for a Sino-Nasal Outcome test. J. M. Pinto reports consulting/speaker arrangements with Sanofi, Regeneron, ALK, Genentech, and Stallergenes Greer; owning stock/equity in Om Probiotics; and research support from the NIH. L. T. Roland reports serving as a consultant for Tissium. R. P. Schleimer reports serving as a consultant for Intersect ENT, GSK, Allakos, Aurasense, Merck, BioMarck, Sanofi, AstraZeneca/MedImmune, Genentech, Exicure, Otsuka, Aqualung Therapeutics Corp, Actobio Therapeutics, Lyra Therapeutics, Astellas Pharm Inc, Genzyme/Sanofi Corp, and Celgene Corp; owning stock/equity in Allakos, Aurasense, BioMarck, Exicure, and Aqualung Therapeutics Corp; patent licensing arrangements with Allakos; and receiving research support from the NIH. R. J. Schlosser reports consulting and/or speaker arrangements with Stryker, Olympus, Optinose, GSK, Regeneron, and Roche; owning stock/equity in Healthy Humming; and receiving research support from Gossamer, Stryker, Optinose, GSK, AstraZeneca, Regeneron, Roche, and Healthy Humming. T. L. Smith reports receiving research support from the NIH. B. K. Tan reports serving on the advisory board of Sanofi-Genzyme and Optinose and owning stock in Allakos. E. Toskala reports consulting for Fiagan, serving on the advisory board of Optinose, and receiving research support from Sanofi. S. Wenzel reports consulting for Sanofi-Aventis, GSK, AstraZeneca, and Pieris and receiving research support from AstraZeneca, Novartis, Sanofi, and Knopp Pharmaceuticals. The rest of the authors declare that they have no relevant conflicts of interest. Conflicts of interest: R. Naclerio reports serving as an advisory board member and/or speaker for AstraZeneca, GlaxoSmithKline (GSK), Sanofi, and Regeneron; consulting for the American Chemistry Council and Lyra Therapeutics; serving on the speaker bureau of Optinose; and providing expert witness testimony in the last year. F. Baroody reports serving on advisory boards for ALK, AstraZeneca, and Regeneron. C. Bachert reports serving as a consultant/speaker for Sanofi, Novartis, AstraZeneca, GSK, Stallergenes, ALK, and Meda. B. Bleier reports consulting for Olympus, Karl Storz, Medtronic, Sinopsys, Baxter, and 3D Matrix; owning stock/equity in Thieme; patent licensing arrangements with Massachusetts Eye and Ear; and receiving research support from the National Institutes of Health (NIH). L. Borish reports consulting for Sanofi-Aventis and receiving research support from Regeneron , GSK , and the NIH . G. Chupp reports serving as a board member, speakers bureau member (advisory), and being a clinical trial principal investigator for AstraZeneca, Genentech, GSK, Circassia, Sanofi-Genzyme, Regeneron, Boehringer Ingelheim, and Boston Scientific. W. Fokkens reports consulting/speaking arrangements with Sanofi and Lyra Therapeutics and receiving research support from GSK , Sanofi , Novartis Chordate , Mylan , ALK , and Allergy diagnostics. P. Gevaert reports consulting for Sanofi, Regeneron, Novartis, Roche, Genentech, AstraZeneca, and 3NT and receiving research support from Argenx and 3NT. D. Kennedy reports consulting for GSK, Intersect ENT, Medtronic, and Neurent; serving on the advisory board of Sinuwave; and patent licensing arrangements with Medtronic Xomed. J. Kim reports consulting for Genentech. T. M. Laidlaw reports consulting for GSK and Regeneron. J. F. Piccirillo reports patent licensing arrangements with the Washington University School of Medicine for a Sino-Nasal Outcome test. J. M. Pinto reports consulting/speaker arrangements with Sanofi, Regeneron, ALK, Genentech, and Stallergenes Greer; owning stock/equity in Om Probiotics; and research support from the NIH . L. T. Roland reports serving as a consultant for Tissium. R. P. Schleimer reports serving as a consultant for Intersect ENT, GSK, Allakos, Aurasense, Merck, BioMarck, Sanofi, AstraZeneca/MedImmune, Genentech, Exicure, Otsuka, Aqualung Therapeutics Corp, Actobio Therapeutics, Lyra Therapeutics, Astellas Pharm Inc, Genzyme/Sanofi Corp, and Celgene Corp; owning stock/equity in Allakos, Aurasense, BioMarck, Exicure, and Aqualung Therapeutics Corp; patent licensing arrangements with Allakos; and receiving research support from the NIH . R. J. Schlosser reports consulting and/or speaker arrangements with Stryker , Olympus , Optinose , GSK , Regeneron , and Roche ; owning stock/equity in Healthy Humming; and receiving research support from Gossamer , Stryker , Optinose , GSK , AstraZeneca , Regeneron , Roche , and Healthy Humming . T. L. Smith reports receiving research support from the NIH . B. K. Tan reports serving on the advisory board of Sanofi-Genzyme and Optinose and owning stock in Allakos. E. Toskala reports consulting for Fiagan, serving on the advisory board of Optinose, and receiving research support from Sanofi . S. Wenzel reports consulting for Sanofi-Aventis, GSK, AstraZeneca, and Pieris and receiving research support from AstraZeneca , Novartis , Sanofi , and Knopp Pharmaceuticals . The rest of the authors declare that they have no relevant conflicts of interest.

