Real life effectiveness of biologics in the treatment of patients with chronic rhinosinusitis with nasosinusal polyposis
Abstract Introduction and objective: Nowadays, treatment proposals for patients with recurrent sinonasal polyposis are based on the use of local intranasal corticosteroid therapy based on topical inhalers, cycles of systemic corticosteroids and endoscopic nasal surgery. Biological therapy is gaining more and more prominence in the treatment of this pathology. The objective of this work is based on determining which biological treatment of those administered today for this disease is more effective in managing symptoms and in its evolution. Method: Retrospective study of 21 patients with chronic rhinosinusitis with sinonasal polyposis and asthma under treatment with biological therapy at the University Hospital of Fuenlabrada. Using a Wilcoxon signed-rank study, we will analyze the efficacy of the different biological treatments administered. Results: A statistical significance with p = <0, 001 was evidenced in terms of the improvement of the symptoms suffered by the study patients (with the exception of smell) as well as an improvement in the Nasal Polyp Score of 3 points. The Wilconxon test result was statistical significance with p = <0, 001. Discussion: The data obtained in this study agree with those obtained in studies on biological therapy in CRSwNP. Remarkable reductions in the disease burden of CRSwNP have been documented objectively and subjectively. This is consistent with the fact that our patients required fewer reinterventions throughout the procedure. Conclusions: In our study, the efficacy of biological therapy has been corroborated in practically all the data analyzed. However, it has not been possible to demonstrate the relevance of one type of therapy over another.
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Fokkens WJ, Lund V, Bachert C, Mullol J, Bjermer L, Bousquet J, 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
Bachert C, Desrosiers MY, Hellings PW, Laidlaw TM. The Role of Biologics in Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2021;9(3):1099-1106. https://doi.org/10.1016/j.jaip.2020.11.017
Bachert C. Biologics in chronic rhinosinusitis with nasal polyps. Zhang L, Bachert C, editors. Chronic Rhinosinusitis: The Mucosal Concept. Springer Nature Singapore. 2022:411-21.
Borish L, Cohen NA, Chupp G, Hopkins C, Wagenmann M, Sousa AR, et al. Evaluating enrollment and outcome criteria in trials of biologics for chronic rhinosinusitis with nasal polyps. Ann Allergy Asthma Immunol. 2022;129(2):160-168. https://doi.org/10.1016/j.anai.2022.04.004
Bachert C, Han JK, Desrosiers M, Hellings PW, Amin N, Lee SE, 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
Gevaert P, Omachi TA, Corren J, Mullol J, Han J, Lee SE, et al. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials. J Allergy Clin Immunol. 2020; 146(3):595-605. https://doi.org/10.1016/j.jaci.2020.05.032
Han JK, Bachert C, Fokkens W, Desrosiers M, Wagenmann M, Lee SE, et al. SYNAPSE study investigators. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021; 9(10):1141-1153. https://doi.org/10.1016/S2213-2600(21)00097-7
Bachert C, Gevaert P, Hellings P. Biotherapeutics in Chronic Rhinosinusitis with and without Nasal Polyps. J Allergy Clin Immunol Pract. 2017;5(6):1512-1516. https://doi.org/10.1016/j.jaip.2017.04.024
