Improvements in Objective and Subjective Measures of Chronic Cough with Gefapixant: A Pooled Phase 3 Efficacy Analysis of Predefined Subgroups

Jaclyn A Smith; Surinder S Birring; Peter V Dicpinigaitis; Lorcan P McGarvey; Alyn H Morice; Ian D Pavord; Imran Satia; Stuart Green; Beata Iskold; Carmen La Rosa; Qing Li; Allison Martin Nguyen; Jonathan Schelfhout; David Muccino

doi:10.1007/s00408-022-00553-y

Improvements in Objective and Subjective Measures of Chronic Cough with Gefapixant: A Pooled Phase 3 Efficacy Analysis of Predefined Subgroups

Jaclyn A Smith, Surinder S Birring, Peter V Dicpinigaitis, Lorcan P McGarvey, Alyn H Morice, Ian D Pavord, Imran Satia, Stuart Green, Beata Iskold, Carmen La Rosa, Qing Li, Allison Martin Nguyen, Jonathan Schelfhout, David Muccino

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Abstract

INTRODUCTION: In phase 3 trials (COUGH-1/COUGH-2), gefapixant 45 mg twice daily significantly reduced 24-h cough frequency vs placebo in refractory or unexplained chronic cough (RCC or UCC).

METHODS: Here, the efficacy of gefapixant 45 mg vs placebo was evaluated across COUGH-1/COUGH-2 in predefined subgroups based on sex, region, age, cough duration, cough severity, cough frequency, and diagnosis (RCC, UCC). Awake cough frequency reductions at Week 12 and LCQ response rates (i.e., ≥ 1.3-point improvement) at Week 24 were assessed.

RESULTS: Among 1360 participants analyzed, gefapixant 45 mg resulted in consistent awake cough frequency reductions overall and across predefined subgroups at Week 12. Gefapixant also resulted in improved LCQ scores across subgroups at Week 24; ≥ 70% of participants in each subgroup treated with gefapixant 45 mg had an LCQ response.

CONCLUSION: These data suggest gefapixant 45 mg provides consistent objective and subjective efficacy across subgroups of individuals with RCC or UCC.

Original language	English
Pages (from-to)	423-429
Number of pages	7
Journal	Lung
Volume	200
Issue number	4
Early online date	27 Jul 2022
DOIs	https://doi.org/10.1007/s00408-022-00553-y
Publication status	Published - 01 Aug 2022

Bibliographical note

Keywords

Carcinoma, Renal Cell
Chronic Disease
Cough/diagnosis
Humans
Kidney Neoplasms
Pyrimidines
Sulfonamides/therapeutic use

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10.1007/s00408-022-00553-yLicence: CC BY

Improvements in Objective and Subjective Measures of Chronic Cough with Gefapixant: A Pooled Phase 3 Efcacy Analysis of Predefned Subgroups
Copyright 2022 the authors. This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
Final published version, 499 KBLicence: CC BY

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Smith, J. A., Birring, S. S., Dicpinigaitis, P. V., McGarvey, L. P., Morice, A. H., Pavord, I. D., Satia, I., Green, S., Iskold, B., La Rosa, C., Li, Q., Martin Nguyen, A., Schelfhout, J., & Muccino, D. (2022). Improvements in Objective and Subjective Measures of Chronic Cough with Gefapixant: A Pooled Phase 3 Efficacy Analysis of Predefined Subgroups. Lung, 200(4), 423-429. https://doi.org/10.1007/s00408-022-00553-y

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title = "Improvements in Objective and Subjective Measures of Chronic Cough with Gefapixant: A Pooled Phase 3 Efficacy Analysis of Predefined Subgroups",

abstract = "INTRODUCTION: In phase 3 trials (COUGH-1/COUGH-2), gefapixant 45 mg twice daily significantly reduced 24-h cough frequency vs placebo in refractory or unexplained chronic cough (RCC or UCC).METHODS: Here, the efficacy of gefapixant 45 mg vs placebo was evaluated across COUGH-1/COUGH-2 in predefined subgroups based on sex, region, age, cough duration, cough severity, cough frequency, and diagnosis (RCC, UCC). Awake cough frequency reductions at Week 12 and LCQ response rates (i.e., ≥ 1.3-point improvement) at Week 24 were assessed.RESULTS: Among 1360 participants analyzed, gefapixant 45 mg resulted in consistent awake cough frequency reductions overall and across predefined subgroups at Week 12. Gefapixant also resulted in improved LCQ scores across subgroups at Week 24; ≥ 70% of participants in each subgroup treated with gefapixant 45 mg had an LCQ response.CONCLUSION: These data suggest gefapixant 45 mg provides consistent objective and subjective efficacy across subgroups of individuals with RCC or UCC.",

keywords = "Carcinoma, Renal Cell, Chronic Disease, Cough/diagnosis, Humans, Kidney Neoplasms, Pyrimidines, Sulfonamides/therapeutic use",

author = "Smith, {Jaclyn A} and Birring, {Surinder S} and Dicpinigaitis, {Peter V} and McGarvey, {Lorcan P} and Morice, {Alyn H} and Pavord, {Ian D} and Imran Satia and Stuart Green and Beata Iskold and {La Rosa}, Carmen and Qing Li and {Martin Nguyen}, Allison and Jonathan Schelfhout and David Muccino",

