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| LETTER TO EDITOR |
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| Year : 2020 | Volume
: 22
| Issue : 2 | Page : 93-94 |
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The use of biologics in chronic rhinosinusitis with polyps: Saudi otorhinolaryngology society position statement
Saad Alsaleh1, Abdulaziz Alqahtani2, Naif H Alotaibi3, Fahad Alfawwaz2, Mohammad Aloulah1, Mai Almasoud4, Mohammad H Al-Bar5, Ali Alzarei6, Osama Marglani7, Saad M Asiri8
1 Saudi Otorhinolaryngology Society Rhinology Committee; Department of Otolaryngology-Head and Neck Surgery, College of Medicine, King Saud University, Riyadh, Saudi Arabia
2 Department of Otolaryngology Head and Neck Surgery, King Fahad Medical City, Riyadh, Saudi Arabia
3 Department of Surgery, College of Medicine, Alfaisal University, Riyadh, Saudi Arabia
4 Department of Otolaryngology Head and Neck Surgery, King Fahad Military Medical Complex, Dhahran, Saudi Arabia
5 Department of Otolaryngology Head and Neck Surgery, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia
6 Department of Otolaryngology Head and Neck Surgery, King Khalid University, Aseer Central Hospital, Abha, Saudi Arabia
7 Department of Otolaryngology Head and Neck Surgery, Umm Al-Qura University, Makkah, Saudi Arabia
8 Department of Otolaryngology Head and Neck Surgery, College of Medicine, Almaarefa University, Riyadh, Saudi Arabia
| Date of Submission | 16-Jun-2020 |
| Date of Acceptance | 21-Jun-2020 |
| Date of Web Publication | 30-Dec-2020 |
Correspondence Address:
Dr. Saad Alsaleh
Department of Otolaryngology-Head and Neck Surgery, College of Medicine, King Saud University, Riyadh 11411
Saudi Arabia
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/SJOH.SJOH_29_20
How to cite this article:
Alsaleh S, Alqahtani A, Alotaibi NH, Alfawwaz F, Aloulah M, Almasoud M, Al-Bar MH, Alzarei A, Marglani O, Asiri SM. The use of biologics in chronic rhinosinusitis with polyps: Saudi otorhinolaryngology society position statement. Saudi J Otorhinolaryngol Head Neck Surg 2020;22:93-4 |
How to cite this URL:
Alsaleh S, Alqahtani A, Alotaibi NH, Alfawwaz F, Aloulah M, Almasoud M, Al-Bar MH, Alzarei A, Marglani O, Asiri SM. The use of biologics in chronic rhinosinusitis with polyps: Saudi otorhinolaryngology society position statement. Saudi J Otorhinolaryngol Head Neck Surg [serial online] 2020 [cited 2022 Oct 7];22:93-4. Available from: https://www.sjohns.org/text.asp?2020/22/2/93/305464 |
Chronic rhinosinusitis (CRS) has conventionally been classified into CRS with nasal polyps (CRSwNP) and CRS without nasal polyps.[1] However, this simplistic approach to a vastly heterogeneous disease was recently replaced with an endotype-driven classification to better manage this diverse pathology.[2] Difficulty in controlling inflammation and disease recurrence despite appropriate medical and surgical management remains a challenge in certain patients afflicted with CRS. CRSwNP with severe eosinophilic Th2-driven inflammation (elevated levels of interleukin-4 (IL-4), IL-5, IL-10, IL-13, eosinophil cationic protein, and immunoglobulin E [IgE]) has been identified as a disease subset associated with these poor outcomes.[3],[4]
In an effort to find alternative therapeutic strategies targeting Th2 inflammatory cytokines, biological therapy with monoclonal antibodies has been introduced in numerous disease entities, such as asthma and atopic dermatitis, among others.[5],[6] Dupilumab (anti-IL-4Rα), mepolizumab (anti-IL-5), and omalizumab (anti-IgE) are the biologic agents investigated in CRSwNP patients with positive outcomes.[7] Dupilumab is the first drug approved by the US Food and Drug Administration to treat adults with CRSwNP. Three randomized clinical trials conducted by the same group of investigators demonstrated the efficacy and safety of the drug.[8],[9] In addition, the drug showed the ability to reduce local type 2 proinflammatory biomarkers and improve the health-related quality of life in adult patients with CRSwNP.[10],[11] To date, the long-term safety and outcomes of the drug in CRSwNP cases have not been reported. The cost-effectiveness of such new therapeutic agents should be considered and is still being investigated because of its significant long-term economic impact on any health-care system. A recent study has demonstrated that endoscopic sinus surgery is more cost-effective than dupilumab for patients with CRSwNP regardless of the number of revision surgeries.[12]
