Dupilumab improves health related quality of life: Results from the phase 3 SINUS studies

Stella E. Lee; Claire Hopkins; Joaquim Mullol; Jérôme Msihid; Isabelle Guillemin; Nikhil Amin; Leda P. Mannent; Yongtao Li; Shahid Siddiqui; Chien Chia Chuang; Siddhesh Kamat; Asif H. Khan

doi:10.1111/all.15222

Dupilumab improves health related quality of life: Results from the phase 3 SINUS studies

Stella E. Lee^*, Claire Hopkins, Joaquim Mullol, Jérôme Msihid, Isabelle Guillemin, Nikhil Amin, Leda P. Mannent, Yongtao Li, Shahid Siddiqui, Chien Chia Chuang, Siddhesh Kamat, Asif H. Khan

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

32 Citations (Scopus)

Abstract

Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2-mediated inflammatory disease with high symptom burden and reduced health-related quality of life (HRQoL). This report aimed to comprehensively understand the effects of dupilumab on domains of HRQoL, their individual elements, and health status in patients with severe CRSwNP from phase 3 SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) trials. Methods: Patients were randomized to dupilumab (n = 438) or placebo (n = 286) for 24 weeks (SINUS-24), or 52 weeks (SINUS-52). Disease-specific HRQoL using 22-item sino-nasal outcome test (SNOT-22), and health status using EuroQoL-visual analog scale (EQ-VAS) was evaluated in the pooled intention-to-treat (ITT) population (Week 24), SINUS-52 ITT (Week 52) and in the subgroups with/without asthma; non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD); and prior sinus surgery. Results: At baseline, patients had poor disease-specific HRQoL and general health status and identified “Decreased sense of smell/taste” and “Nasal blockage” as the most important symptoms. Dupilumab significantly improved SNOT-22 total, domain (Nasal, Sleep, Function, Emotion, and Ear/facial), and 22-item scores, and EQ-VAS, at Week 24 vs placebo (all p <.0001), with continued improvements to Week 52 in SINUS-52. Improvements occurred irrespective of comorbid asthma, NSAID-ERD, or prior surgery. A significantly greater proportion of dupilumab-treated patients exceeded clinically meaningful thresholds for SNOT-22 total score and EQ-VAS vs placebo (all subgroups p <.05 except patients without surgery at Week 24). Conclusions: Dupilumab treatment led to significant clinically meaningful improvements across all aspects of disease-specific HRQoL, and general health status in patients with severe CRSwNP.

Original language	English
Pages (from-to)	2211-2221
Number of pages	11
Journal	Allergy: European Journal of Allergy and Clinical Immunology
Volume	77
Issue number	7
DOIs	https://doi.org/10.1111/all.15222
Publication status	Published - Jul 2022

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10.1111/all.15222

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@article{722650c1eb8d4abca3cce9a780f15fd7,

title = "Dupilumab improves health related quality of life: Results from the phase 3 SINUS studies",

abstract = "Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2-mediated inflammatory disease with high symptom burden and reduced health-related quality of life (HRQoL). This report aimed to comprehensively understand the effects of dupilumab on domains of HRQoL, their individual elements, and health status in patients with severe CRSwNP from phase 3 SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) trials. Methods: Patients were randomized to dupilumab (n = 438) or placebo (n = 286) for 24 weeks (SINUS-24), or 52 weeks (SINUS-52). Disease-specific HRQoL using 22-item sino-nasal outcome test (SNOT-22), and health status using EuroQoL-visual analog scale (EQ-VAS) was evaluated in the pooled intention-to-treat (ITT) population (Week 24), SINUS-52 ITT (Week 52) and in the subgroups with/without asthma; non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD); and prior sinus surgery. Results: At baseline, patients had poor disease-specific HRQoL and general health status and identified “Decreased sense of smell/taste” and “Nasal blockage” as the most important symptoms. Dupilumab significantly improved SNOT-22 total, domain (Nasal, Sleep, Function, Emotion, and Ear/facial), and 22-item scores, and EQ-VAS, at Week 24 vs placebo (all p <.0001), with continued improvements to Week 52 in SINUS-52. Improvements occurred irrespective of comorbid asthma, NSAID-ERD, or prior surgery. A significantly greater proportion of dupilumab-treated patients exceeded clinically meaningful thresholds for SNOT-22 total score and EQ-VAS vs placebo (all subgroups p <.05 except patients without surgery at Week 24). Conclusions: Dupilumab treatment led to significant clinically meaningful improvements across all aspects of disease-specific HRQoL, and general health status in patients with severe CRSwNP.",

