Dupilumab in CRSsNP

The CT scan LMK staging system represented the most widely established method of sinus CT scoring. The LMK total score is based on assessment of the CT scan findings for each sinus area (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinus on each side). The extent of mucosal opacification is rated on a 3-point scale ranging from 0 = normal to 2 = total opacification. In addition, the ostiomeatal complex is graded as 0 = not occluded or 2 = occluded. The maximum score is therefore 12 per side; total score ranges from 0 (normal) to 24 (more opacified), corresponding to the sum of all sinuses and the ostiomeatal unit. Higher score indicated worse outcome. Baseline was defined as the last available value up to randomization date and prior to the first dose of study medication.

Time frame: Baseline (Day 1) and Week 24

Population: Intent-to-treat (ITT) population with screening blood eosinophil count ≥300 cells/mm\^3 included all randomized participants with screening blood eosinophil count ≥300 cells/mm\^3 analyzed according to the treatment group allocated by randomization regardless if treatment kit was used or not.

The CT scan LMK staging system represented the most widely established method of sinus CT scoring. The LMK total score is based on assessment of the CT scan findings for each sinus area (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinus on each side). The extent of mucosal opacification is rated on a 3-point scale ranging from 0 = normal to 2 = total opacification. In addition, the ostiomeatal complex is graded as 0 = not occluded or 2 = occluded. The maximum score is therefore 12 per side; total score ranges from 0 (normal) to 24 (more opacified), corresponding to the sum of all sinuses and the ostiomeatal unit. Higher score indicated worse outcome. Baseline was defined as the last available value up to randomization date and prior to the first dose of study medication.

Time frame: Baseline (Day 1) and Week 24

Population: ITT population with screening blood eosinophil count ≥300 cells/mm\^3 included all randomized participants with screening blood eosinophil count ≥300 cells/mm\^3 analyzed according to the treatment group allocated by randomization regardless if treatment kit was used or not. Only those participants with data collected at Week 24 are reported.

The sTSS is a composite score derived from the following individual items: nasal congestion (NC), anterior/posterior rhinorrhea, and facial pain/pressure. Each of the individual items were scored from 0 (no symptoms) to 3 (severe symptoms). The total score ranges from 0 to 9 and consists of the sum of NC, the averaged rhinorrhea item scores, and facial pain/pressure scores. Higher scores on sTSS indicated greater overall symptom severity. Baseline was defined as the last available value up to randomization date and prior to the first dose of study medication.

Time frame: Baseline (Day 1) and Week 24

Population: ITT population with screening blood eosinophil count ≥300 cells/mm\^3 included all randomized participants with screening blood eosinophil count ≥300 cells/mm\^3 analyzed according to the treatment group allocated by randomization regardless if treatment kit was used or not. Only those participants with data collected at Week 24 are reported.

Plasma samples were collected to evaluate antibodies to dupilumab. Pre-existing immunoreactivity was defined as an ADA positive response in the assay at baseline with all post first dose ADA results negative, OR an ADA positive response at baseline with all post first dose ADA responses less than 4-fold over baseline titer levels. Treatment-emergent ADA responses were defined as a positive response in the ADA assay post first dose, when baseline results were negative or missing. Treatment-boosted response was defined as an ADA positive response in the assay post first dose that was greater-than or equal to 4-fold over baseline titer levels, when baseline results were positive. Samples positive in the ADA assay were further characterized for the presence of NAbs.

Time frame: Baseline (Day 1) and up to Week 52

Population: ADA population included all participants in the safety population who had at least 1 non-missing result in the ADA assay after the first dose of the study intervention.

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were AEs that developed, worsened or became serious during the treatment-emergent period. A SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.

Time frame: From the first dose of study drug (Day 1) up to the last dose of study drug administration (373 days) + 98 days, up to 471 days

Population: Safety population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Blood samples were collected at the specified timepoints to evaluate serum concentration of dupilumab.

Time frame: Baseline (Day 1) and Weeks 12, 24 and 52

Population: Pharmacokinetic (PK) population included all participants in the safety population with at least 1 non-missing result for functional dupilumab concentration in serum after the first dose of the study intervention. Only those participants with data collected at specified timepoints are reported.