Patel GB, Peters AT. The Role of Biologics in Chronic Rhinosinusitis With Nasal Polyps. Ear Nose Throat J. 2021;100(1):44-47. https://doi.org/10.1177/0145561320964653
Agache I, Song Y, Alonso-Coello P, Vogel Y, Rocha C, Solà I, et al. Efficacy and safety of treatment with biologicals for severe chronic rhinosinusitis with nasal polyps: A systematic review for the EAACI guidelines. Allergy. 2021;76(8):2337-2353. https://doi.org/10.1111/all.14809
Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, et al. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021;3(3):CD013513. https://doi.org/10.1002/14651858.CD013513.pub3
Oykhman P, Paramo FA, Bousquet J, Kennedy DW, Brignardello-Petersen R, Chu DK. Comparative efficacy and safety of monoclonal antibodies and aspirin desensitization for chronic rhinosinusitis with nasal polyposis: A systematic review and network meta-analysis. J Allergy Clin Immunol. 2022;149(4):1286–95. http://dx.doi.org/10.1016/j.jaci.2021.09.009
Papacharalampous GX, Constantinidis J, Fotiadis G, Zhang N, Bachert C, Katotomichelakis M. Chronic rhinosinusitis with nasal polyps (CRSwNP) treated with omalizumab, dupilumab, or mepolizumab: A systematic review of the current knowledge towards an attempt to compare agents' efficacy. Int Forum Allergy Rhinol. 2024;14(1):96-109. https://doi.org/10.1002/alr.23234
Haxel BR, Hummel T, Fruth K, Lorenz K, Gunder N, Nahrath P, Cuevas M. Real-world-effectiveness of biological treatment for severe chronic rhinosinusitis with nasal polyps. Rhinology. 2022;60(6):435-443. https://doi.org/10.4193/Rhin22.129
Tiotiu A, Mendez-Brea P, Ioan I, Romero-Fernandez R, Oster JP, Hoang TC, et al. Real-Life Effectiveness of Benralizumab, Mepolizumab and Omalizumab in Severe Allergic Asthma Associated with Nasal Polyps. Clin Rev Allergy Immunol. 2023;64(2):179-192. https://doi.org/10.1007/s12016-022-08938-w
Gerstacker K, Ketterer MC, Jakob TF, Hildenbrand T. Real Life Observational Study of Treatment Success of Monoclonal Antibodies for Refractory Chronic Rhinosinusitis with Nasal Polyps. J Clin Med. 2023;12(13):4374. https://doi.org/10.3390/jcm12134374
Detoraki A, Tremante E, D'Amato M, Calabrese C, Casella C, Maniscalco M, et al. Mepolizumab improves sino-nasal symptoms and asthma control in severe eosinophilic asthma patients with chronic rhinosinusitis and nasal polyps: a 12-month real-life study. Ther Adv Respir Dis. 2021;15. https://doi.org/10.1177/17534666211009398
Domínguez-Sosa MS, Cabrera-Ramírez MS, Marrero-Ramos MDC, Dávila-Quintana D, Cabrera-López C, Carrillo-Díaz T, et al. Real-Life Effectiveness of Mepolizumab in Refractory Chronic Rhinosinusitis with Nasal Polyps. Biomedicines. 2023;11(2):485. https://doi.org/10.3390/biomedicines11020485
Kilty SJ, Lasso A. Canadian real-world study of access and clinical results using dupilumab for chronic rhinosinusitis with polyps. J Otolaryngol Head Neck Surg. 2022;51(1):17. https://doi.org/10.1186/s40463-022-00570-0
Book R, Eligal S, Tal Y, Eliashar R. Biological Treatment for Uncontrolled Chronic Rhinosinusitis with Nasal Polyps: Preliminary Real-World Results from a Tertiary Medical Center. J Clin Med. 2023;12(11):3671. https://doi.org/10.3390/jcm12113671
Boscke R, Heidemann M, Bruchhage KL. Dupilumab for chronic rhinosinusitis with nasal polyps: real-life retrospective 12-month effectiveness data. Rhinology. 2023;61(3):203-213. https://doi.org/10.4193/Rhin22.469
