Radiological Versus Clinical 1-Year Outcomes of Dupilumab in Refractory CRSwNP: A Real-Life Study.
CT scan
Lund Mackay
chronic rhinosinusitis
dupilumab
patients reported outcomes
Journal
The Laryngoscope
ISSN: 1531-4995
Titre abrégé: Laryngoscope
Pays: United States
ID NLM: 8607378
Informations de publication
Date de publication:
21 Dec 2023
21 Dec 2023
Historique:
revised:
29
11
2023
received:
30
08
2023
accepted:
04
12
2023
medline:
21
12
2023
pubmed:
21
12
2023
entrez:
21
12
2023
Statut:
aheadofprint
Résumé
To provide real-life evidence on long-term radiological changes in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) treated with dupilumab, and to assess possible differences between radiological and clinical results in terms of endoscopic findings and Patient-Reported-Outcomes (PROs). Consecutive patients treated with dupilumab for recalcitrant CRSwNP were required to undergo CT scan at baseline (T0) and after 12 (T1) since first administration. A group of patients also performed CT scan at 52 weeks (T2) to assess long-term outcomes. At each timepoint, patients underwent nasal endoscopy, assessment of Nasal-Polyp-Score (NPS), Lund-Kennedy-Score (LKS), and had to fill in the 22-item Sinonasal-Outcome-Test (SNOT-22) and Visual-Analogue-Scales (VAS) for sinonasal symptoms. In fifty-three included patients, from T0 to T1 we detected a significant reduction in mean Lund-Mackay score (LM), PROs (SNOT-22, VAS) and endoscopic (NPS, LKS) scores (p < 0.05). In the subset of patients that reached T2 (n = 30), compared to T1, we observed a further significant decrease in mean LM, SNOT-22, VAS, and NPS scores, but not in LKS (p = 0.420). At T1, the highest improvement was observed in PROs (SNOT-22: 56.26%), and polyp size (NPS: 49.83%). Conversely, between T1 and T2, sinus opacification was shown to be the most improved outcome (LM: 36.86%). Our experience showed that poorly controlled CRSwNP patients treated with dupilumab experienced significant improvement in radiologic, endoscopic and clinical disease severity. While in the initial 3 months, PROs garnered attention for showing earlier effectiveness, radiological outcomes revealed sustained and gradual efficacy in a longer term. Level 4. According to the Oxford Center for Evidence-Based Medicine 2011 level of evidence guidelines, this non-randomized retrospective cohort study is classified as level 4 evidence Laryngoscope, 2023.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2023 The American Laryngological, Rhinological and Otological Society, Inc.
Références
Fokkens WJ, Lund V, Bachert C, et al. EUFOREA consensus on biologics for CRSwNP with or without asthma. Allergy. 2019;74(12):2312-2319. https://doi.org/10.1111/all.13875.
Hamilos DL. Chronic rhinosinusitis: epidemiology and medical management. J Allergy Clin Immunol. 2011;128(4):693-707. https://doi.org/10.1016/j.jaci.2011.08.004.
Settipane GA. Epidemiology of nasal polyps. Allergy Asthma Proc. 1996;17(5):231-236. https://doi.org/10.2500/108854196778662246.
Stevens WW, Schleimer RP, Kern RC. Chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol Pract. 2016, ISSN 2213-2198;4(4):565-572.
Giunta G, Pirola F, Giombi F, et al. Care for patients with type-2 chronic rhinosinusitis. J Pers Med. 2023;13:618. https://doi.org/10.3390/jpm13040618.
Bachert C, Bhattacharyya N, Desrosiers M, Khan AH. Burden of disease in chronic rhinosinusitis with nasal polyps. J Asthma Allergy. 2021;14:127-134. https://doi.org/10.2147/JAA.S290424.
Van Crombruggen K, Zhang N, Gevaert P, Tomassen P, Bachert C. Pathogenesis of chronic rhinosinusitis: inflammation. J Allergy Clin Immunol. 2011;128(4):728-732. https://doi.org/10.1016/j.jaci.2011.07.049.
Boita M, Bucca C, Riva G, Heffler E, Rolla G. Release of type 2 cytokines by epithelial cells of nasal polyps. J Immunol Res. 2016;2016:2643297. https://doi.org/10.1155/2016/2643297 Epub 2016 Dec 29. PMID: 28127565; PMCID: PMC5227162.
Hulse KE, Stevens WW, Tan BK, Schleimer RP. Pathogenesis of nasal polyposis. Clin Exp Allergy. 2015;45(2):328-346. https://doi.org/10.1111/cea.12472.
Bachert C, Han JK, Wagenmann M, et al. EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: definitions and management. J Allergy Clin Immunol. 2021, ISSN 0091-6749;147(1):29-36. https://doi.org/10.1016/j.jaci.2020.11.013.
Fokkens WJ, Lund VJ, Hopkins C, et al. European position paper on rhinosinusitis and nasal polyps 2020. Rhinology. 2020;58(Suppl S29):1-464. https://doi.org/10.4193/Rhin20.600 PMID: 32077450.
Fokkens WJ. EPOS2020: a major step forward. Rhinology. 2020;58(1):1. https://doi.org/10.4193/Rhin20.401 PMID: 32078669.
Canonica GW, Malvezzi L, Blasi F, et al. Severe asthma network Italy (SANI). Chronic rhinosinusitis with nasal polyps impact in severe asthma patients: evidences from the severe asthma network Italy (SANI) registry. Respir Med. 2020;166:105947. https://doi.org/10.1016/j.rmed.2020.105947.
