Eficacia de la Terapia Biológica (Dupilumab) en Rinosinusitis Crónica con Pólipos Nasales: Revisión Sistemática
Resumen
Introducción: La rinosinusitis crónica con pólipos nasales (RSCcPN) es una enfermedad inflamatoria tipo 2 caracterizada por alta recurrencia y significativa afectación de la calidad de vida. Dupilumab, un anticuerpo monoclonal dirigido contra la señalización de IL-4/IL-13, ha emergido como una opción terapéutica innovadora en pacientes con enfermedad grave o refractaria. Objetivo: Evaluar la eficacia de dupilumab en pacientes con RSCcPN, considerando desenlaces clínicos, calidad de vida, subgrupos específicos y comparaciones terapéuticas. Métodos: Se realizó una revisión sistemática basada en la bibliografía proporcionada, incluyendo ensayos clínicos aleatorizados fase 3, estudios de vida real, revisiones sistemáticas y metaanálisis. Se analizaron desenlaces como tamaño de pólipos nasales (NPS), síntomas nasales, función olfatoria, calidad de vida (SNOT-22), uso de corticosteroides sistémicos y necesidad de cirugía. Resultados: La evidencia muestra que dupilumab reduce significativamente el tamaño de los pólipos nasales, mejora la congestión nasal y la función olfatoria, y disminuye la opacificación sinusal. Asimismo, se asocia con mejoría clínicamente relevante en la calidad de vida, reflejada en reducciones sustanciales del SNOT-22. El tratamiento también reduce la necesidad de corticosteroides sistémicos y cirugía de rescate. Estos beneficios son consistentes en subgrupos clínicos complejos, incluyendo pacientes con asma, NSAID-ERD y antecedentes de cirugía sinusal. En comparaciones terapéuticas, dupilumab muestra ventajas frente a otros biológicos en varios desenlaces, mientras que frente a la cirugía ofrece un control más sostenido de la enfermedad. Conclusiones: Dupilumab es una terapia eficaz y segura para la RSCcPN, con beneficios consistentes en múltiples desenlaces clínicos y funcionales. Su uso debe considerarse dentro de estrategias de tratamiento personalizado, especialmente en pacientes con enfermedad grave o refractaria. Se requieren estudios adicionales para optimizar su posicionamiento terapéutico y evaluar resultados a largo plazo.
Descargas
Citas
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. The Lancet. 2019 Nov;394(10209):1638–50.
Mullol J, Laidlaw TM, Bachert C, Mannent LP, Canonica GW, Han Joseph K, et al. Efficacy and safety of dupilumab in patients with uncontrolled severe CRSwNP and a clinical diagnosis of NSAID‐ERD: Results from two randomized placebo‐controlled phase 3 trials. Allergy. 2021 Oct;
Hopkins C, Han JK, Wytske Fokkens, Wagenmann M, Guyot P, Khan AH, et al. Dupilumab versus mepolizumab for chronic rhinosinusitis with nasal polyposis: an indirect treatment comparison. The Journal of Allergy and Clinical Immunology In Practice. 2024 Sep 1;
Kim J, Kim DH, Hwang SH. Effectiveness of Dupilumab Treatment to Treat Chronic Rhinosinusitis With Nasal Polyposis: A Systematic Review and Meta-Analysis. Journal of Rhinology. 2023 Jul 31;30(2):62–8.