author = "Lee, {Stella E.} and Claire Hopkins and Joaquim Mullol and J{\'e}r{\^o}me Msihid and Isabelle Guillemin and Nikhil Amin and Mannent, {Leda P.} and Yongtao Li and Shahid Siddiqui and Chuang, {Chien Chia} and Siddhesh Kamat and Khan, {Asif H.}",

note = "Funding Information: Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifiers: NCT02912468 (SINUS‐24) and NCT02898454 (SINUS‐52). Medical writing/editorial assistance provided by Zach Dixon, PhD, of Adelphi Group, funded by Sanofi‐Genzyme and Regeneron Pharmaceuticals, Inc. Funding Information: Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifiers: NCT02912468 (SINUS-24) and NCT02898454 (SINUS-52). Medical writing/editorial assistance provided by Zach Dixon, PhD, of Adelphi Group, funded by Sanofi-Genzyme and Regeneron Pharmaceuticals, Inc. Funding Information: Stella E. Lee: Allakos, AstraZeneca, GSK, Knopp Biosciences, Sanofi – clinical trial funding; AstraZeneca, Genentech, GSK, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi – advisory board member. Claire Hopkins: GSK, Optinose, Sanofi‐Genzyme, Smith and Nephew – advisory board member. Joaquim Mullol: ALK, AstraZeneca, Genentech, GSK, Menarini, Mitsubishi Tanabe Pharma, MSD, Mylan‐Meda Pharmaceuticals, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Uriach – clinical trial funding, advisory board member, or speaker fees; Mylan‐Meda Pharmaceuticals, Uriach – research grants. J{\'e}r{\^o}me Msihid, Leda P. Mannent, Yongtao Li, Chien‐Chia Chuang, Asif H. Khan: Sanofi – employees, may hold stock and/or stock options in the company. Isabelle Guillemin: Sanofi – employee at the time of manuscript development. Nikhil Amin, Shahid Siddiqui, Siddhesh Kamat: Regeneron Pharmaceuticals, Inc. – employees and shareholders. Publisher Copyright: {\textcopyright} 2022 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.",

year = "2022",

month = jul,

doi = "10.1111/all.15222",

language = "English",

volume = "77",

pages = "2211--2221",

journal = "Allergy: European Journal of Allergy and Clinical Immunology",

issn = "0105-4538",

publisher = "John Wiley and sons",

number = "7",

}

TY - JOUR

T1 - Dupilumab improves health related quality of life

T2 - Results from the phase 3 SINUS studies

AU - Lee, Stella E.

AU - Hopkins, Claire

AU - Mullol, Joaquim

AU - Msihid, Jérôme

AU - Guillemin, Isabelle

AU - Amin, Nikhil

AU - Mannent, Leda P.

AU - Li, Yongtao

AU - Siddiqui, Shahid

AU - Chuang, Chien Chia

AU - Kamat, Siddhesh

AU - Khan, Asif H.

N1 - Funding Information: Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifiers: NCT02912468 (SINUS‐24) and NCT02898454 (SINUS‐52). Medical writing/editorial assistance provided by Zach Dixon, PhD, of Adelphi Group, funded by Sanofi‐Genzyme and Regeneron Pharmaceuticals, Inc. Funding Information: Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifiers: NCT02912468 (SINUS-24) and NCT02898454 (SINUS-52). Medical writing/editorial assistance provided by Zach Dixon, PhD, of Adelphi Group, funded by Sanofi-Genzyme and Regeneron Pharmaceuticals, Inc. Funding Information: Stella E. Lee: Allakos, AstraZeneca, GSK, Knopp Biosciences, Sanofi – clinical trial funding; AstraZeneca, Genentech, GSK, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi – advisory board member. Claire Hopkins: GSK, Optinose, Sanofi‐Genzyme, Smith and Nephew – advisory board member. Joaquim Mullol: ALK, AstraZeneca, Genentech, GSK, Menarini, Mitsubishi Tanabe Pharma, MSD, Mylan‐Meda Pharmaceuticals, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Uriach – clinical trial funding, advisory board member, or speaker fees; Mylan‐Meda Pharmaceuticals, Uriach – research grants. Jérôme Msihid, Leda P. Mannent, Yongtao Li, Chien‐Chia Chuang, Asif H. Khan: Sanofi – employees, may hold stock and/or stock options in the company. Isabelle Guillemin: Sanofi – employee at the time of manuscript development. Nikhil Amin, Shahid Siddiqui, Siddhesh Kamat: Regeneron Pharmaceuticals, Inc. – employees and shareholders. Publisher Copyright: © 2022 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

