AROMA objectives and end-points
| Objectives | End-points | Assessments |
| Primary | ||
| 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 |
| Secondary | ||
| 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 |
| Exploratory | ||
| 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.