Efectividad real de la terapia biológica en el tratamiento de pacientes con rinosinusitis crónica con poliposis nasosinusal
Resumen Introducción y objetivo: El tratamiento de la rinosinusitis crónica con poliposis nasosinusal (RSCcPN) se basa en el uso de corticoterapia local intranasal, ciclos de corticoides sistémicos y cirugía endoscópica nasal. La terapia biológica está ganando cada vez más protagonismo en el tratamiento de esta patología en casos resistentes al tratamiento cásico. El objetivo de este trabajo es determinar la efectividad real de los tratamientos biológicos administrados para la RScPN fuera del ámbito de los ensayos clínicos. Método: Estudio retrospectivo sobre pacientes con RSCcPN y asma en tratamiento con terapia biológica en un hospital universitario. Analizaremos mediante un estudio de Wilcoxon signed-rank la eficacia de los distintos tratamientos biológicos administrados. Resultados: La muestra incluyó 21 pacientes con un seguimiento mínimo de 24 meses. Se evidenció una significación estadistica (p = <0, 001) en cuanto a la mejoría de la sintomatología, a excepción del olfato, así como de una mejoría del Nasal Polyp Score, el SNOT-22 y la escala Lund-Mackay en la TC. De los 21 pacientes, 7 de ellos (33%) han necesitado rescates con tratamiento corticoideo a nivel sistémico. Sin embargo, no hubo que realizar una nueva CENS en ninguno de ellos. Discusión: Los datos obtenidos en este estudio de efectividad en práctica clínica real concuerdan con los obtenidos en ensayos clínicos acerca de la terapia biológica en la RSCcPN. Se han documentado reducciones notables en la carga de enfermedad de RSCcPN de forma objetiva y subjetiva, así como menor necesidad de rescate corticoideo oral o cirugía. Conclusiones: En nuestro estudio se ha corroborado la eficacia de la terapia biológica en prácticamente todos los datos analizados. Sin embargo, no se ha conseguido demostrar la relevancia de un tipo de terapia respecto a otra.
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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
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). Efectividad real de la terapia biológica en el tratamiento de pacientes con rinosinusitis crónica con poliposis nasosinusal. Revista ORL, 15(2), e31902. https://doi.org/10.14201/orl.31902
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