Reduced need for surgery in severe nasal polyposis with mepolizumab: Randomized trial

Journal of Allergy and Clinical Immunology

Volumn 140, Issue 4, 2017, Pages 1024-1031.e14

  Bachert, Claus ^a,b   Sousa, Ana R ^c   Lund, Valerie J ^d   Scadding, Glenis K ^d   Gevaert, Philippe ^a   Nasser, Shuaib ^e   Durham, Stephen R ^f   Cornet, Marjolein E ^g   Kariyawasam, Harsha H ^d   Gilbert, Jane ^c   Austin, Daren ^c   Maxwell, Aoife C ^c   Marshall, Richard P ^c   Fokkens, Wytske J ^g  

^a GHENT UNIVERSITY HOSPITAL   (Belgium)

^b STOCKHOLM UNIVERSITY   (Sweden)

^c GLAXOSMITHKLINE   (United Kingdom)

^d ROYAL NATIONAL THROAT NOSE AND EAR HOSPITAL   (United Kingdom)

^e CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^f NATIONAL HEART AND LUNG INSTITUTE   (United Kingdom)

^g ACADEMIC MEDICAL CENTER   (Netherlands)

Author keywords

chronic rhinosinusitis; eosinophil; IL 5; mepolizumab; Nasal polyposis

Indexed keywords

CORTICOSTEROID; MEPOLIZUMAB; PLACEBO; INTERLEUKIN 5; MONOCLONAL ANTIBODY;

ADD ON THERAPY; ADULT; AGED; ARTHRALGIA; ARTICLE; ASTHMA; BACKACHE; CLINICAL CHEMISTRY; CONTROLLED STUDY; CORTICOSTEROID THERAPY; COUGHING; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG CLEARANCE; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; DYSPNEA; EOSINOPHIL COUNT; EPISTAXIS; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; INFLUENZA; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MAXIMUM CONCENTRATION; MULTICENTER STUDY; NAUSEA; NOSE POLYP; OROPHARYNX PAIN; OTALGIA; PATIENT-REPORTED OUTCOME; POST HOC ANALYSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SMELLING; SYMPTOM ASSESSMENT; VISUAL ANALOG SCALE; VITAL SIGN; VOLUME OF DISTRIBUTION; ADOLESCENT; DISEASE COURSE; ENDOSCOPY; EOSINOPHIL; IMMUNOLOGY; IMMUNOTHERAPY; MIDDLE AGED; NASAL POLYPS; PROCEDURES; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; DISEASE PROGRESSION; ENDOSCOPY; EOSINOPHILS; FEMALE; HUMANS; IMMUNOTHERAPY; INTERLEUKIN-5; MALE; MIDDLE AGED; NASAL POLYPS; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 85026290897     PISSN: 00916749     EISSN: 10976825     Source Type: Journal    
DOI: 10.1016/j.jaci.2017.05.044     Document Type: Article

References (32)