Marco G, Arianna S, Domenico C, Gabriele O, Silvia LM, Giulia Z, et al. Efficacy of Dupilumab in the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP): a multicentric real-life study. European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery [Internet]. 2025 Aug;282(8):4097–107. Available from: https://pubmed.ncbi.nlm.nih.gov/40652138/
Gálvez-Gafo L, Mariño-Sánchez F, Yeguas-Ramírez L, Muñoz-García M, Sánchez-Cuéllar S, Antolín-Amérigo D, et al. Evaluating mepolizumab and dupilumab for severe chronic rhinosinusitis with nasal polyps: insights from a real-life study. Acta otorrinolaringologica española [Internet]. 2026 Spring;512328. Available from: https://pubmed.ncbi.nlm.nih.gov/41730425/
Londoño S, Penagos JC, Díaz D, Cadena P, Rodríguez Ordóñez P. Caracterización clínica y demográfica de pacientes colombianos con rinosinusitis crónica con poliposis nasal. Revista Alergia México. 2024 Apr 23;71(1):77.
De Corso E, Canonica GW, Heffler E, Springer M, Grzegorzek T, Viana M, et al. Dupilumab versus omalizumab in patients with chronic rhinosinusitis with nasal polyps and coexisting asthma (EVEREST): a multicentre, randomised, double-blind, head-to-head phase 4 trial. The Lancet Respiratory Medicine [Internet]. 2025 Sep ]; Available from: https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(25)00287-5/fulltext
Hopkins C, Wagenmann M, Bachert C, Desrosiers M, Han JK, Hellings PW, et al. Efficacy of dupilumab in patients with a history of prior sinus surgery for chronic rhinosinusitis with nasal polyps. International Forum of Allergy & Rhinology. 2021 Feb 21;11(7):1087–101.
Giombi F, Gian Marco Pace, Nappi E, Giunta G, Muci G, Pirola F, et al. Radiological Versus Clinical 1‐Year Outcomes of Dupilumab in Refractory CRSwNP: A Real‐Life Study. The Laryngoscope. 2023 Dec 21;134(6):2626–33.
Bachert C, Khan AH, Fokkens WJ, Hopkins C, Philippe Gevaert, Han JK, et al. Dupilumab response onset, maintenance, and durability in patients with severe CRSwNP. Journal of Allergy and Clinical Immunology. 2024 Aug 1;
Peters AT, Wagenmann M, Bernstein JA, Khan AH, Nash S, Jacob-Nara JA, et al. Dupilumab efficacy in patients with chronic rhinosinusitis with nasal polyps with and without allergic rhinitis. Allergy and Asthma Proceedings. 2023 Jul 1;44(4):265–74.
Koski RR, Hill L, Taavola K. Efficacy and Safety of Biologics for Chronic Rhinosinusitis With Nasal Polyps. Journal of Pharmacy Technology. 2022 Jul 11;875512252211057.
Book R, Lazutkin A, Eliashar R. Long-Term Real-World Outcomes and Insights of Biologic Therapies in Chronic Rhinosinusitis with Nasal Polyps. International Journal of Molecular Sciences. 2025 May 14;26(10):4694.
Kariyawasam HH, James LK, Gane SB. Dupilumab: Clinical Efficacy of Blocking IL-4/IL-13 Signalling in Chronic Rhinosinusitis with Nasal Polyps. Drug Design, Development and Therapy [Internet]. 2020 May 8;14:1757–69. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7217316/
Overview | Dupilumab for treating severe chronic rhinosinusitis with nasal polyps | Guidance | NICE [Internet]. Nice.org.uk. NICE; 2026. Available from: https://www.nice.org.uk/guidance/ta1134
Pfaller B, Bendien S, Ditisheim A, Eiwegger T. Management of allergic diseases in pregnancy. Allergy. 2021 Sep 4;77(3):798–811.
Bachert C, Hellings P, Joaquim Mullol, Hamilos DL, Philippe Gevaert, Naclerio RM, et al. Dupilumab improves health‐related quality of life in patients with chronic rhinosinusitis with nasal polyposis. Allergy. 2019 Oct 23;75(1):148–57.
