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

被引:5
|
作者
Hopkins, Claire [1 ,13 ]
Mullol, Joaquim [2 ]
Khan, Asif H. [3 ]
Lee, Stella E. [4 ]
Wagenmann, Martin [5 ]
Hellings, Peter [6 ]
Fokkens, Wytske [7 ]
Msihid, Jerome [8 ]
Nair, Radhika [9 ]
Kamat, Siddhesh [10 ]
Nash, Scott [10 ]
Radwan, Amr [11 ]
Jacob-Nara, Juby A. [12 ]
Deniz, Yamo [10 ]
Rowe, Paul J. [12 ]
机构
[1] Kings Coll London, Dept Otorhinolaryngol, London, England
[2] Univ Barcelona, Hosp Clin Barcelona, FRCB IDIBAPS, CIBERES, Barcelona, Catalonia, Spain
[3] Sanofi, Global Med Affairs, Chilly Mazarin, France
[4] Harvard Med Sch, Brigham & Womens Hosp, Div Otolaryngol Head & Neck Surg, Boston, MA USA
[5] Dusseldorf Univ Hosp UKD, Dept Otorhinolaryngol, Dusseldorf, Germany
[6] Univ Hosp Leuven, Dept Otorhinolaryngol Head & Neck Surg, Leuven, Belgium
[7] Univ Amsterdam, Dept Otorhinolaryngol, Amsterdam, Netherlands
[8] Sanofi, Hlth Econ & Value Assessment, Gentilly, France
[9] Sanofi, Hlth Econ & Value Assessment, Cambridge, MA USA
[10] Regeneron Pharmaceut Inc, Med Affairs, Tarrytown, NY USA
[11] Regeneron Pharmaceut Inc, Global Med Affairs, Uxbridge, England
[12] Sanofi, Global Med Affairs, Bridgewater, NJ USA
[13] Kings Coll London, Dept Otorhinolaryngol, London WC2R 2LS, England
关键词
chronic rhinosinusitis; nasal polyps; SNOT-22; smell; taste; QUALITY-OF-LIFE;
D O I
10.1002/ohn.627
中图分类号
R76 [耳鼻咽喉科学];
学科分类号
100213 ;
摘要
ObjectivesTo 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, and 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 polyp 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 , identifiers NCT02912468 and NCT02898454, respectively. Visual Abstract. Graphical summary of the study outcomes.*dagger image
引用
收藏
页码:1173 / 1182
页数:10
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