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 |
|---|---|
| Pages (from-to) | 1532-1549.e1 |
| Journal | Journal of Allergy and Clinical Immunology: In Practice |
| Volume | 8 |
| Issue number | 5 |
| DOIs | |
| State | Published - May 2020 |
Keywords
- Clinical trials
- Dupilumab
- Mepolizumab
- Nasal polyposis
- Omalizumab
- Outcomes
- Rhinosinusitis
- Type 2 inflammation
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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
N1 - Funding Information: 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. Funding Information: 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. Publisher Copyright: © 2020
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
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 -