Albrecht T, Sailer MM, Capitani F, van Schaik C, Löwenheim H, Becker S. Real-world evidence for the effectiveness and safety of dupilumab in patients with CRSwNP after 1 year of therapy. World Allergy Organ J. 2023;16(5):100780. https://doi.org/10.1016/j.waojou.2023.100780
Mocellin D, Ioppi A, Gaglio G, Pennacchi A, Bertolini M, Tirrito A, et al. Severe chronic rhinosinusitis treated with dupilumab, a real-life analysis of early effectiveness. Eur Rev Med Pharmacol Sci. 2023;27(15):7324-7336. https://doi.org/10.26355/eurrev_202308_33304
La Mantia I, Grigaliute E, Ragusa M, Cocuzza S, Radulesco T, Saibene AM, et al. Effectiveness and rapidity on olfatory fuction recovery in CRS patients treated with Dupilumab: a real life prospective controlled study. Eur Arch Otorhinolaryngol. 2024;281:219-226. https://doi.org/10.1007/s00405-023-08184-6
Campion NJ, Brugger J, Tu A, Stanek V, Brkic FF, Bartosik TJ, Liu DT, et al. The "real life" efficacy of dupilumab is independent of initial polyp size and concomitant steroids in CRSwNP. J Otolaryngol Head Neck Surg. 2023;52(1):56. https://doi.org/10.1186/s40463-023-00663-4
De Corso E, Pasquini E, Trimarchi M, La Mantia I, Pagella F, Ottaviano G, et al. Dupireal Italian Study Group. Dupilumab in the treatment of severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP): A multicentric observational Phase IV real-life study (DUPIREAL). Allergy. 2023;78(10):2669-2683. https://doi.org/10.1111/all.15772
Galletti C, Ragusa M, Sireci F, Ciodaro F, Barbieri MA, Giunta G, et al. Dupilumab in chronic rhinosinusitis with nasal polyps: Real life data in a multicentric Sicilian experience. Am J Otolaryngol. 2023;45(1):104106. https://doi.org/10.1016/j.amjoto.2023.104106
Maza-Solano J, Callejon-Leblic A, Martin-Jimenez D, Moreno-Luna R, Gonzalez-Garcia J, Cuvillo A, et al. Omalizumab Treatment in Uncontrolled Asthma and CRSwNP Patients, with Previous Endoscopic Sinus Surgery, to Improve Quality of Life and Endoscopic Outcomes: a Two-Year Real-Life Study. Curr Allergy Asthma Rep. 2023;23(10):555-566. https://doi.org/10.1007/s11882-023-01106-w
Brkic FF, Liu DT, Klimbacher R, Campion NJ, Bartosik TJ, Vyskocil E, et al. Efficacy and safety of switching between biologics in chronic rhinosinusitis with nasal polyps or N-ERD. Rhinology. 2023;61(4):320-327. https://doi.org/10.4193/Rhin22.408
Nagase H, Suzukawa M, Oishi K, Matsunaga K. Biologics for severe asthma: The real-world evidence, effectiveness of switching, and prediction factors for the efficacy. Allergol Int. 2023;72(1):11-23. https://doi.org/10.1016/j.alit.2022.11.008
Alobid I, Colás C, Castillo JA, Arismendi E, Del Cuvillo A, Gómez-Outes A, et al. POLINA group. Spanish Consensus on the Management of Chronic Rhinosinusitis With Nasal Polyps (POLIposis NAsal/POLINA 2.0). J Investig Allergol Clin Immunol. 2023;33(5):317-331. https://doi.org/10.18176/jiaci.0910
Fokkens WJ, Lund V, Bachert C, Mullol J, Bjermer L, Bousquet J, 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
Bachert C, Desrosiers MY, Hellings PW, Laidlaw TM. The Role of Biologics in Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2021;9(3):1099-1106. https://doi.org/10.1016/j.jaip.2020.11.017
Bachert C. Biologics in chronic rhinosinusitis with nasal polyps. Zhang L, Bachert C, editors. Chronic Rhinosinusitis: The Mucosal Concept. Springer Nature Singapore. 2022:411-21.