The Saudi Otorhinolaryngology Society endorses the use of the 2020 European position paper on rhinosinusitis and nasal polyps (EPOS) indications of biological therapy in CRSwNP [Table 1] until further national studies are available.[2] It is important to note that the prescription of biologics in eosinophilic CRSwNP patients to be considered after failure of appropriate medical and surgical therapy and not prior unless exceptional circumstances exist [Table 1]. The prescription of biologics for recalcitrant eosinophilic CRSwNP should ideally be considered in a multidisciplinary team approach that involves the rhinologist, pulmonologist, and preferably, an immunologist. The rhinologist should assess responsiveness to biologics based on the EPOS 2020 criteria [Table 2] and ensure the safety of continued long-term usage in every patient. The above statement will be reviewed regularly and updated, as necessary. | Table 1: Indications of biological treatment in chronic rhinosinusitis, as proposed in EPOS 2020
Click here to view |
 | Table 2: Response criteria for biologicals in the treatment of CRS as proposed in EPOS2020[2]
Click here to view |
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
| References | |  |
| 1. | Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, et al. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology 2012;50:1-2.  |
| 2. | 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;58:1-464. |
| 3. | Tomassen P, Vandeplas G, Van Zele T, Cardell LO, Arebro J, Olze H, et al. Inflammatory endotypes of chronic rhinosinusitis based on cluster analysis of biomarkers. J Allergy Clin Immunol 2016;137:1449-560000. |
| 4. | Liao B, Liu JX, Li ZY, Zhen Z, Cao PP, Yao Y, et al. Multidimensional endotypes of chronic rhinosinusitis and their association with treatment outcomes. Allergy 2018;73:1459-69. |
| 5. | Snast I, Reiter O, Hodak E, Friedland R, Mimouni D, Leshem YA. Are biologics efficacious in atopic dermatitis? A systematic review and meta-analysis. Am J Clin Dermatol 2018;19:145-65. |
| 6. | McGregor MC, Krings JG, Nair P, Castro M. Role of biologics in asthma. Am J Respir Crit Care Med 2019;199:433-45. |
| 7. | Chong LY, Piromchai P, Sharp S, Snidvongs K, Philpott C, Hopkins C, et al. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev 2020;2:CD013513. |
| 8. | 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;394:1638-50. |
| 9. | Bachert C, Mannent L, Naclerio RM, Mullol J, Ferguson BJ, Gevaert P, et al. Effect of subcutaneous dupilumab on nasal polyp burden in patients with chronic sinusitis and nasal polyposis: A randomized clinical trial. JAMA 2016;315:469-79. |
| 10. | Jonstam K, Swanson BN, Mannent LP, Cardell LO, Tian N, Wang Y, et al. Dupilumab reduces local type 2 pro-inflammatory biomarkers in chronic rhinosinusitis with nasal polyposis. Allergy 2019;74:743-52. |
| 11. | Bachert C, Hellings PW, Mullol J, Hamilos DL, Gevaert P, Naclerio RM, et al. Dupilumab improves health-related quality of life in patients with chronic rhinosinusitis with nasal polyposis. Allergy 2020;75:148-57. |
| 12. | Scangas GA, Wu AW, Ting JY, Metson R, Walgama E, Shrime MG, et al. Cost utility analysis of dupilumab versus endoscopic sinus surgery for chronic rhinosinusitis with nasal polyps. Laryngoscope 2020;1-8. doi:10.1002/lary.28648. |
[Table 1], [Table 2]
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