Keywords

Clinical trials
Dupilumab
Mepolizumab
Nasal polyposis
Omalizumab
Outcomes
Rhinosinusitis
Type 2 inflammation

ASJC Scopus subject areas

Immunology and Allergy

Access to Document

10.1016/j.jaip.2020.02.023

Cite this

Naclerio, R., Baroody, F., Bachert, C., Bleier, B., Borish, L., Brittain, E., Chupp, G., Fisher, A., Fokkens, W., Gevaert, P., Kennedy, D., Kim, J., Laidlaw, T. M., Lee, J. J., Piccirillo, J. F., Pinto, J. M., Roland, L. T., Schleimer, R. P., Schlosser, R. J., ... Togias, A. (2020). Clinical Research Needs for the Management of Chronic Rhinosinusitis with Nasal Polyps in the New Era of Biologics: A National Institute of Allergy and Infectious Diseases Workshop. Journal of Allergy and Clinical Immunology: In Practice, 8(5), 1532-1549.e1. https://doi.org/10.1016/j.jaip.2020.02.023

@article{f5fee9331c54477fb006d4c914738aed,

title = "Clinical Research Needs for the Management of Chronic Rhinosinusitis with Nasal Polyps in the New Era of Biologics: A National Institute of Allergy and Infectious Diseases Workshop",

abstract = "The development of biologics targeting various aspects of type 2 inflammation for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) will provide clinicians with powerful tools to help treat these patients. However, other therapies are also available, and positioning of biologics in a management algorithm will require comparative trials. In November 2019, the National Institute of Allergy and Infectious Diseases convened a workshop to consider potential future trial designs. Workshop participants represented a wide spectrum of clinical specialties, including otolaryngology, allergy, and pulmonary medicine, as well as expertise in CRSwNP pathophysiology and in trial methodology and statistics. The workshop discussed the current state of knowledge in CRSwNP and considered the advantages and disadvantages of various clinical trial or observational study designs and various clinical outcomes. The output from this workshop, which is presented in this report, will hopefully provide investigators with adequate information and ideas to design future studies and answer critical clinical questions. It will also help clinicians understand the current state of the management of CRSwNP and its gaps and be more able to interpret the new information to come.",

keywords = "Clinical trials, Dupilumab, Mepolizumab, Nasal polyposis, Omalizumab, Outcomes, Rhinosinusitis, Type 2 inflammation",

author = "Robert Naclerio and Fuad Baroody and Claus Bachert and Benjamin Bleier and Larry Borish and Erica Brittain and Geoffrey Chupp and Anat Fisher and Wytske Fokkens and Philippe Gevaert and David Kennedy and Jean Kim and Laidlaw, {Tanya M.} and Lee, {Jake J.} and Piccirillo, {Jay F.} and Pinto, {Jayant M.} and Roland, {Lauren T.} and Schleimer, {Robert P.} and Schlosser, {Rodney J.} and Schwaninger, {Julie M.} and Smith, {Timothy L.} and Tan, {Bruce K.} and Ming Tan and Elina Toskala and Sally Wenzel and Alkis Togias",

note = "Publisher Copyright: {\textcopyright} 2020",

year = "2020",

month = may,

doi = "10.1016/j.jaip.2020.02.023",

language = "English (US)",

volume = "8",

pages = "1532--1549.e1",

journal = "Journal of Allergy and Clinical Immunology: In Practice",

issn = "2213-2198",

publisher = "American Academy of Allergy, Asthma and Immunology",

number = "5",

}

Naclerio, R, Baroody, F, Bachert, C, Bleier, B, Borish, L, Brittain, E, Chupp, G, Fisher, A, Fokkens, W, Gevaert, P, Kennedy, D, Kim, J, Laidlaw, TM, Lee, JJ, Piccirillo, JF, Pinto, JM, Roland, LT, Schleimer, RP, Schlosser, RJ, Schwaninger, JM, Smith, TL, Tan, BK, Tan, M, Toskala, E, Wenzel, S & Togias, A 2020, 'Clinical Research Needs for the Management of Chronic Rhinosinusitis with Nasal Polyps in the New Era of Biologics: A National Institute of Allergy and Infectious Diseases Workshop', Journal of Allergy and Clinical Immunology: In Practice, vol. 8, no. 5, pp. 1532-1549.e1. https://doi.org/10.1016/j.jaip.2020.02.023

Clinical Research Needs for the Management of Chronic Rhinosinusitis with Nasal Polyps in the New Era of Biologics: A National Institute of Allergy and Infectious Diseases Workshop. / Naclerio, Robert; Baroody, Fuad; Bachert, Claus et al.
In: Journal of Allergy and Clinical Immunology: In Practice, Vol. 8, No. 5, 05.2020, p. 1532-1549.e1.

