AROMA objectives and end-points

  To longitudinally characterise the long-term effectiveness of dupilumab through assessment of patient-reported symptoms, HRQoL related to CRSwNP and other type 2 comorbidities, and their change over time  Descriptive summary of symptoms, HRQoL and change over time
  ACQ-6#, AR-VAS, eDiary+ (LoS, NC, TSS), EQ-5D-5L#, HCRUQ#, mini-AQLQ#, mini-RQLQ(S)#, POEM#, SF-12, Sniffin Stick Test#, SNOT-22, UPSIT#, WPAI-CRSwNP
  To characterise patients who receive dupilumab for CRSwNP in a real-world setting with respect to their medical history, demographic and disease characteristics, and type 2 comorbidities  Descriptive summary of patients and disease characteristics with CRSwNP and type 2 comorbidities Not mandated per protocol; data will be collected if available for: FENO, LMK-CT, PNIF and spirometry
  To characterise the real-world utilisation of dupilumab for patients with CRSwNP  Descriptive summaries of dupilumab and other CRSwNP treatments used during the study, including the most commonly used treatments, dosage, adherence, interruption, place and frequency of administration (home or clinic)
  To collect patient and physician global assessment of disease severity and treatment satisfaction for patients receiving dupilumab for CRSwNP  Reasons for initiation of new CRSwNP treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching
  Global assessment of disease severity and treatment satisfaction (patient and physician)
  Global patient assessment, global physician assessment#
  To collect long-term safety data for patients receiving dupilumab for CRSwNP  Descriptive summary of adverse eventsƒ  Adverse events, including those attributed to dupilumab and/or to concomitant treatments or procedures
  Not mandated per protocol; data will be collected if available for: blood eosinophils and IgE
  To assess INCS/SCS/OCS treatment patterns in patients with CRSwNP  Descriptive summaries of INCS/SCS/OCS use in CRSwNP patients during both pre- and post-use of dupilumab
  To assess the use of controller medications in overlap patients with comorbid asthma  Descriptive summaries of the use of controller medications in patients with comorbid asthma
  To collect information regarding surgery for CRSwNP in patients treated with dupilumab and recurrence of CRSwNP in these patients  Descriptive summaries of the history of surgeries and recurrence rates of nasal polyposis post-initiation of dupilumab treatment

#: assessed at baseline and every 6 months of study; : assessed at baseline, every 3 months in the first 2 years and every 6 months in the last year of the study; +: electronic diary (eDiary) assessments will be completed daily after an initial 4-week period from the screening/baseline visit, then daily over 2-week time periods commencing at weeks 10, 22, 46, 70, 94, 118 and 142, and at any early termination visit; §: to be completed by patients with concurrent atopic dermatitis; ƒ: assessed throughout the study. ACQ-6: six-item Asthma Control Questionnaire; AR-VAS: Allergic Rhinitis Visual Analogue Scale; CRSwNP: chronic rhinosinusitis with nasal polyps; EQ-5D-5L: European Quality of Life 5-Dimensions, 5-Level Questionnaire; FENO: fractional exhaled nitric oxide; HCRUQ: Healthcare Resource Utilization Questionnaire; HRQoL: health-related quality of life; INCS: intranasal corticosteroid; LMK-CT: Lund–Mackay computed tomography; LoS: loss of smell score; mini-AQLQ: Mini Asthma Quality of Life Questionnaire; mini-RQLQ(S): Mini Standardised Rhinoconjunctivitis Quality of Life Questionnaire for patients ≥12 years of age; NC: nasal congestion/obstruction score; OCS: oral corticosteroid; PNIF: peak nasal inspiratory flow; POEM: Patient-Oriented Eczema Measure; SCS: systemic corticosteroid; SF-12: 12-item Short-Form; SNOT-22: 22-item Sino-Nasal Outcome Test; TSS: total symptom score; UPSIT: University of Pennsylvania Smell Identification Test; WPAI-CRSwNP: Work Productivity and Activity Impairment Questionnaire for CRSwNP.