Study Assessing Long-teRm Outcomes of dupiluMAb (DUPIXENT®) Treatment in Adult Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

DUPIXENT® Treatment Characteristics

Including but not limited to: usage, dosage, adherence, interruption, place (home or clinic) and frequency of administration

Time frame: Baseline up to 3 years

CRSwNP Treatment Characteristics

Including but not limited to: usage, dosage, adherence, duration and frequency

Time frame: Baseline up to 3 years

Incidence and severity of adverse events (AEs)

Time frame: Baseline up to 3 years

Participant Assessment: Total symptom score (TSS), including sub-scores (nasal congestion [NC] and loss of smell [LOS])

The TSS is a composite score (ranging between 0 and 9) and consisting of the sum of the following symptoms assessed daily: nasal congestion/obstruction, decreased/loss of sense of smell, rhinorrhea (average of anterior/posterior nasal discharge). Higher scores indicate greater symptom burden.

Time frame: Baseline up to 3 years

Physician Assessment: Change in University of Pennsylvania Smell Identification Test (UPSIT) score

The UPSIT (UPSIT 40-odorant test) is a rapid and easy-to-administer method to quantitatively assess human olfactory function.

Time frame: Baseline up to 3 years

Physician Assessment: CT-Lund-Mackay Score

The LMK system is scoring based on CT imaging of the sinuses with points given for degree of opacification: 0 = no opacification, 1 = partial opacification, 2 = total opacification. These points are then applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side. The ostiomeatal complex is graded as 0 = not occluded, or 2 = occluded. The sum of these derives a maximum score of 12 per side and 24 in total.

Time frame: Baseline up to 3 years

Physician Assessment: Nasal Peak Inspiratory Flow (PNIF)

Nasal peak inspiratory flow (NPIF) is a measure of the air flow through both nasal cavities during forced inspiration expressed in liters per minute.

Time frame: Baseline up to 3 years

Physician Assessment: - Forced Expiratory Volume in 1 second (FEV1)

Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled in the first second of a forced exhalation

Time frame: Baseline up to 3 years

Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)

FeNO (Fractional exhaled Nitric Oxiide) is analyzed using a respiratory flow rate of 50 mL/second and reported in ppb.

Time frame: Baseline up to 3 Years

Participant Assessment: Asthma Control Questionnaire, 6-item (ACQ-6)

The ACQ-6 assesses asthma control with scores ranging from 0 (fully controlled; 6=severely uncontrolled).

Time frame: Baseline up to 3 Years

Participant Assessment: Mini Asthma Quality of Life Questionnaire (MiniAQLQ)

The MiniAQLQ is assesses the impact of asthma on health-related quality of life with scores ranging from 1 (maximum impairment) to 7 (no impairment).

Time frame: Baseline up to 3 Years

Participant Assessment: Allergic Rhinitis (AR) using AR Visual Analog Scale (VAS)

The AR-VAS assesses severity of rhinosinusitis symptoms on a 0 (not troublesome) to 10 (worst thinkable troublesome) scale.

Time frame: Baseline up to 3 Years

Participant Assessment: Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)

The MiniRQLQ is an abbreviated version of the RQLQ(S)+12 which assesses health-related quality of life associated with perennial or seasonal allergic rhinitis with scores ranging from 0 (not troubled) to 6 (extremely troubled).

Time frame: Baseline up to 3 Years

Participant Assessment: Sino-Nasal Outcome Test (SNOT-22)

The SNOT-22 assesses the impact of chronic rhinosinusitis on health-related quality of life with scores ranging from 0 to 110; lower scores representing better health related quality of life.

Time frame: Baseline up to 3 Years

Participant Assessment: Patient Oriented Eczema Measure (POEM)

The POEM assesses symptoms of dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping with scores ranging from 0 to 28; higher scores indicate greater symptom burden.

Time frame: Baseline up to 3 Years

Participant Assessment: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-CRSwNP)

The WPAI-CRSwNP measures impairments in work and activities associated with CRSwNP. Scores are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

Time frame: Baseline up to 3 Years

Physician Assessment: Changes of Healthcare Utilization

Resource use collected from medical, hospital, and pharmacy records

Time frame: Baseline up to 3 years

Participant Assessment: Short Form 12

The SF-12 assesses physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/vitality, pain, and general health perception with scores ranging from 0 to 100; lower scores represent greater quality of life impairment.

Time frame: Baseline up to 3 years

Participant Assessment: European Quality of Life 5-Dimensions, 5-Level Questionnaire (EQ-5D-5L)

The EQ 5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and the EQ-VAS records the respondent's self rated health on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).

Time frame: Baseline up to 3 years

Participant Assessment: Global Impression for Symptom Severity, Treatment Satisfaction (Global Patient Assessment)

The Global Patient Assessment is a 2-component questionnaire on symptom severity over the past week and the patient's overall satisfaction with their CRSwNP treatment.

Time frame: Baseline up to 3 years

Physician Assessment: Global Impression for Disease Severity (Global Physician Assessment)

The Global Physician Assessment is a 1-item question asking physicians to rate the severity of their patient's CRSwNP.

Time frame: Baseline up to 3 years