鼻ポリポーシスを伴う慢性副鼻腔炎の民族的に多様な集団におけるデュピルマブ治療効果 (CRSwNP)

CRSwNP participants receiving dupilumab

Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab.

生物学的：デュピルマブ

デュピルマブによる標準治療

Non-CRSwNP surgical controls

Patients undergoing sinonasal surgery for septal deviation, facial trauma with sinus fracture, cerebrospinal fluid (CSF) rhinorrhea, or sinonasal tumor. Single tissue collection at the time of surgery. No dupilumab administered. No subsequent study visits.

Change from baseline in Sino-Nasal outcome test (SNOT-22) score

Change in sinonasal values from baseline will be assessed using the 22-item Sino-Nasal Outcome Test (SNOT-22). The SNOT-22 is a 22-item patient questionnaire used to measure symptom severity and related quality of life in people with chronic rhinosinusitis or nasal problems. Each of the 22 items is measured using a 6-point Likert scale ranging from 0 ("No problem") to 5 ("Worst possible problem"), yielding an overall scoring range of 0-110, such that higher scores are indicative of worsening symptom burden. This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.

Change from baseline in Smell Function

Change in smell function from baseline will be assessed using the University of Pennsylvania Smell Identification Test (UPSIT). The UPSIT is a standardized 40-item "scratch-and-sniff" test of olfactory function. Each participant is provided with four small booklets containing a total of 40 microencapsulated scent strips and is instructed to scratch the strip, sniff the odor, and pick the correct answer from a multiple-choice list of four options per item. Each correct identification of a scratch-and-sniff odor gives one point, yielding an overall possible scoring range of 1-40. Lower scores reflect a reduced ability to identify odors. This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.

Change from baseline in Nasal Peak Flow (NPF)

Change in NPF values from baseline will be evaluated in the clinic. Peak nasal inspiratory flow (PNIF) normal values typically range from 80-180 Liters per minute (L/min) in healthy adults, varying based on age, sex, and physical stature. Higher values are indicative of greater nasal airway patency. Change from baseline values will be expressed in units of L/min. This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.

Change from baseline in urinary Leukotriene E4 (uLTE₄) levels

Change in uLTE₄ levels from baseline will be assessed in the clinic. Urine samples will be collected during each specified timepoint, and samples will be processed and analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) or the appropriate immunoassay. Normal reference ranges for uLTE4 is ≤ 104 picograms per milligram (pg/mg) creatinine. Elevated uLTE₄ levels are indicative of heightened systemic or airway cysteinyl leukotriene activity and serve as a reliable, non-invasive biomarker for several inflammatory, respiratory, and hypersensitivity disorders. Change from baseline values will be expressed in units of pg/mg. This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.

Change from Baseline in Absolute Peripheral Blood Eosinophil Count

Changes in Absolute Eosinophil Count from peripheral blood from baseline will be assessed in the clinic. Blood samples will be drawn during each prespecified timepoint and analyzed using automated hematology analyzers or manual microscopy as part of a Complete Blood Count (CBC) with differential. Absolute Eosinophil Counts (AEC) vary by laboratory but are generally in the range of 0-500 cells per microliter (cells/µL) of blood. Elevated AEC in peripheral blood is indicative of increased in eosinophilic conditions as evident from rashes, worsening pulmonary symptoms and/or neuropathy. Change from baseline values will be expressed in cells/uL. This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.

Change from Baseline in Serum Total Immunoglobulin E (IgE) Levels

Changes in total serum IgE levels from baseline will be assessed in the clinic. Blood samples will be drawn during each prespecified timepoint and analyzed using automated immunoassay techniques to measure the concentration of circulating IgE. Standard reference ranges vary by laboratory assay, age, and individual baseline factors but are generally in the range of 0-100 International Units per milliliter (IU/mL) of blood. Elevated IGe concentrations can be indicative of a number of clinical indications including atopic and allergic diseases. Change from baseline values will be expressed in IU/mL. This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.