Figures
- FIGURE 1
AROMA study design. #: assessed at baseline and every 6 months of study; ¶: not required per protocol (data will be collected, if available); +: 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. ƒ: to be completed by patients with concurrent atopic dermatitis; ##: 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; 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; PNIF: peak nasal inspiratory flow; POEM: Patient-Oriented Eczema Measure; 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.
Tables
- TABLE 1
AROMA inclusion and exclusion criteria
Inclusion criteria Patients aged ≥18 years at initiation All patients who are newly initiated on dupilumab for the treatment of chronic rhinosinusitis with nasal polyps according to the country-specific prescribing information (product label or summary of product characteristics) Willing and able to comply with clinic visits and study-related procedures as per protocol Provide informed consent signed by study patient or legally acceptable representative Able to understand and complete study-related questionnaires as per protocol Exclusion criteria Patients who have a contraindication to dupilumab according to the country-specific prescribing information Any previous treatment with dupilumab for any condition Any condition that, in the opinion of the investigator, may interfere with the patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other medical, social or personal conditions and circumstances that can predictably prevent the patient from adequately completing the schedule of visits and assessments Participation in an ongoing interventional or observational study that might, in the treating physician's opinion, influence the assessments for the current study Parallel inclusion in another Sanofi-independent registry might be possible if the patient gives consent - TABLE 2
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 IgEExploratory 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.
Supplementary Material
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Supplementary material 00085-2022.SUPPLEMENT
Visual abstract 00085-2022.visual_abstract