Cai S, Xu S, Zhao Y, Zhang L. Efficacy and Safety of Biologics for Chronic Rhinosinusitis With Nasal Polyps: A Meta‐Analysis of Real‐World Evidence. Allergy [Internet]. 2025 Feb 22;80(5):1256–70. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC12105074/
Sim L, Md Shukri N, Yaacob NM, Periasamy C, Cornelia MG, Abdullah B. Efficacy and safety of dupilumab in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis. Expert review of clinical pharmacology [Internet]. 2025 Apr;18(4):211–24. Available from: https://pubmed.ncbi.nlm.nih.gov/39960116/
Papacharalampous G, Jannis Constantinidis, 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. International Forum of Allergy & Rhinology. 2023 Jul 18;
Kim DH, Gulnaz Stybayeva, Hwang SH. Comparative Effectiveness of Dupilumab Versus Sinus Surgery for Chronic Rhinosinusitis With Polyps: Systematic Review and a Meta-Analysis. American Journal of Rhinology and Allergy. 2024 Aug 16;38(6):428–36.
María Sandra Domínguez-Sosa, María Soledad Cabrera-Ramírez, Miriam, Dávila-Quintana D, Cabrera-López C, Cuervo HG, et al. Efficacy of dupilumab on chronic rhinosinusitis with nasal polyps and concomitant asthma in biologic-naive and biologic-pretreated patients. Annals of Medicine. 2024 Oct 4;56(1).
Huber P, Gröger M, Stihl C, Frankenberger H, Gellrich D. Evolving trends in dupilumab use for chronic rhinosinusitis with nasal polyps (CRSwNP): a 4-year cohort analysis. Scientific reports [Internet]. 2025;15(1):44338. Available from: https://pubmed.ncbi.nlm.nih.gov/41413070/
Hoy SM. Dupilumab: A Review in Chronic Rhinosinusitis with Nasal Polyps. Drugs [Internet]. 2020 Apr 2 [cited 2026 Apr 15];80(7):711–7. Available from: https://pubmed.ncbi.nlm.nih.gov/32240527/
Deng M, Fu R, Lv M, Feng Y. Dupilumab for Chronic Rhinosinusitis with Primary Nasal Polyps: a Case Report and Literature Review. Journal of Inflammation Research. 2025 Apr;Volume 18:4607–12.
Rodriguez-Iglesias M, Calvo-Henríquez C, Martin-Jimenez D, Ainhoa García-Lliberós, Maza-Solano J, Moreno-Luna R, et al. Effect of Dupilumab in CRSwNP Sinonasal Outcomes from Real Life Studies: A Systematic Review with Meta-analysis. Current Allergy and Asthma Reports [Internet]. 2025 Feb 5 [cited 2025 Feb 13];25(1). Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC11799128/
Lang, A., Habenbacher, M., Moser, U. et al. Impact of dupilumab on SNOT-22 domain and individual item scores in chronic rhinosinusitis with nasal polyps. Sci Rep 16, 3772 (2026). https://rdcu.be/fdDtx
Seidel, D.U., Busenius, J., Below, M. et al. Prescriptions of biologics in patients with chronic rhinosinusitis with nasal polyps in Germany (2019–2023). Eur Arch Otorhinolaryngol 282, 5711–5720 (2025). https://rdcu.be/fdDud
Ciofalo, A., Loperfido, A., Baroncelli, S. et al. Comparison between clinical and cytological findings in chronic rhinosinusitis with nasal polyps treated with Dupilumab. Eur Arch Otorhinolaryngol 281, 6511–6521 (2024). https://rdcu.be/fdDu0
Derechos de autor 2026 Celina Nicole Angulo Salgado, Vivian Paulette Tágano Perón , Guillermo Hernández Morales , Miguel Ángel Michimani Medina, Anette Joseline Caballero Lucero , Maria Alexandra Argüelles Ríos, Lomeli Poblete Marin, Ana Sofía Sánchez Soto, Diego Franco Rojas , Valentina Eleonora Osorio Tapia
Esta obra está bajo licencia internacional Creative Commons Reconocimiento 4.0.
.png)
.png)
1.png)
