Effectiveness and Safety of Dupilumab in Patients with Chronic Rhinosinusitis with Nasal Polyps and Associated Comorbidities: a Multicentric Prospective Study in Real Life

Background: Biologics are currently one of the main treatment options for a number of diseases. The IgG4 monoclonal antibody dupilumab targets the Interleukin-4 receptor alpha chain, thus preventing the biological effects of the cytokines IL-4 and IL-13, that are essential for the Th2 response. Several controlled trials showed that dupilumab is effective and safe in patients with atopic dermatitis (AD), severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), thus resulting in approval by regulatory agencies. Aim of the study was to evaluate the efficacy and safety of dupilumab in adult patients with CRSwNP stratified by common overlapping comorbid conditions.

Methods: We performed a multicenter, observational, prospective study enrolling adult patients with severe CRSwNP who had started dupilumab treatment in the context of standard care from January 2021 to October 2021. Data were collected from twentynine Italian secondary care centers for allergy and clinical immunology, all of which were part of the Italian Society of Allergy, Asthma and Clinical Immunology (SIAAIC). A number of efficacy parameters were used. Patient data were compared using the Wilcoxon test for paired data. All statistical analyses were performed with SPSS version 20 (IBM, Armonk, NY, USA).

Results: In total, 82 patients with nasal polyposis were identified. A significant improvement was detected for all the applied efficacy parameters, i.e. 22-item Sino-Nasal Outcome Test (SNOT-22) and bilateral endoscopic nasal polyp score (NPS) scores for CRSwNP, Rhinitis Control Scoring System (RCSS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores for allergic perennial rhinitis, Forced Expiratory Volume in the 1st second (FEV1) and Asthma Quality of Life Questionnaire (AQLQ) scores for asthma, Eczema Area and Severity Index (EASI) and Dermatology Life Quality Index (DLQI) scores for AD. A non-significant improvement was also obtained in the Urticaria Activity Score over 7 days (UAS7) for chronic spontaneous urticaria. Treatment with dupilumab was well tolerated.

Conclusions: These data suggest that dupilumab treatment in patients suffering from CRSwNP and associated comorbidities may be suitable. Such outcome, although confirmation by trials is warranted, suggests the possibility to treat different disorders with a single therapy, with favorable effects especially under the cost-effectiveness aspect.

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References

Marzano A, Genovese G, Casazza G, Fierro M, Dapavo P, Crimi N . Predictors of response to omalizumab and relapse in chronic spontaneous urticaria: a study of 470 patients. J Eur Acad Dermatol Venereol. 2018; 33(5):918-924. DOI: 10.1111/jdv.15350. View

Andrews L, Ralston S, Blomme E, Barnhart K . A snapshot of biologic drug development: Challenges and opportunities. Hum Exp Toxicol. 2015; 34(12):1279-85. DOI: 10.1177/0960327115603594. View

Fleming P, Drucker A . Risk of infection in patients with atopic dermatitis treated with dupilumab: A meta-analysis of randomized controlled trials. J Am Acad Dermatol. 2017; 78(1):62-69.e1. DOI: 10.1016/j.jaad.2017.09.052. View

Fokkens W, Lund V, Mullol J, Bachert C, Alobid I, Baroody F . European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Rhinol Suppl. 2012; 23. View

Klimek L, Chaker A, Deitmer T, Plontke S, Wollenberg B, Bousquet J . [Dupilumab has an additional benefit in treatment of chronic rhinosinusitis with nasal polyps]. HNO. 2021; 69(11):868-877. PMC: 7971351. DOI: 10.1007/s00106-021-01018-z. View

Wang F, Tang X, Wei C, Xu L, Mao H, Luo F . Dupilumab treatment in moderate-to-severe atopic dermatitis: A systematic review and meta-analysis. J Dermatol Sci. 2018; 90(2):190-198. DOI: 10.1016/j.jdermsci.2018.01.016. View

