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AROMA: real-world global registry of dupilumab for chronic rhinosinusitis with nasal polyps

Shahid Siddiqui, Claus Bachert, Adam M. Chaker, Joseph K. Han, Peter W. Hellings, Anju T. Peters, Enrico Heffler, Siddhesh Kamat, Haixin Zhang, Scott Nash, Asif H. Khan, Lucia De Prado Gomez, Juby A. Jacob-Nara, Paul J. Rowe, Yamo Deniz
ERJ Open Research 2022 8: 00085-2022; DOI: 10.1183/23120541.00085-2022
Shahid Siddiqui
1Medical Affairs, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
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Claus Bachert
2Upper Airways Research Laboratory and Department of Otorhinolaryngology, Ghent University, Ghent, Belgium
3Division of ENT Diseases, CLINTEC, Karolinska Institutet, Stockholm, Sweden
4Sun Yat-sen University, The First Affiliated Hospital, Guangzhou, China
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Adam M. Chaker
5TUM Medical School, Klinikum rechts der Isar, Department of Otolaryngology and ZAUM, Technical University of Munich, Munich, Germany
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Joseph K. Han
6Department of Otolaryngology and Head and Neck Surgery, Eastern Virginia Medical School, Norfolk, VA, USA
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Peter W. Hellings
2Upper Airways Research Laboratory and Department of Otorhinolaryngology, Ghent University, Ghent, Belgium
7Department of Otorhinolaryngology – Head and Neck Surgery, University Hospitals Leuven, Leuven, Belgium
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Anju T. Peters
8Division of Allergy and Immunology and Sinus and Allergy Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA
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  • ORCID record for Anju T. Peters
Enrico Heffler
9Allergy and Respiratory Diseases, Humanitas Clinical and Research Center IRCCS, Milan, Italy
10Department of Biomedical Sciences, Humanitas University, Milan, Italy
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Siddhesh Kamat
1Medical Affairs, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
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Haixin Zhang
1Medical Affairs, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
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Scott Nash
1Medical Affairs, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
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  • For correspondence: scott.nash@regeneron.com
Asif H. Khan
11Global Medical Affairs, Sanofi, Chilly-Mazarin, France
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Lucia De Prado Gomez
12Global Medical Affairs, Sanofi, Reading, UK
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Juby A. Jacob-Nara
13Global Medical Affairs, Sanofi, Bridgewater, NJ, USA
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Paul J. Rowe
13Global Medical Affairs, Sanofi, Bridgewater, NJ, USA
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Yamo Deniz
1Medical Affairs, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
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  • Article
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    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

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  • Supplementary Materials
  • 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

    ObjectivesEnd-pointsAssessments
    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.

    Supplementary Materials

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    • Supplementary Material

      Please note: supplementary material is not edited by the Editorial Office, and is uploaded as it has been supplied by the author.

      Supplementary material 00085-2022.SUPPLEMENT

      Visual abstract 00085-2022.visual_abstract

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    AROMA: real-world global registry of dupilumab for chronic rhinosinusitis with nasal polyps
    Shahid Siddiqui, Claus Bachert, Adam M. Chaker, Joseph K. Han, Peter W. Hellings, Anju T. Peters, Enrico Heffler, Siddhesh Kamat, Haixin Zhang, Scott Nash, Asif H. Khan, Lucia De Prado Gomez, Juby A. Jacob-Nara, Paul J. Rowe, Yamo Deniz
    ERJ Open Research Oct 2022, 8 (4) 00085-2022; DOI: 10.1183/23120541.00085-2022

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    AROMA: real-world global registry of dupilumab for chronic rhinosinusitis with nasal polyps
    Shahid Siddiqui, Claus Bachert, Adam M. Chaker, Joseph K. Han, Peter W. Hellings, Anju T. Peters, Enrico Heffler, Siddhesh Kamat, Haixin Zhang, Scott Nash, Asif H. Khan, Lucia De Prado Gomez, Juby A. Jacob-Nara, Paul J. Rowe, Yamo Deniz
    ERJ Open Research Oct 2022, 8 (4) 00085-2022; DOI: 10.1183/23120541.00085-2022
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