Emerging biologics for the treatment of chronic rhinosinusitis

References

• Hamilos DL. Chronic rhinosinusitis: epidemiology and medical management. J Allergy Clin Immunol 2011;128(4):693-707; quiz 8-9
   Google Scholar
• Hastan D, Fokkens WJ, Bachert C, et al. Chronic rhinosinusitis in Europe--an underestimated disease. A GA(2)LEN study. Allergy 2011;66(9):1216-23
   PubMed Web of Science ®Google Scholar
• Fokkens WJ, Lund VJ, Mullol J, et al. EPOS 2012: european position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology 2012;50(1):1-12
   PubMed Web of Science ®Google Scholar
• Bachert C, Pawankar R, Zhang L, et al. ICON: chronic rhinosinusitis. World Allergy Organ J 2014;7(1):25
   PubMedGoogle Scholar
• Bachert C, Zhang N, van Zele T, Gevaert P. Chronic rhinosinusitis: from one disease to different phenotypes. Pediatr Allergy Immunol 2012;23(Suppl 22):2-4
   PubMedGoogle Scholar
• Akdis CA, Bachert C, Cingi C, et al. Endotypes and phenotypes of chronic rhinosinusitis: a PRACTALL document of the European Academy of Allergy and Clinical Immunology and the American Academy of Allergy, Asthma & Immunology. J Allergy Clin Immunol 2013;131(6):1479-90
   PubMed Web of Science ®Google Scholar
• Huvenne W, van Bruaene N, Zhang N, et al. Chronic rhinosinusitis with and without nasal polyps: what is the difference? Curr Allergy Asthma Rep 2009;9(3):213-20
   Google Scholar
• Van Crombruggen K, Zhang N, Gevaert P, et al. Pathogenesis of chronic rhinosinusitis: inflammation. J Allergy Clin Immunol 2011;128(4):728-32
   PubMed Web of Science ®Google Scholar
• Van Zele T, Claeys S, Gevaert P, et al. Differentiation of chronic sinus diseases by measurement of inflammatory mediators. Allergy 2006;61(11):1280-9
   PubMed Web of Science ®Google Scholar
• Simon HU, Yousefi S, Schranz C, et al. Direct demonstration of delayed eosinophil apoptosis as a mechanism causing tissue eosinophilia. J Immuno Baltimore, Md : 1950 1997:158(8):3902-8
   Google Scholar
• Steinke JW. Anti-interleukin-4 therapy. Immunol Allergy Clin North Am 2004;24(4):599-614, vi
   PubMed Web of Science ®Google Scholar
• Gevaert P, Lang-Loidolt D, Lackner A, et al. Nasal IL-5 levels determine the response to anti-IL-5 treatment in patients with nasal polyps. J Allergy Clin Immunol 2006;118(5):1133-41
   PubMed Web of Science ®Google Scholar
• Busse WW, Katial R, Gossage D, et al. Safety profile, pharmacokinetics, and biologic activity of MEDI-563, an anti-IL-5 receptor alpha antibody, in a phase I study of subjects with mild asthma. J Allergy Clin Immunol 2010;125(6):1237-44; e2
   PubMed Web of Science ®Google Scholar
• Hodsman P, Ashman C, Cahn A, et al. A phase 1, randomized, placebo-controlled, dose-escalation study of an anti-IL-13 monoclonal antibody in healthy subjects and mild asthmatics. Br J Clin Pharmacol 2013;75(1):118-28
   PubMed Web of Science ®Google Scholar
• Piper E, Brightling C, Niven R, et al. A phase II placebo-controlled study of tralokinumab in moderate-to-severe asthma. Eur Respir J 2013;41(2):330-8
   PubMed Web of Science ®Google Scholar
• Busse WW, Holgate S, Kerwin E, et al. Randomized, double-blind, placebo-controlled study of brodalumab, a human anti-IL-17 receptor monoclonal antibody, in moderate to severe asthma. Am J Respir Crit Care Med 2013;188(11):1294-302
   PubMed Web of Science ®Google Scholar
• Zhang N, Van Zele T, Perez-Novo C, et al. Different types of T-effector cells orchestrate mucosal inflammation in chronic sinus disease. J Allergy Clin Immunol 2008;122(5):961-8
   PubMed Web of Science ®Google Scholar
• Bachert C, Gevaert P, Holtappels G, et al. Total and specific IgE in nasal polyps is related to local eosinophilic inflammation. J Allergy Clin Immunol 2001;107(4):607-14
   PubMed Web of Science ®Google Scholar
• Kimura S, Pawankar R, Mori S, et al. Increased expression and role of thymic stromal lymphopoietin in nasal polyposis. Allergy Asthma Immunol Res 2011;3(3):186-93
   PubMed Web of Science ®Google Scholar
