Clinical evaluation protocol for chronic rhinosinusitis with polyposis during treatment with biological agents
DOI:
https://doi.org/10.34631/sporl.2038Keywords:
Chronic rhinosinusitis with polyposis, Biological Agents, Clinical ProtocolAbstract
Introduction: Chronic rhinosinusitis with nasal polyposis is a common pathology in Otorhinolaryngology, and the therapeutic options, in a simplified way, are medical and/or surgical. Medical therapeutic options, in addition to topical and oral corticosteroid therapy, include the use of biological agents. Three biological agents were recently approved for the treatment of chronic rhinosinusitis with nasal polyposis in Portugal, being indicated in critically ill patients not controlled with topical nasal corticosteroid therapy, for whom surgery (unless contraindicated) and/or systemic corticosteroid therapy did not provide adequate control of the disease.
Objectives: To propose a clinical evaluation protocol in patients under biological treatment.
Methods: Review of relevant medical literature, namely the two main international working groups on this topic: European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS) and European Forum for Research and Education in Allergy and Airway Diseases (EUFOREA).
Results: The protocol created can be divided into 3 phases: an initial phase with collection of demographic and clinical data, a second phase with evaluation of eligibility for biologicals based on well-defined admission criteria and a third phase with a proposal of follow-up and application of efficacy and discontinuation criteria.
Conclusion: This clinical protocol presents a proposition for the collection of standardized data to be used in clinical practice, which allows a uniform collection for carrying out prospective and/or retrospective multicenter studies, in addition to a proposition for follow-up and evaluation of the efficacy/failure of the treatment with biological agents, in patients with chronic rhinosinusitis with polyposis.
References
Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S. et al. European position paper on rhinosinusitis and nasal polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.
Abreu NA, Nagalingam NA, Song Y, Roediger FC, Pletcher SD, Goldberg NA. et al. Sinus microbiome diversity depletion and Corynebacterium tuberculostearicum enrichment mediates rhinosinusitis. Sci Transl Med. 2012 Sep 12;4(151):151ra124. doi: 10.1126/scitranslmed.3003783.
Gan W, Yang F, Tang Y, Zhou D, Qing D, Hu J. et al. The difference in nasal bacterial microbiome diver- sity between chronic rhinosinusitis patients with polyps and a control population. Int Forum Allergy Rhinol. 2019 Jun;9(6):582-592.doi: 10.1002/alr.22297.
Lee K, Pletcher SD, Lynch SV, Goldberg AN, Cope EK. Heterogeneity of microbiota dysbiosis in chronic rhinosinusitis: potential clinical implications and microbial community mechanisms contributing to sinonasal inflammation. Front Cell Infect Microbiol. 2018 May 23;8:168. doi: 10.3389/fcimb.2018.00168.
Copeland E, Leonard K, Carney R, Kong J, Forer M, Naidoo Y. et al. Chronic rhinosinusitis: potential role of microbial dysbiosis and recommendations for sampling sites. Front Cell Infect Microbiol 2018 Feb 28;8:57. doi: 10.3389/fcimb.2018.00057.
Zhao YC, Bassiouni A, Tanjararak K, Vreugde S, Wormald PJ, Psaltis AJ. Role of fungi in chronic rhinosinusitis through ITS sequencing. Laryngoscope. 2018 Jan;128(1):16-22. doi: 10.1002/lary.26702.
Hoggard M, Biswas K, Zoing M, Wagner Mackenzie B, Taylor MW, Douglas RG. Evidence of microbiota dysbiosis in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2017 Mar;7(3):230-239.doi: 10.1002/alr.21871
Karunasagar A, Jalastagi R, Naik A, Rai P. Detection of bacteria by 16S rRNA PCR and sequencing in culture-negative chronic rhinosinusitis. Laryngoscope. 2018 Oct;128(10):2223-2225. doi: 10.1002/lary.27122.
Chalermwatanachai T, Vilchez-Vargas R, Holtappels G, Lacoere T, Jáuregui R, Kerckhof FM. et al. Chronic rhinosinusitis with nasal polyps is characterized by dysbacteriosis of the nasal microbiota. Sci Rep. 2018 May 21;8(1):7926. doi: 10.1038/s41598-018-26327-2.
Lee K, Pletcher SD, Lynch SV, Goldberg AN, Cope EK. Heterogeneity of microbiota dysbiosis in chronic rhinosinusitis: potential clinical implications and microbial community mechanisms contributing to sinonasal inflammation. Front Cell Infect Microbiol. 2018 May 23;8:168. doi: 10.3389/fcimb.2018.00168.
Cheng KJ, Wang SQ, Xu YY. Different roles of Staphylococcus aureus entero- toxin in different subtypes of nasal polyps. Exp Ther Med. 2017 Jan;13(1):321-326. doi: 10.3892/etm.2016.3951
Takeda K, Sakakibara S, Yamashita K, Motooka D, Nakamura S, El Hussien MA. et al. Allergic conversion of protective mucosal immunity against nasal bacteria in patients with chronic rhinosinusitis with nasal polyposis. J Allergy Clin Immunol. 2019 Mar;143(3):1163-1175.e15. doi: 10.1016/j.jaci.2018.07.006.
