Ther Clin Risk Manag. 2020 Jan 23;16:31-37. doi: 10.2147/TCRM.S210648. eCollection 2020.
Therapeutic Potential of Dupilumab in the Treatment of Chronic Rhinosinusitis with Nasal Polyps: Evidence to Date.
Therapeutics and clinical risk management
Jean Kim, Robert Naclerio
Affiliations
Affiliations
- Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
- Department of Medicine: Allergy and Clinical Immunology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
PMID: 32158216
PMCID: PMC6986240 DOI: 10.2147/TCRM.S210648
Abstract
Chronic rhinosinusitis with nasal polyposis (CRSwNP) is one of the most severe forms of chronic rhinosinusitis. CRSwNP is characterized by nasal and facial congestion, loss of sense of smell, rhinorrhea, and post-nasal drip. Treatments have been ineffective at controlling disease recurrence, despite multiple courses of medical and surgical therapies. Oral glucocorticoid therapy is often used to control exacerbations leaving the patient exposed to steroid-induced adverse effects. Thus, there is a clear unmet need for new treatments to achieve better control of the disease. Advances in understanding Type 2 inflammatory processes that occur in about 80% of the Western world patients with CRSwNP have resulted in new avenues for disease control. Biologics in the form of monoclonal antibodies, which target Type 2 inflammation, have helped control the severest forms of atopic dermatitis and asthma. Treatment regimes for CRSwNP now include biologics. In July 2019, dupilumab was the first monoclonal antibody to gain FDA approval for the treatment of CRSwNP. In this review, we summarize the proof of concept clinical trials and Phase 3 trials leading to approval of dupilumab, an anti-IL4 alpha receptor antagonist that blocks the actions of both IL4 and IL13. These studies show that dupilumab is a proven treatment option to control disease. Collective studies demonstrate a high safety profile. Questions arise as to the best use of dupilumab in the context of current treatment paradigms, and for which sub-population of the varied heterogeneous endotypes of CRSwNP patients. Recognizing the high cost of biologics forces the need for cost-effectiveness analysis.
© 2020 Kim and Naclerio.
Keywords: Type 2 inflammation; chronic rhinosinusitis; dupilumab; nasal polyps
References
- Annu Rev Pathol. 2017 Jan 24;12:331-357 - PubMed
- Adv Ther. 2018 May;35(5):737-748 - PubMed
- Rhinology. 2012 Mar;50(1):1-12 - PubMed
- N Engl J Med. 2018 Jun 28;378(26):2475-2485 - PubMed
- Laryngoscope. 2004 May;114(5):811-3 - PubMed
- Int Forum Allergy Rhinol. 2014 Nov;4(11):861-70 - PubMed
- Allergy. 2020 Jan;75(1):148-157 - PubMed
- JAMA. 2016 Feb 2;315(5):469-79 - PubMed
- Expert Rev Clin Pharmacol. 2018 Dec;11(12):1163-1170 - PubMed
- Am J Rhinol Allergy. 2013 Nov-Dec;27(6):473-8 - PubMed
- Allergy Asthma Immunol Res. 2011 Oct;3(4):226-35 - PubMed
- Curr Allergy Asthma Rep. 2016 Jan;16(1):1 - PubMed
- Clin Exp Otorhinolaryngol. 2017 Mar;10(1):91-96 - PubMed
- Am J Rhinol Allergy. 2014 May-Jun;28(3):260-4 - PubMed
- N Engl J Med. 2018 Jun 28;378(26):2486-2496 - PubMed
- J Allergy Clin Immunol. 2009 Dec;124(6):1352-4.e7 - PubMed
- Dermatol Ther (Heidelb). 2017 Dec;7(4):493-505 - PubMed
- Lancet. 2019 Nov 2;394(10209):1638-1650 - PubMed
- J Allergy Clin Immunol. 2010 May;125(5):1069-1076.e4 - PubMed
- J Allergy Clin Immunol. 2019 Jan;143(1):126-134.e5 - PubMed
- Laryngoscope. 2006 May;116(5):770-5 - PubMed
- Lancet. 2017 Jun 10;389(10086):2287-2303 - PubMed
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