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year = "2022",

month = aug,

day = "1",

doi = "10.1007/s00408-022-00553-y",

language = "English",

volume = "200",

pages = "423--429",

journal = "Lung",

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Smith, JA, Birring, SS, Dicpinigaitis, PV, McGarvey, LP, Morice, AH, Pavord, ID, Satia, I, Green, S, Iskold, B, La Rosa, C, Li, Q, Martin Nguyen, A, Schelfhout, J & Muccino, D 2022, 'Improvements in Objective and Subjective Measures of Chronic Cough with Gefapixant: A Pooled Phase 3 Efficacy Analysis of Predefined Subgroups', Lung, vol. 200, no. 4, pp. 423-429. https://doi.org/10.1007/s00408-022-00553-y

TY - JOUR

T1 - Improvements in Objective and Subjective Measures of Chronic Cough with Gefapixant: A Pooled Phase 3 Efficacy Analysis of Predefined Subgroups

AU - Smith, Jaclyn A

AU - Birring, Surinder S

AU - Dicpinigaitis, Peter V

AU - McGarvey, Lorcan P

AU - Morice, Alyn H

AU - Pavord, Ian D

AU - Satia, Imran

AU - Green, Stuart

AU - Iskold, Beata

AU - La Rosa, Carmen

AU - Li, Qing

AU - Martin Nguyen, Allison

AU - Schelfhout, Jonathan

AU - Muccino, David

PY - 2022/8/1

Y1 - 2022/8/1

N2 - INTRODUCTION: In phase 3 trials (COUGH-1/COUGH-2), gefapixant 45 mg twice daily significantly reduced 24-h cough frequency vs placebo in refractory or unexplained chronic cough (RCC or UCC).METHODS: Here, the efficacy of gefapixant 45 mg vs placebo was evaluated across COUGH-1/COUGH-2 in predefined subgroups based on sex, region, age, cough duration, cough severity, cough frequency, and diagnosis (RCC, UCC). Awake cough frequency reductions at Week 12 and LCQ response rates (i.e., ≥ 1.3-point improvement) at Week 24 were assessed.RESULTS: Among 1360 participants analyzed, gefapixant 45 mg resulted in consistent awake cough frequency reductions overall and across predefined subgroups at Week 12. Gefapixant also resulted in improved LCQ scores across subgroups at Week 24; ≥ 70% of participants in each subgroup treated with gefapixant 45 mg had an LCQ response.CONCLUSION: These data suggest gefapixant 45 mg provides consistent objective and subjective efficacy across subgroups of individuals with RCC or UCC.

AB - INTRODUCTION: In phase 3 trials (COUGH-1/COUGH-2), gefapixant 45 mg twice daily significantly reduced 24-h cough frequency vs placebo in refractory or unexplained chronic cough (RCC or UCC).METHODS: Here, the efficacy of gefapixant 45 mg vs placebo was evaluated across COUGH-1/COUGH-2 in predefined subgroups based on sex, region, age, cough duration, cough severity, cough frequency, and diagnosis (RCC, UCC). Awake cough frequency reductions at Week 12 and LCQ response rates (i.e., ≥ 1.3-point improvement) at Week 24 were assessed.RESULTS: Among 1360 participants analyzed, gefapixant 45 mg resulted in consistent awake cough frequency reductions overall and across predefined subgroups at Week 12. Gefapixant also resulted in improved LCQ scores across subgroups at Week 24; ≥ 70% of participants in each subgroup treated with gefapixant 45 mg had an LCQ response.CONCLUSION: These data suggest gefapixant 45 mg provides consistent objective and subjective efficacy across subgroups of individuals with RCC or UCC.

KW - Carcinoma, Renal Cell

KW - Chronic Disease

KW - Cough/diagnosis

KW - Humans

KW - Kidney Neoplasms

KW - Pyrimidines

KW - Sulfonamides/therapeutic use

U2 - 10.1007/s00408-022-00553-y

DO - 10.1007/s00408-022-00553-y

M3 - Article

C2 - 35895098

VL - 200

SP - 423

EP - 429

JO - Lung

JF - Lung

SN - 0341-2040

IS - 4

ER -

Improvements in Objective and Subjective Measures of Chronic Cough with Gefapixant: A Pooled Phase 3 Efficacy Analysis of Predefined Subgroups

Abstract

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Keywords

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