Impact of Dupilumab on Sinonasal Symptoms and Outcomes in Severe Chronic Rhinosinusitis With Nasal Polyps

Author:

Hopkins Claire1ORCID,Mullol Joaquim2ORCID,Khan Asif H.3ORCID,Lee Stella E.4ORCID,Wagenmann Martin5ORCID,Hellings Peter6ORCID,Fokkens Wytske7ORCID,Msihid Jérôme8ORCID,Nair Radhika9ORCID,Kamat Siddhesh10ORCID,Nash Scott10ORCID,Radwan Amr11ORCID,Jacob‐Nara Juby A.12ORCID,Deniz Yamo10,Rowe Paul J.12

Affiliation:

1. Department of Otorhinolaryngology King's College London London UK

2. Hospital Clínic Barcelona, FRCB‐IDIBAPS Universitat de Barcelona, CIBERES Barcelona Catalonia Spain

3. Global Medical Affairs, Sanofi Chilly‐Mazarin France

4. Harvard Medical School, Brigham and Women's Hospital Division of Otolaryngology–Head & Neck Surgery Boston Massachusetts USA

5. Department of Otorhinolaryngology Düsseldorf University Hospital (UKD) Düsseldorf Germany

6. Department of Otorhinolaryngology–Head and Neck Surgery University Hospitals Leuven Leuven Belgium

7. Department of Otorhinolaryngology University of Amsterdam Amsterdam The Netherlands

8. Health Economics and Value Assessment, Sanofi Gentilly France

9. Health Economics and Value Assessment, Sanofi Cambridge Massachusetts USA

10. Medical Affairs Regeneron Pharmaceuticals Inc. Tarrytown New York USA

11. Global Medical Affairs Regeneron Pharmaceuticals Inc. Uxbridge UK

12. Global Medical Affairs, Sanofi Bridgewater New Jersey USA

Abstract

AbstractObjectivesTo assess the severity of the top 5 22‐item Sino‐Nasal Outcome Test (SNOT‐22) items ranked most important by patients with chronic rhinosinusitis with nasal polyps (CRSwNP), the effect of dupilumab on these items, and their association with objective disease measures.Study DesignPost hoc analysis of the SINUS‐24 (NCT02912468) and SINUS‐52 (NCT02898454) clinical trials.SettingMultinational, multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group studies.MethodsPatients ranked the SNOT‐22 items most affecting their health at baseline. Item symptom severity (0‐5 scale) was assessed at baseline, Week 24 (W24), and Week 52 (W52). Changes in nasal polyps score (NPS) and Lund–Mackay (LMK) scores were assessed in patients with/without SNOT‐22 items improvements of at least 1 severity group point at W24 and W52.ResultsThe SNOT‐22 items ranked most important at baseline were “decreased sense of smell/taste” (87% of patients), followed by “nasal blockage” (82%), “postnasal discharge” (40%), “thick nasal discharge” (37%), and “wake up at night” (26%); 82%, 61%, 32%, 40%, and 26% of patients reported severe symptoms (score 4 or 5) for these items, respectively. Dupilumab improved score severity for all top 5 items versus placebo at W24 and W52. Improvements in NPS and LMK scores were numerically greater in patients with improvements in the SNOT‐22 top 5 items.ConclusionLoss of smell/taste was ranked as the most important symptom by patients with CRSwNP. Dupilumab reduced the severity of the top 5 most important SNOT‐22 items versus placebo, in parallel with improvements in objective disease measures.Clinical Trial RegistrationSINUS‐24 and SINUS‐52 clinical trials were registered with ClinicalTrials.gov, identifiers NCT02912468 and NCT02898454, respectively.

Publisher

Wiley

Subject

Otorhinolaryngology,Surgery

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