Hanifin J, Cooper K, Ho V, Kang S, Krafchik B, Margolis D . Guidelines of care for atopic dermatitis, developed in accordance with the American Academy of Dermatology (AAD)/American Academy of Dermatology Association "Administrative Regulations for Evidence-Based Clinical Practice Guidelines". J Am Acad Dermatol. 2004; 50(3):391-404. DOI: 10.1016/j.jaad.2003.08.003. View

Xiong X, Zhu M, Wu H, Fan L, Cheng D . Efficacy and safety of dupilumab for the treatment of uncontrolled asthma: a meta-analysis of randomized clinical trials. Respir Res. 2019; 20(1):108. PMC: 6544936. DOI: 10.1186/s12931-019-1065-3. View

Chong L, Piromchai P, Sharp S, Snidvongs K, Webster K, Philpott C . Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021; 3:CD013513. PMC: 8094915. DOI: 10.1002/14651858.CD013513.pub3. View

10.

Nettis E, Dambra P, Loria M, Cenci L, Vena G, Ferrannini A . Mast-cell phenotype in urticaria. Allergy. 2001; 56(9):915. DOI: 10.1034/j.1398-9995.2001.00296.x. View

11.

Silverberg J, Thyssen J, Fahrbach K, Mickle K, Cappelleri J, Romero W . Comparative efficacy and safety of systemic therapies used in moderate-to-severe atopic dermatitis: a systematic literature review and network meta-analysis. J Eur Acad Dermatol Venereol. 2021; 35(9):1797-1810. PMC: 8453983. DOI: 10.1111/jdv.17351. View

12.

Carsuzaa F, Bequignon E, Dufour X, de Bonnecaze G, Lecron J, Favot L . Cytokine Signature and Involvement in Chronic Rhinosinusitis with Nasal Polyps. Int J Mol Sci. 2022; 23(1). PMC: 8745309. DOI: 10.3390/ijms23010417. View

13.

Errichetti E, Stinco G . Recalcitrant chronic urticaria treated with dupilumab: Report of two instances refractory to H1-antihistamines, omalizumab and cyclosporine and brief literature review. Dermatol Ther. 2021; 34(2):e14821. DOI: 10.1111/dth.14821. View

14.

Schatz M, Kosinski M, Yarlas A, Hanlon J, Watson M, Jhingran P . The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009; 124(4):719-23.e1. DOI: 10.1016/j.jaci.2009.06.053. View

15.

Patruno C, Napolitano M, Argenziano G, Peris K, Ortoncelli M, Girolomoni G . Dupilumab therapy of atopic dermatitis of the elderly: a multicentre, real-life study. J Eur Acad Dermatol Venereol. 2020; 35(4):958-964. DOI: 10.1111/jdv.17094. View

16.

Quirce S, Phillips-Angles E, Dominguez-Ortega J, Barranco P . Biologics in the treatment of severe asthma. Allergol Immunopathol (Madr). 2017; 45 Suppl 1:45-49. DOI: 10.1016/j.aller.2017.09.012. View

17.

Juniper E, Svensson K, Mork A, Stahl E . Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir Med. 2005; 99(5):553-8. DOI: 10.1016/j.rmed.2004.10.008. View

18.

Harb H, Chatila T . Mechanisms of Dupilumab. Clin Exp Allergy. 2019; 50(1):5-14. PMC: 6930967. DOI: 10.1111/cea.13491. View

19.

Codispoti C, Mahdavinia M . A call for cost-effectiveness analysis for biologic therapies in chronic rhinosinusitis with nasal polyps. Ann Allergy Asthma Immunol. 2019; 123(3):232-239. DOI: 10.1016/j.anai.2019.07.004. View

20.

Lee J, Simpson R . Dupilumab as a novel therapy for difficult to treat chronic spontaneous urticaria. J Allergy Clin Immunol Pract. 2018; 7(5):1659-1661.e1. DOI: 10.1016/j.jaip.2018.11.018. View