PY - 2022/7

Y1 - 2022/7

N2 - Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2-mediated inflammatory disease with high symptom burden and reduced health-related quality of life (HRQoL). This report aimed to comprehensively understand the effects of dupilumab on domains of HRQoL, their individual elements, and health status in patients with severe CRSwNP from phase 3 SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) trials. Methods: Patients were randomized to dupilumab (n = 438) or placebo (n = 286) for 24 weeks (SINUS-24), or 52 weeks (SINUS-52). Disease-specific HRQoL using 22-item sino-nasal outcome test (SNOT-22), and health status using EuroQoL-visual analog scale (EQ-VAS) was evaluated in the pooled intention-to-treat (ITT) population (Week 24), SINUS-52 ITT (Week 52) and in the subgroups with/without asthma; non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD); and prior sinus surgery. Results: At baseline, patients had poor disease-specific HRQoL and general health status and identified “Decreased sense of smell/taste” and “Nasal blockage” as the most important symptoms. Dupilumab significantly improved SNOT-22 total, domain (Nasal, Sleep, Function, Emotion, and Ear/facial), and 22-item scores, and EQ-VAS, at Week 24 vs placebo (all p <.0001), with continued improvements to Week 52 in SINUS-52. Improvements occurred irrespective of comorbid asthma, NSAID-ERD, or prior surgery. A significantly greater proportion of dupilumab-treated patients exceeded clinically meaningful thresholds for SNOT-22 total score and EQ-VAS vs placebo (all subgroups p <.05 except patients without surgery at Week 24). Conclusions: Dupilumab treatment led to significant clinically meaningful improvements across all aspects of disease-specific HRQoL, and general health status in patients with severe CRSwNP.

AB - Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2-mediated inflammatory disease with high symptom burden and reduced health-related quality of life (HRQoL). This report aimed to comprehensively understand the effects of dupilumab on domains of HRQoL, their individual elements, and health status in patients with severe CRSwNP from phase 3 SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) trials. Methods: Patients were randomized to dupilumab (n = 438) or placebo (n = 286) for 24 weeks (SINUS-24), or 52 weeks (SINUS-52). Disease-specific HRQoL using 22-item sino-nasal outcome test (SNOT-22), and health status using EuroQoL-visual analog scale (EQ-VAS) was evaluated in the pooled intention-to-treat (ITT) population (Week 24), SINUS-52 ITT (Week 52) and in the subgroups with/without asthma; non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD); and prior sinus surgery. Results: At baseline, patients had poor disease-specific HRQoL and general health status and identified “Decreased sense of smell/taste” and “Nasal blockage” as the most important symptoms. Dupilumab significantly improved SNOT-22 total, domain (Nasal, Sleep, Function, Emotion, and Ear/facial), and 22-item scores, and EQ-VAS, at Week 24 vs placebo (all p <.0001), with continued improvements to Week 52 in SINUS-52. Improvements occurred irrespective of comorbid asthma, NSAID-ERD, or prior surgery. A significantly greater proportion of dupilumab-treated patients exceeded clinically meaningful thresholds for SNOT-22 total score and EQ-VAS vs placebo (all subgroups p <.05 except patients without surgery at Week 24). Conclusions: Dupilumab treatment led to significant clinically meaningful improvements across all aspects of disease-specific HRQoL, and general health status in patients with severe CRSwNP.

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SN - 0105-4538

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JO - Allergy: European Journal of Allergy and Clinical Immunology

JF - Allergy: European Journal of Allergy and Clinical Immunology

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ER -

Dupilumab improves health related quality of life: Results from the phase 3 SINUS studies

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