• Liu T, Li TL, Zhao F, et al. Role of thymic stromal lymphopoietin in the pathogenesis of nasal polyposis. Am J Med Sci 2011;341(1):40-7
   PubMed Web of Science ®Google Scholar
• Gauvreau GM, Boulet LP, Cockcroft DW, et al. OX40L blockade and allergen-induced airway responses in subjects with mild asthma. Clin Exp Allergy 2014;44(1):29-37
   PubMed Web of Science ®Google Scholar
• Gauvreau GM, O’Byrne PM, Boulet LP, et al. Effects of an anti-TSLP antibody on allergen-induced asthmatic responses. N Engl J Med 2014;370(22):2102-10
   PubMed Web of Science ®Google Scholar
• Nagarkar DR, Poposki JA, Tan BK, et al. Thymic stromal lymphopoietin activity is increased in nasal polyps of patients with chronic rhinosinusitis. J Allergy Clin Immunol 2013;132(3):593-600.e12
   PubMed Web of Science ®Google Scholar
• Wenzel SE, Barnes PJ, Bleecker ER, et al. A randomized, double-blind, placebo-controlled study of tumor necrosis factor-alpha blockade in severe persistent asthma. Am J Respir Crit Care Med 2009;179(7):549-58
   PubMed Web of Science ®Google Scholar
• Otto BA, Wenzel SE. The role of cytokines in chronic rhinosinusitis with nasal polyps. Curr Opin Otolaryngol Head Neck Surg 2008;16(3):270-4
   Google Scholar
• Brightling C, Berry M, Amrani Y. Targeting TNF-alpha: a novel therapeutic approach for asthma. J Allergy Clin Immunol 2008;121(1):5-10; quiz 1-2
   PubMed Web of Science ®Google Scholar
• Howarth PH, Babu KS, Arshad HS, et al. Tumour necrosis factor (TNFalpha) as a novel therapeutic target in symptomatic corticosteroid dependent asthma. Thorax 2005;60(12):1012-18
   PubMed Web of Science ®Google Scholar
• Erzurum SC. Inhibition of tumor necrosis factor alpha for refractory asthma. N Engl J Med 2006;354(7):754-8
   PubMed Web of Science ®Google Scholar
• Bachert C, Zhang N, Holtappels G, 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 2010;126(5):962-8; 8 e1-6
   PubMed Web of Science ®Google Scholar
• Lehrer E, Mullol J, Agredo F, Alobid I. Management of chronic rhinosinusitis in asthma patients: is there still a debate? Curr Allergy Asthma Rep 2014;14(6):440
   Google Scholar
• 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 2014;28(3):192-8
   PubMed Web of Science ®Google Scholar
• Berger WE. Treatment of allergic rhinitis and other immunoglobulin E-mediated diseases with anti-immunoglobulin E antibody. Allergy Asthma Proc 2006;27(2 Suppl 1):S29-32
   Google Scholar
• D’Amato G, Stanziola A, Sanduzzi A, et al. Treating severe allergic asthma with anti-IgE monoclonal antibody (omalizumab): a review. Multidiscip Respir Med 2014;9(1):23
   PubMedGoogle Scholar
• MacGlashan DWJr, Bochner BS, Adelman DC, et al. Down-regulation of Fc(epsilon)RI expression on human basophils during in vivo treatment of atopic patients with anti-IgE antibody. J Immunol Baltimore, Md : 1950 1997;158(3):1438-45
   PubMed Web of Science ®Google Scholar
• Prussin C, Griffith DT, Boesel KM, et al. Omalizumab treatment downregulates dendritic cell FcepsilonRI expression. J Allergy Clin Immunol 2003;112(6):1147-54
   PubMed Web of Science ®Google Scholar
• Catley MC, Coote J, Bari M, Tomlinson KL. Monoclonal antibodies for the treatment of asthma. Pharmacol Ther 2011;132(3):333-51
   PubMed Web of Science ®Google Scholar
• Gevaert P, Calus L, Van Zele T, et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol 2013;131(1):110-6.e1
   PubMed Web of Science ®Google Scholar
• Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol 2001;108(2):184-90
   PubMed Web of Science ®Google Scholar
• Casale TB, Condemi J, LaForce C, et al. Effect of omalizumab on symptoms of seasonal allergic rhinitis: a randomized controlled trial. Jama 2001;286(23):2956-67
   PubMed Web of Science ®Google Scholar
• Grundmann SA, Hemfort PB, Luger TA, Brehler R. Anti-IgE (omalizumab): a new therapeutic approach for chronic rhinosinusitis. J Allergy Clin Immunol 2008;121(1):257-8
   Google Scholar
• Vennera Mdel C, Picado C, Mullol J, et al. Efficacy of omalizumab in the treatment of nasal polyps. Thorax 2011;66(9):824-5
   PubMed Web of Science ®Google Scholar