Borish L, Cohen NA, Chupp G, Hopkins C, Wagenmann M, Sousa AR, et al. Evaluating enrollment and outcome criteria in trials of biologics for chronic rhinosinusitis with nasal polyps. Ann Allergy Asthma Immunol. 2022;129(2):160-168. https://doi.org/10.1016/j.anai.2022.04.004
Bachert C, Han JK, Desrosiers M, Hellings PW, Amin N, Lee SE, 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
Gevaert P, Omachi TA, Corren J, Mullol J, Han J, Lee SE, et al. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials. J Allergy Clin Immunol. 2020; 146(3):595-605. https://doi.org/10.1016/j.jaci.2020.05.032
Han JK, Bachert C, Fokkens W, Desrosiers M, Wagenmann M, Lee SE, et al. SYNAPSE study investigators. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021; 9(10):1141-1153. https://doi.org/10.1016/S2213-2600(21)00097-7
Bachert C, Gevaert P, Hellings P. Biotherapeutics in Chronic Rhinosinusitis with and without Nasal Polyps. J Allergy Clin Immunol Pract. 2017;5(6):1512-1516. https://doi.org/10.1016/j.jaip.2017.04.024
Patel GB, Peters AT. The Role of Biologics in Chronic Rhinosinusitis With Nasal Polyps. Ear Nose Throat J. 2021;100(1):44-47. https://doi.org/10.1177/0145561320964653
Agache I, Song Y, Alonso-Coello P, Vogel Y, Rocha C, Solà I, et al. Efficacy and safety of treatment with biologicals for severe chronic rhinosinusitis with nasal polyps: A systematic review for the EAACI guidelines. Allergy. 2021;76(8):2337-2353. https://doi.org/10.1111/all.14809
Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, et al. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021;3(3):CD013513. https://doi.org/10.1002/14651858.CD013513.pub3
Oykhman P, Paramo FA, Bousquet J, Kennedy DW, Brignardello-Petersen R, Chu DK. Comparative efficacy and safety of monoclonal antibodies and aspirin desensitization for chronic rhinosinusitis with nasal polyposis: A systematic review and network meta-analysis. J Allergy Clin Immunol. 2022;149(4):1286–95. http://dx.doi.org/10.1016/j.jaci.2021.09.009
Papacharalampous GX, Constantinidis J, Fotiadis G, Zhang N, Bachert C, Katotomichelakis M. Chronic rhinosinusitis with nasal polyps (CRSwNP) treated with omalizumab, dupilumab, or mepolizumab: A systematic review of the current knowledge towards an attempt to compare agents' efficacy. Int Forum Allergy Rhinol. 2024;14(1):96-109. https://doi.org/10.1002/alr.23234
Haxel BR, Hummel T, Fruth K, Lorenz K, Gunder N, Nahrath P, Cuevas M. Real-world-effectiveness of biological treatment for severe chronic rhinosinusitis with nasal polyps. Rhinology. 2022;60(6):435-443. https://doi.org/10.4193/Rhin22.129
Tiotiu A, Mendez-Brea P, Ioan I, Romero-Fernandez R, Oster JP, Hoang TC, et al. Real-Life Effectiveness of Benralizumab, Mepolizumab and Omalizumab in Severe Allergic Asthma Associated with Nasal Polyps. Clin Rev Allergy Immunol. 2023;64(2):179-192. https://doi.org/10.1007/s12016-022-08938-w
Gerstacker K, Ketterer MC, Jakob TF, Hildenbrand T. Real Life Observational Study of Treatment Success of Monoclonal Antibodies for Refractory Chronic Rhinosinusitis with Nasal Polyps. J Clin Med. 2023;12(13):4374. https://doi.org/10.3390/jcm12134374
Detoraki A, Tremante E, D'Amato M, Calabrese C, Casella C, Maniscalco M, et al. Mepolizumab improves sino-nasal symptoms and asthma control in severe eosinophilic asthma patients with chronic rhinosinusitis and nasal polyps: a 12-month real-life study. Ther Adv Respir Dis. 2021;15. https://doi.org/10.1177/17534666211009398
Domínguez-Sosa MS, Cabrera-Ramírez MS, Marrero-Ramos MDC, Dávila-Quintana D, Cabrera-López C, Carrillo-Díaz T, et al. Real-Life Effectiveness of Mepolizumab in Refractory Chronic Rhinosinusitis with Nasal Polyps. Biomedicines. 2023;11(2):485. https://doi.org/10.3390/biomedicines11020485