Poetker DM, Jakubowski LA, Lal D, Hwang PH, Wright ED, Smith TL. Oral corticosteroids in the management of adult chronic rhinosinusitis with and without nasal polyps: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2013;3(2):104-120. https://doi.org/10.1002/alr.21072.
DeConde AS, Mace JC, Levy JM, et al. Prevalence of polyp recurrence after endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis. Laryngoscope. 2017;127(3):550-555. https://doi.org/10.1002/lary.26391.
Riva G, Tavassoli M, Cravero E, et al. Long-term evaluation of nasal polyposis recurrence: a focus on multiple relapses and nasal cytology. Am J Otolaryngol. 2022;43(2):103325. https://doi.org/10.1016/j.amjoto.2021.103325.
Harb H, Chatila TA. Mechanisms of Dupilumab. Clin Exp Allergy. 2020;50(1):5-14. https://doi.org/10.1111/cea.13491 Epub 2019 Sep 30. PMID: 31505066; PMCID: PMC6930967.
Hurdayal R, Brombacher F. Interleukin-4 receptor alpha: from innate to adaptive immunity in murine models of cutaneous leishmaniasis. Front Immunol. 2017;8:1354. https://doi.org/10.3389/fimmu.2017.01354.
Hendricks AJ, Yosipovitch G, Shi VY. Dupilumab use in dermatologic conditions beyond atopic dermatitis-a systematic review. J Dermatol Treat. 2021;32(1):19-28. https://doi.org/10.1080/09546634.2019.1689227.
Nettis E, Brussino L, Patella V, et al. Effectiveness and safety of dupilumab in patients with chronic rhinosinusitis with nasal polyps and associated comorbidities: a multicentric prospective study in real life. Clin Mol Allergy. 2022;20(1):6. https://doi.org/10.1186/s12948-022-00171-2.
Laidlaw TM, Mullol J, Fan C, et al. Dupilumab improves nasal polyp burden and asthma control in patients with CRSwNP and AERD. J Allergy Clin Immunol Pract. 2019;7(7):2462-2465.e1. https://doi.org/10.1016/j.jaip.2019.03.044 Epub 2019 Apr 4. PMID: 30954643.
Van der Lans RJL, Fokkens WJ, Adriaensen GFJPM, Hoven DR, Drubbel JJ, Reitsma S. Real-life observational cohort verifies high efficacy of dupilumab for chronic rhinosinusitis with nasal polyps. Allergy. 2022;77(2):670-674. https://doi.org/10.1111/all.15134.
De Corso E, Settimi S, Montuori C, et al. Effectiveness of dupilumab in the treatment of patients with severe uncontrolled CRSwNP: a “real-life” observational study in the first year of treatment. J Clin Med. 2022;11(10):2684. https://doi.org/10.3390/jcm11102684 PMID: 35628815; PMCID: PMC9146210.
Lund VJ, Mackay IS. Staging in rhinosinusitis. Rhinology. 1993;31(4):183-184. PMID: 8140385.
Trimarchi M, Vinciguerra A, Rampi A, et al. A prospective study on the efficacy of dupilumab in chronic rhinosinusitis with type 2 inflammation. Acta Otorhinolaryngol Ital. 2022;42(6):538-544. https://doi.org/10.14639/0392-100X-N2156.
Kim J, Naclerio R. Therapeutic potential of dupilumab in the treatment of chronic rhinosinusitis with nasal polyps: evidence to date. Ther Clin Risk Manag. 2020;16:31-37. https://doi.org/10.2147/TCRM.S210648.
DeConde AS, Mace JC, Bodner T, et al. SNOT-22 quality of life domains differentially predict treatment modality selection in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014;4(12):972-979. https://doi.org/10.1002/alr.21408.
Fokkens W, Trigg A, Lee SE, et al. Mepolizumab improvements in health-related quality of life and disease symptoms in a patient population with very severe chronic rhinosinusitis with nasal polyps: psychometric and efficacy analyses from the SYNAPSE study. J Patient Rep Outcomes. 2023;7(1):4. https://doi.org/10.1186/s41687-023-00543-5.
Han JK, Bachert C, Lee SE, et al. Estimating clinically meaningful change of efficacy outcomes in inadequately controlled chronic rhinosinusitis with nasal polyposis. Laryngoscope. 2022;132(2):265-271. https://doi.org/10.1002/lary.29888.
Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal outcome test. Clin Otolaryngol. 2009;34(5):447-454. https://doi.org/10.1111/j.1749-4486.2009.01995.x PMID: 19793277.
Bachert C, Han JK, Desrosiers M, et al. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet. 2019;394(10209):1638-1650. https://doi.org/10.1016/S0140-6736(19)31881-1 Epub 2019 Sep 19.
Jonstam K, Swanson BN, Mannent LP, et al. Dupilumab reduces local type 2 pro-inflammatory biomarkers in chronic rhinosinusitis with nasal polyposis. Allergy. 2019;74(4):743-752. https://doi.org/10.1111/all.13685.
Fujieda S, Matsune S, Takeno S, et al. Dupilumab efficacy in chronic rhinosinusitis with nasal polyps from SINUS-52 is unaffected by eosinophilic status. Allergy. 2022 Jan;77(1):186-196. https://doi.org/10.1111/all.14906 Epub 2021 Jun 4. PMID: 33993501; PMCID: PMC9290136.