• Holgate ST, Djukanovic R, Casale T, Bousquet J. Anti-immunoglobulin E treatment with omalizumab in allergic diseases: an update on anti-inflammatory activity and clinical efficacy. Clin Exp Allergy 2005;35(4):408-16
   PubMed Web of Science ®Google Scholar
• Pinto JM, Mehta N, DiTineo M, et al. A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis. Rhinology 2010;48(3):318-24
   PubMed Web of Science ®Google Scholar
• Subcutaneous omalizumab for treatment of chronic rhinosinusitis with nasal polyposis (Xolair CRS). Available from: https://clinicaltrials.gov/ct2/show/NCT01066104
   Google Scholar
• Arm JP, Bottoli I, Skerjanec A, et al. Pharmacokinetics, pharmacodynamics and safety of QGE031 (ligelizumab), a novel high-affinity anti-IgE antibody, in atopic subjects. Clin Exp Allergy 2014;44(11):1371-85
   PubMed Web of Science ®Google Scholar
• Brightbill HD, Jeet S, Lin Z, et al. Antibodies specific for a segment of human membrane IgE deplete IgE-producing B cells in humanized mice. J Clin Invest 2010;120(6):2218-29
   Google Scholar
• Gauvreau GM, Harris JM, Boulet LP, et al. Targeting membrane-expressed IgE B cell receptor with an antibody to the M1 prime epitope reduces IgE production. Sci Transl Med 2014;6(243):243ra85
   PubMed Web of Science ®Google Scholar
• Flood-Page P, Swenson C, Faiferman I, et al. A study to evaluate safety and efficacy of mepolizumab in patients with moderate persistent asthma. Am J Respir Crit Care Med 2007;176(11):1062-71
   PubMed Web of Science ®Google Scholar
• Rothenberg ME, Klion AD, Roufosse FE, et al. Treatment of patients with the hypereosinophilic syndrome with mepolizumab. N Engl J Med 2008;358(12):1215-28
   PubMed Web of Science ®Google Scholar
• Flood-Page PT, Menzies-Gow AN, Kay AB, Robinson DS. Eosinophil’s role remains uncertain as anti-interleukin-5 only partially depletes numbers in asthmatic airway. Am J Respir Crit Care Med 2003;167(2):199-204
   PubMed Web of Science ®Google Scholar
• Bel EH, Wenzel SE, Thompson PJ, et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 2014;371(13):1189-97
   PubMed Web of Science ®Google Scholar
• Haldar P, Brightling CE, Hargadon B, et al. Mepolizumab and exacerbations of refractory eosinophilic asthma. N Engl J Med 2009;360(10):973-84
   PubMed Web of Science ®Google Scholar
• Liu Y, Zhang S, Li DW, Jiang SJ. Efficacy of anti-interleukin-5 therapy with mepolizumab in patients with asthma: a meta-analysis of randomized placebo-controlled trials. PLoS One 2013;8(3):e59872
   PubMed Web of Science ®Google Scholar
• Nair P, Pizzichini MM, Kjarsgaard M, et al. Mepolizumab for prednisone-dependent asthma with sputum eosinophilia. N Engl J Med 2009;360(10):985-93
   PubMed Web of Science ®Google Scholar
• Ortega HG, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014;371(13):1198-207
   PubMed Web of Science ®Google Scholar
• Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet 2012;380(9842):651-9
   PubMed Web of Science ®Google Scholar
• Roufosse FE, Kahn JE, Gleich GJ, et al. Long-term safety of mepolizumab for the treatment of hypereosinophilic syndromes. J Allergy Clin Immunol 2013;131(2):461-7; e1-5
   PubMed Web of Science ®Google Scholar
• Gevaert P, Van Bruaene N, Cattaert T, et al. Mepolizumab, a humanized anti-IL-5 mAb, as a treatment option for severe nasal polyposis. J Allergy Clin Immunol 2011;128(5):989-95; e1-8
   PubMed Web of Science ®Google Scholar
• Mepolizumab in nasal polyposis. Available from: https://clinicaltrials.gov/ct2/show/NCT01362244
   Google Scholar
• Castro M, Mathur S, Hargreave F, et al. Reslizumab for poorly controlled, eosinophilic asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med 2011;184(10):1125-32
   PubMed Web of Science ®Google Scholar
• Kolbeck R, Kozhich A, Koike M, et al. MEDI-563, a humanized anti-IL-5 receptor alpha mAb with enhanced antibody-dependent cell-mediated cytotoxicity function. J Allergy Clin Immunol 2010;125(6):1344-53; e2
   PubMed Web of Science ®Google Scholar