Research output: Contribution to journal › Review article › peer-review

TY - JOUR

T1 - Clinical Research Needs for the Management of Chronic Rhinosinusitis with Nasal Polyps in the New Era of Biologics

T2 - A National Institute of Allergy and Infectious Diseases Workshop

AU - Naclerio, Robert

AU - Baroody, Fuad

AU - Bachert, Claus

AU - Bleier, Benjamin

AU - Borish, Larry

AU - Brittain, Erica

AU - Chupp, Geoffrey

AU - Fisher, Anat

AU - Fokkens, Wytske

AU - Gevaert, Philippe

AU - Kennedy, David

AU - Kim, Jean

AU - Laidlaw, Tanya M.

AU - Lee, Jake J.

AU - Piccirillo, Jay F.

AU - Pinto, Jayant M.

AU - Roland, Lauren T.

AU - Schleimer, Robert P.

AU - Schlosser, Rodney J.

AU - Schwaninger, Julie M.

AU - Smith, Timothy L.

AU - Tan, Bruce K.

AU - Tan, Ming

AU - Toskala, Elina

AU - Wenzel, Sally

AU - Togias, Alkis

PY - 2020/5

Y1 - 2020/5

N2 - The development of biologics targeting various aspects of type 2 inflammation for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) will provide clinicians with powerful tools to help treat these patients. However, other therapies are also available, and positioning of biologics in a management algorithm will require comparative trials. In November 2019, the National Institute of Allergy and Infectious Diseases convened a workshop to consider potential future trial designs. Workshop participants represented a wide spectrum of clinical specialties, including otolaryngology, allergy, and pulmonary medicine, as well as expertise in CRSwNP pathophysiology and in trial methodology and statistics. The workshop discussed the current state of knowledge in CRSwNP and considered the advantages and disadvantages of various clinical trial or observational study designs and various clinical outcomes. The output from this workshop, which is presented in this report, will hopefully provide investigators with adequate information and ideas to design future studies and answer critical clinical questions. It will also help clinicians understand the current state of the management of CRSwNP and its gaps and be more able to interpret the new information to come.

AB - The development of biologics targeting various aspects of type 2 inflammation for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) will provide clinicians with powerful tools to help treat these patients. However, other therapies are also available, and positioning of biologics in a management algorithm will require comparative trials. In November 2019, the National Institute of Allergy and Infectious Diseases convened a workshop to consider potential future trial designs. Workshop participants represented a wide spectrum of clinical specialties, including otolaryngology, allergy, and pulmonary medicine, as well as expertise in CRSwNP pathophysiology and in trial methodology and statistics. The workshop discussed the current state of knowledge in CRSwNP and considered the advantages and disadvantages of various clinical trial or observational study designs and various clinical outcomes. The output from this workshop, which is presented in this report, will hopefully provide investigators with adequate information and ideas to design future studies and answer critical clinical questions. It will also help clinicians understand the current state of the management of CRSwNP and its gaps and be more able to interpret the new information to come.

KW - Clinical trials

KW - Dupilumab

KW - Mepolizumab

KW - Nasal polyposis

KW - Omalizumab

KW - Outcomes

KW - Rhinosinusitis

KW - Type 2 inflammation

UR - http://www.scopus.com/inward/record.url?scp=85083788526&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85083788526&partnerID=8YFLogxK

U2 - 10.1016/j.jaip.2020.02.023

DO - 10.1016/j.jaip.2020.02.023

M3 - Review article

C2 - 32142964

AN - SCOPUS:85083788526

SN - 2213-2198

VL - 8

SP - 1532-1549.e1

JO - Journal of Allergy and Clinical Immunology: In Practice

JF - Journal of Allergy and Clinical Immunology: In Practice

IS - 5

ER -

Naclerio R, Baroody F, Bachert C, Bleier B, Borish L, Brittain E et al. Clinical Research Needs for the Management of Chronic Rhinosinusitis with Nasal Polyps in the New Era of Biologics: A National Institute of Allergy and Infectious Diseases Workshop. Journal of Allergy and Clinical Immunology: In Practice. 2020 May;8(5):1532-1549.e1. doi: 10.1016/j.jaip.2020.02.023

Clinical Research Needs for the Management of Chronic Rhinosinusitis with Nasal Polyps in the New Era of Biologics: A National Institute of Allergy and Infectious Diseases Workshop

Abstract

Funding

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this