Kilty SJ, Lasso A. Canadian real-world study of access and clinical results using dupilumab for chronic rhinosinusitis with polyps. J Otolaryngol Head Neck Surg. 2022;51(1):17. https://doi.org/10.1186/s40463-022-00570-0
Book R, Eligal S, Tal Y, Eliashar R. Biological Treatment for Uncontrolled Chronic Rhinosinusitis with Nasal Polyps: Preliminary Real-World Results from a Tertiary Medical Center. J Clin Med. 2023;12(11):3671. https://doi.org/10.3390/jcm12113671
Boscke R, Heidemann M, Bruchhage KL. Dupilumab for chronic rhinosinusitis with nasal polyps: real-life retrospective 12-month effectiveness data. Rhinology. 2023;61(3):203-213. https://doi.org/10.4193/Rhin22.469
Albrecht T, Sailer MM, Capitani F, van Schaik C, Löwenheim H, Becker S. Real-world evidence for the effectiveness and safety of dupilumab in patients with CRSwNP after 1 year of therapy. World Allergy Organ J. 2023;16(5):100780. https://doi.org/10.1016/j.waojou.2023.100780
Mocellin D, Ioppi A, Gaglio G, Pennacchi A, Bertolini M, Tirrito A, et al. Severe chronic rhinosinusitis treated with dupilumab, a real-life analysis of early effectiveness. Eur Rev Med Pharmacol Sci. 2023;27(15):7324-7336. https://doi.org/10.26355/eurrev_202308_33304
La Mantia I, Grigaliute E, Ragusa M, Cocuzza S, Radulesco T, Saibene AM, et al. Effectiveness and rapidity on olfatory fuction recovery in CRS patients treated with Dupilumab: a real life prospective controlled study. Eur Arch Otorhinolaryngol. 2024;281:219-226. https://doi.org/10.1007/s00405-023-08184-6
Campion NJ, Brugger J, Tu A, Stanek V, Brkic FF, Bartosik TJ, Liu DT, et al. The "real life" efficacy of dupilumab is independent of initial polyp size and concomitant steroids in CRSwNP. J Otolaryngol Head Neck Surg. 2023;52(1):56. https://doi.org/10.1186/s40463-023-00663-4
De Corso E, Pasquini E, Trimarchi M, La Mantia I, Pagella F, Ottaviano G, et al. Dupireal Italian Study Group. Dupilumab in the treatment of severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP): A multicentric observational Phase IV real-life study (DUPIREAL). Allergy. 2023;78(10):2669-2683. https://doi.org/10.1111/all.15772
Galletti C, Ragusa M, Sireci F, Ciodaro F, Barbieri MA, Giunta G, et al. Dupilumab in chronic rhinosinusitis with nasal polyps: Real life data in a multicentric Sicilian experience. Am J Otolaryngol. 2023;45(1):104106. https://doi.org/10.1016/j.amjoto.2023.104106
Maza-Solano J, Callejon-Leblic A, Martin-Jimenez D, Moreno-Luna R, Gonzalez-Garcia J, Cuvillo A, et al. Omalizumab Treatment in Uncontrolled Asthma and CRSwNP Patients, with Previous Endoscopic Sinus Surgery, to Improve Quality of Life and Endoscopic Outcomes: a Two-Year Real-Life Study. Curr Allergy Asthma Rep. 2023;23(10):555-566. https://doi.org/10.1007/s11882-023-01106-w
Brkic FF, Liu DT, Klimbacher R, Campion NJ, Bartosik TJ, Vyskocil E, et al. Efficacy and safety of switching between biologics in chronic rhinosinusitis with nasal polyps or N-ERD. Rhinology. 2023;61(4):320-327. https://doi.org/10.4193/Rhin22.408
Nagase H, Suzukawa M, Oishi K, Matsunaga K. Biologics for severe asthma: The real-world evidence, effectiveness of switching, and prediction factors for the efficacy. Allergol Int. 2023;72(1):11-23. https://doi.org/10.1016/j.alit.2022.11.008
García-García, C., Villarreal-Patiño, I., Pardo-Maza, A., Bosco-Morales, G., Miranda-Sánchez, E., & Plaza-Mayor, G. (2024). Real life effectiveness of biologics in the treatment of patients with chronic rhinosinusitis with nasosinusal polyposis. Revista ORL, 15(2), e31902. https://doi.org/10.14201/orl.31902
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