1. Hastan, D., Fokkens, W.J., Bachert, C., Newson, R.B., Bislimovska, J., Bockelbrink, A., et al. Chronic rhinosinusitis in Europe—an underestimated disease. A GA(2)LEN study. Allergy 66 (2011), 1216–1223.
2. Bachert, C., Zhang, L., Gevaert, P., Current and future treatment options for adult chronic rhinosinusitis: focus on nasal polyposis. J Allergy Clin Immunol 136 (2015), 1431–1440.
3. Lange, B., Holst, R., Thilsing, T., Baelum, J., Kjeldsen, A., Quality of life and associated factors in persons with chronic rhinosinusitis in the general population: a prospective questionnaire and clinical cross-sectional study. Clin Otolaryngol 38 (2013), 474–480.
4. Alobid, I., Benitez, P., Bernal-Sprekelsen, M., Roca, J., Alonso, J., Picado, C., et al. Nasal polyposis and its impact on quality of life: comparison between the effects of medical and surgical treatments. Allergy 60 (2005), 452–458.
5. Sahlstrand-Johnson, P., Ohlsson, B., Von Buchwald, C., Jannert, M., Ahlner-Elmqvist, M., A multi-centre study on quality of life and absenteeism in patients with CRS referred for endoscopic surgery. Rhinology 49 (2011), 420–428.
6. Van Zele, T., Gevaert, P., Holtappels, G., Beule, A., Wormald, P.J., Mayr, S., et al. Oral steroids and doxycycline: two different approaches to treat nasal polyps. J Allergy Clin Immunol 125 (2010), 1069–1076.e4.
7. Sharma, R., Lakhani, R., Rimmer, J., Hopkins, C., Surgical interventions for chronic rhinosinusitis with nasal polyps. Cochrane Database Syst Rev(11), 2014, CD006990.
8. Fokkens, W.J., Lund, V.J., Mullol, J., Bachert, C., Alobid, I., Baroody, F., et al. European position paper on rhinosinusitis and nasal polyps 2012. Rhinol Suppl, 3, 2012 preceding table of contents, 1-298.
9. Kalish, L., Snidvongs, K., Sivasubramaniam, R., Cope, D., Harvey, R.J., Topical steroids for nasal polyps. Cochrane Database Syst Rev(12), 2012, CD006549.
10. Martinez-Devesa, P., Patiar, S., Oral steroids for nasal polyps. Cochrane Database Syst Rev(7), 2011, CD005232.
11. Bhattacharyya, N., Orlandi, R.R., Grebner, J., Martinson, M., Cost burden of chronic rhinosinusitis: a claims-based study. Otolaryngol Head Neck Surg 144 (2011), 440–445.
12. Fandino, M., Macdonald, K.I., Lee, J., Witterick, I.J., The use of postoperative topical corticosteroids in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis. Am J Rhinol Allergy 27 (2013), e146–e157.
13. Clutterbuck, E.J., Hirst, E.M., Sanderson, C.J., Human interleukin-5 (IL-5) regulates the production of eosinophils in human bone marrow cultures: comparison and interaction with IL-1, IL-3, IL-6, and GMCSF. Blood 73 (1989), 1504–1512.
14. Mukherjee, M., Sehmi, R., Nair, P., Anti-IL5 therapy for asthma and beyond. World Allergy Organ J, 7, 2014, 32.
15. Gevaert, P., Van Bruaene, N., Cattaert, T., Van Steen, K., Van Zele, T., Acke, F., et al. Mepolizumab, a humanized anti-IL-5 mAb, as a treatment option for severe nasal polyposis. J Allergy Clin Immunol 128 (2011), 989–995 e1-8.
16. Ortega, H.G., Liu, M.C., Pavord, I.D., Brusselle, G.G., FitzGerald, J.M., Chetta, A., et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 371 (2014), 1198–1207.
17. Flood-Page, P.T., Menzies-Gow, A.N., Kay, A.B., Robinson, D.S., Eosinophil's role remains uncertain as anti-interleukin-5 only partially depletes numbers in asthmatic airway. Am J Respir Crit Care Med 167 (2003), 199–204.
18. Bachert, C., Wagenmann, M., Hauser, U., Rudack, C., IL-5 synthesis is upregulated in human nasal polyp tissue. J Allergy Clin Immunol 99 (1997), 837–842.
19. Zhang, N., Van Zele, T., Perez-Novo, C., Van Bruaene, N., Holtappels, G., DeRuyck, N., et al. Different types of T-effector cells orchestrate mucosal inflammation in chronic sinus disease. J Allergy Clin Immunol 122 (2008), 961–968.
20. Tomassen, P., Vandeplas, G., Van Zele, T., Cardell, L.O., Arebro, J., Olze, H., et al. Inflammatory endotypes of chronic rhinosinusitis based on cluster analysis of biomarkers. J Allergy Clin Immunol 137 (2016), 1449–1456.
21. Hamilos, D.L., Leung, D.Y., Huston, D.P., Kamil, A., Wood, R., Hamid, Q., GM-CSF, IL-5 and RANTES immunoreactivity and mRNA expression in chronic hyperplastic sinusitis with nasal polyposis (NP). Clin Exp Allergy 28 (1998), 1145–1152.
22. Bachert, C., Zhang, N., Holtappels, G., De Lobel, L., van Cauwenberge, P., Liu, S., et al. Presence of IL-5 protein and IgE antibodies to staphylococcal enterotoxins in nasal polyps is associated with comorbid asthma. J Allergy Clin Immunol 126 (2010), 962–968 e1-6.
23. Van Zele, T., Holtappels, G., Gevaert, P., Bachert, C., Differences in initial immunoprofiles between recurrent and nonrecurrent chronic rhinosinusitis with nasal polyps. Am J Rhinol Allergy 28 (2014), 192–198.
24. Gevaert, P., Lang-Loidolt, D., Lackner, A., Stammberger, H., Staudinger, H., Van Zele, T., et al. Nasal IL-5 levels determine the response to anti-IL-5 treatment in patients with nasal polyps. J Allergy Clin Immunol 118 (2006), 1133–1141.
25. Spiegelhalter, D.J., Abrams, K.R., Myles, J.P., Bayesian approaches to clinical trials and health-care evaluation. 2004, Wiley, West Sussex, United Kingdom.
26. Bonfils, P., Halimi, P., Malinvaud, D., Adrenal suppression and osteoporosis after treatment of nasal polyposis. Acta Otolaryngol 126 (2006), 1195–1200.
27. Bachert, C., Mannent, L., Naclerio, R.M., Mullol, J., Ferguson, B.J., 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 315 (2016), 469–479.
28. Pavord, I.D., Korn, S., Howarth, P., Bleecker, E.R., Buhl, R., Keene, O.N., et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet 380 (2012), 651–659.
29. Bachert, C., Gevaert, P., Holtappels, G., Johansson, S.G., van Cauwenberge, P., Total and specific IgE in nasal polyps is related to local eosinophilic inflammation. J Allergy Clin Immunol 107 (2001), 607–614.
30. Wang, X., Zhang, N., Bo, M., Holtappels, G., Zheng, M., Lou, H., et al. Diversity of T-helper cytokine-profiles in chronic rhinosinusitis: a multicenter study in Europe, Asia and Oceania. J Allergy Clin Immunol 138 (2016), 1344–1353.
31. Bel, E., Wenzel, S., Thompson, P., Prazma, C.M., Keene, O.N., Yancey, S.W., et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 371 (2014), 1189–1197.
32. Varricchi, G., Bagnasco, D., Ferrando, M., Puggioni, F., Passalacqua, G., Canonica, G.W., Mepolizumab in the management of severe eosinophilic asthma in adults: current evidence and practical experience. Ther Adv Respir Dis 11 (2017), 40–45.