Tan BK, Li QZ, Suh L, Kato A, Conley DB, Chandra RK. et al. Evidence for intranasal antinuclear autoantibodies in patients with chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol. 2011 Dec;128(6):1198-1206.e1. doi: 10.1016/j.jaci.2011.08.037.
Lan F, Zhang N, Holtappels G, De Ruyck N, Krysko O, Van Crombruggen K. et al. Staphylococcus aureus induces a mucosal type 2 immune response via epithelial cell- derived cytokines. Am J Respir Crit Care Med. 2018 Aug 15;198(4):452-463. doi: 10.1164/rccm.201710-2112OC.
Rudmik L, Soler ZM, Hopkins C, Schlosser RJ, Peters A, White AA. et al. Defining appropriateness criteria for endoscopic sinus surgery during management of uncomplicated adult chronic rhinosinusitis: a RAND/UCLA appropriateness study. Rhinology. 2016 Jun;54(2):117-28. doi: 10.4193/Rhino16.023.
Reitsma S, Adriaensen GFJPM, Cornet ME, van Haastert RM, Raftopulos MH, Fokkens WJ. The Amsterdam Classification of Completeness of Endoscopic Sinus Surgery (ACCESS): a new CT-based scoring system grading the extent of surgery. Rhinology. 2020 Dec 1;58(6):538-543. doi: 10.4193/Rhin20.165.
Zhang L, Zhang Y, Gao Y, Wang K, Lou H, Meng Y. et al. Long-term outcomes of different endoscopic sinus surgery in recurrent chronic rhinosinusitis with nasal polyps and asthma. Rhinology. 2020 Apr 1;58(2):126-135. doi: 10.4193/Rhin19.184.
Delarestaghi MM, Rajaeih S, Firouzabadi FD, Jamali M, Roomiani M, Firouzabadi MD. et al. Evaluation of the effect of endoscopic partial middle turbinectomy surgery on the quality of life of patients with chronic rhinosinusitis and nasal polyps. Rhinology. 2020 Jun 1;58(3):208-212. doi: 10.4193/Rhin19.258.
Easthope S, Jarvis B. Omalizumab. Drugs. 2001;61(2):253-60; discussion 261. doi: 10.2165/00003495-200161020-00008.
Pavord ID, Menzies-Gow A, Buhl R, Chanez P, Dransfield M, Lugogo N. et al. Clinical development of mepolizumab for the treatment of severe eosinophilic asthma: on the path to personalized medicine. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1121-1132.e7. doi: 10.1016/j.jaip.2020.08.039
Gooderham MJ, Hong HC, Eshtiaghi P, Papp KA. Dupilumab: A review of its use in the treatment of atopic dermatitis. J Am Acad Dermatol. 2018 Mar;78(3 Suppl 1):S28-S36. doi: 10.1016/j.jaad.2017.12.022.
Bachert C, Han JK, Wagenmann M, Hosemann W, Lee SE, Backer V. 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 Jan;147(1):29-36. doi: 10.1016/j.jaci.2020.11.013
Gevaert P, Calus L, Van Zele T, Blomme K, De Ruyck N, Bauters W. et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol. 2013 Jan;131(1):110-6.e1. doi: 10.1016/j.jaci.2012.07.047.
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 Nov 2;394(10209):1638-1650. doi: 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 Sep;146(3):595-605. doi: 10.1016/j.jaci.2020.05.032
Han JK, Bachert C, Fokkens W, Desrosiers M, Wagenmann M, Lee SE. et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021 Oct;9(10):1141-1153. doi: 10.1016/S2213-2600(21)00097-7.
Tversky J, Lane AP, Azar A. Benralizumab effect on severe chronic rhinosinusitis with nasal polyps (CRSwNP): a randomized double-blind placebo-controlled trial. Clin Exp Allergy. 2021 Jun;51(6):836-844. doi: 10.1111/cea.13852.
Doty RL, Kamath V. The influences of age on olfaction: a review. Front Psychol. 2014 Feb 7;5:20. doi: 10.3389/fpsyg.2014.00020.
Fokkens W, Lund V, Mullol J. European position paper on rhinosinusitis and nasal polyps 2007. Rhinol Suppl. 2007;20:1-136.
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 Aug;76(8):2337-2353. doi: 10.1111/all.14809
de Vilhena D, Duarte D, Lopes G. Sino-nasal outcome test-22: translation, cultural adaptation and validation in Portugal. Clin Otolaryngol. 2016 Feb;41(1):21-4. doi: 10.1111/coa.12465.
Doulaptsi M, Prokopakis E, Seys S, Pugin B, Steelant B, Hellings P. Visual analogue scale for sino-nasal symptoms severity correlates with sino-nasal outcome test 22: paving the way for a simple outcome tool of CRS burden. Clin Transl Allergy. 2018 Sep 3;8:32. doi: 10.1186/s13601-018-0219-6.
Djupesland PG, Reitsma S, Hopkins C, Sedaghat AR, Peters A, Fokkens WJ. Endoscopic grading systems for nasal polyps: are we comparing apples to oranges? Rhinology. 2022 Apr 11. doi: 10.4193/Rhin21.401
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