Abstract
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2 inflammatory disease of the nasal and paranasal sinuses. Dupilumab is a monoclonal antibody that blocks the shared receptor component for interleukin-4 and interleukin—13, which are key and central drivers of type 2 inflammation. In clinical trials, dupilumab significantly improved objective and patient-reported measures of CRSwNP versus placebo and was well tolerated. Dupilumab is approved in the EU, USA, and Japan as add-on maintenance treatment for adults with inadequately controlled CRSwNP. There exists an important evidence gap between efficacy and effectiveness data for dupilumab in severe CRSwNP. In order to bridge this gap, the AROMA prospective global registry (NCT04959448) was established. AROMA will collect long-term data on the utilisation, effectiveness and safety of dupilumab for CRSwNP treatment in real-world clinical practice. AROMA will enrol approximately 1000 adults starting dupilumab for severe CRSwNP across 120 global sites. Baseline data will include patient demographics, medical/surgical history and presence of type 2 comorbidities. Effectiveness outcome assessments will include objective measures of CRSwNP assessed as part of routine clinical care and various patient-reported questionnaires. Treatment patterns, concomitant medications and long-term safety will also be recorded. Results from AROMA, the first prospective, real-world, global registry to characterise patients with severe CRSwNP starting dupilumab, will provide evidence on the real impact of dupilumab in patients with CRSwNP and complement the data from the randomised clinical trials. The registry will also provide evidence on disease progression in patients with CRSwNP including those with co-existing diseases.
Footnotes
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Conflict of interest: S. Siddiqui, H. Zhang are former Regeneron employees and may hold stock and/or stock options from Regeneron Pharmaceuticals, Inc.
Conflict of interest: C. Bachert reports advisory board fees and speakers’ fees from Actobiotics, ALK, ASIT Biotech, AstraZeneca, GlaxoSmithKline, Intrexon, Novartis, Sanofi, Stallergenes Greer.
Conflict of interest: A.M. Chaker reports research support, clinical study grants and advisory board fees/speaker honoraria (via Technical University Munich [TUM]) from Abello, ALK, Allergopharma, ASIT Biotech, AstraZeneca, Bencard/Allergen Therapeutics, European Institute of Technology (EIT Health), German Federal Ministry of Education and Research, GlaxoSmithKline, Immunotek, LETI, Lofarma, Novartis, Regeneron Pharmaceuticals Inc., Roche, Sanofi, Zeller.
Conflict of interest: J.K. Han reports advisory board fees from AstraZeneca, Genentech, GlaxoSmithKline, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi.
Conflict of interest: P.W. Hellings reports advisory board fees from Sanofi, Regeneron Pharmaceuticals, Inc.
Conflict of interest: A.T. Peters reports advisory board fees and research grants from Regeneron Pharmaceuticals, Inc., Sanofi, and consultant and research support from Optinose and GlaxoSmithKline.
Conflict of interest: E. Heffler reports research grants from AstraZeneca, Boehringer Ingelheim, Circassia, GlaxoSmithKline, Nestlé Purina, Novartis, Sanofi, Teva, Valeas.
Conflict of interest: S. Kamat, S. Nash, Y. Deniz are employees and may hold stock and/or stock options from Regeneron Pharmaceuticals, Inc.
Conflict of interest: A.H. Khan, L. De Prado Gomez, J.A. Jacob-Nara, P.J. Rowe are employees, and may hold stock and/or stock options in the company from Sanofi.
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- Received February 17, 2022.
- Accepted September 4, 2022.
- Copyright ©The authors 2022
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