• Laviolette M, Gossage DL, Gauvreau G, et al. Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia. J Allergy Clin Immunol 2013;132(5):1086-96; e5
   PubMed Web of Science ®Google Scholar
• Amini-Vaughan ZJ, Martinez-Moczygemba M, Huston DP. Therapeutic strategies for harnessing human eosinophils in allergic inflammation, hypereosinophilic disorders, and cancer. Curr Allergy Asthma Rep 2012;12(5):402-12
   Google Scholar
• Berair R, Pavord ID. Rationale and clinical results of inhibiting interleukin-5 for the treatment of severe asthma. Curr Allergy Asthma Rep 2013;13(5):469-76
   Google Scholar
• Mahdavinia M, Carter RG, Ocampo CJ, et al. Basophils are elevated in nasal polyps of patients with chronic rhinosinusitis without aspirin sensitivity. J Allergy Clin Immunol 2014;133(6):1759-63
   PubMed Web of Science ®Google Scholar
• Molfino NA, Gossage D, Kolbeck R, et al. Molecular and clinical rationale for therapeutic targeting of interleukin-5 and its receptor. Clin Exp Allergy 2012;42(5):712-37
   PubMed Web of Science ®Google Scholar
• Oh CK, Geba GP, Molfino N. Investigational therapeutics targeting the IL-4/IL-13/STAT-6 pathway for the treatment of asthma. Eur Respir Rev 2010;19(115):46-54
   PubMedGoogle Scholar
• Corren J, Lemanske RF, Hanania NA, et al. Lebrikizumab treatment in adults with asthma. N Engl J Med 2011;365(12):1088-98
   PubMed Web of Science ®Google Scholar
• Noonan M, Korenblat P, Mosesova S, et al. Dose-ranging study of lebrikizumab in asthmatic patients not receiving inhaled steroids. J Allergy Clin Immunol 2013;132(3):567-74; e12
   PubMed Web of Science ®Google Scholar
• Scheerens H, Arron JR, Zheng Y, et al. The effects of lebrikizumab in patients with mild asthma following whole lung allergen challenge. Clin Exp Allergy 2014;44(1):38-46
   PubMed Web of Science ®Google Scholar
• De Boever EH, Ashman C, Cahn AP, et al. Efficacy and safety of an anti-IL-13 mAb in patients with severe asthma: a randomized trial. J Allergy Clin Immunol 2014;133(4):989-96
   PubMed Web of Science ®Google Scholar
• A Phase 3 study to evaluate the efficacy and safety of tralokinumab in adults and adolescents with uncontrolled asthma (STRATOS 1) (STRATOS1). Available from: www.clinicaltrials.gov/ct2/show/NCT02161757
   Google Scholar
• Corren J, Busse W, Meltzer EO, et al. A randomized, controlled, phase 2 study of AMG 317, an IL-4Ralpha antagonist, in patients with asthma. Am J Respir Crit Care Med 2010;181(8):788-96
   PubMed Web of Science ®Google Scholar
• Morjaria JB, Proiti M, Polosa R. Stratified medicine in selecting biologics for the treatment of severe asthma. Curr Opin Allergy Clin Immunol 2011;11(1):58-63
   Google Scholar
• Wenzel S, Wilbraham D, Fuller R, et al. Effect of an interleukin-4 variant on late phase asthmatic response to allergen challenge in asthmatic patients: results of two phase 2a studies. Lancet 2007;370(9596):1422-31
   PubMed Web of Science ®Google Scholar
• Wenzel S, Ford L, Pearlman D, et al. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med 2013;368(26):2455-66
   PubMed Web of Science ®Google Scholar
• Wechsler ME. Inhibiting interleukin-4 and interleukin-13 in difficult-to-control asthma. N Engl J Med 2013;368(26):2511-13
   PubMed Web of Science ®Google Scholar
• An Evaluation of dupilumab in patients with nasal polyposis and chronic symptoms of sinusitis. Available from: https://clinicaltrials.gov/ct2/show/NCT01920893
   Google Scholar
• Study to evaluate the efficacy and safety of medi9929 (amg 157) in adult subjects with inadequately controlled, severe asthma. Available from: www.clinicaltrials.gov/ct2/show/NCT02054130
   Google Scholar
• Busse WW, Israel E, Nelson HS, et al. Daclizumab improves asthma control in patients with moderate to severe persistent asthma: a randomized, controlled trial. Am J Respir Crit Care Med 2008;178(10):1002-8
   PubMed Web of Science ®Google Scholar
• Cavallari FE, Valera FC, Gallego AJ, et al. Expression of RANTES, eotaxin-2, ICAM-1, LFA-1 and CCR-3 in chronic rhinosinusitis patients with nasal polyposis. Acta Cir Bras 2012;27(9):645-9
   Google Scholar