Effect of individual allergen sensitization on omalizumab treatment outcomes in patients with severe allergic asthma determined using data from the Czech Anti-IgE Registry

. 2020 ; 16 () : 81. [epub] 20200915

Status PubMed-not-MEDLINE Jazyk angličtina Země Anglie, Velká Británie Médium electronic-ecollection

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/pmid32944035

BACKGROUND: Omalizumab is an efficient drug for patients with uncontrolled severe allergic asthma (SAA). However, little is known about the differences in omalizumab treatment outcomes among patients with different types of atopic sensitization. Here, we assessed the effect of sensitization to individual allergens or their combinations on the outcomes of anti-IgE therapy in patients with SAA. METHODS: We performed a post hoc analysis of data of subgroups of patients enrolled in the Czech Anti-IgE Registry (CAR). The patients were evaluated at baseline and 16 weeks and 12 months after omalizumab treatment initiation. We analyzed the dependence of primary treatment outcomes [global evaluation of treatment effectiveness (GETE) after 16 weeks of treatment, a reduction in severe exacerbation rate (ER), and an improvement in the asthma control test (ACT) result during 12 months of treatment] and secondary outcomes [a reduction in systemic corticosteroid (SCS) use, an improvement in lung functions, and a fraction of exhaled nitric oxide] of patients with SAA treated with omalizumab for 12 months on sensitization to different perennial aeroallergens. We assessed sensitization to house dust mites, molds, and pets at baseline using skin prick tests and/or specific IgE measurement (semiquantitative evaluation). We compared polysensitized patients (sensitized to all tested allergens) with monosensitized (single positivity) or partially polysensitized patients (combined positivity but not to all allergens). RESULTS: We enrolled 279 patients (58.3% women, mean age 52.9 years). Omalizumab treatment presented an 82.8% response rate (according to GETE). It significantly reduced severe asthma exacerbations and SCS use, and improved the ACT result in 161 responders. We identified a subgroup of responders with distinct sensitization patterns (polysensitization to all tested perennial allergens) with higher odds of being responders (OR = 2.217, p = 0.02) and lower tendency to improve ACT result (OR 0.398, p = 0.023) and reduce ER (OR 0.431, p = 0.034) than non-polysensitized patients. CONCLUSIONS: The clinical benefit of sensitization for patients with SAA receiving omalizumab may be particularly dependent on sensitization pattern. Polysensitized patients showed a higher tendency to be responders (GETE), but a lower tendency to improve the ACT result and reduce ER than non-polysensitized patients.

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Fahy JV. Type 2 inflammation in asthma—present in most, absent in many. Nat Rev Immunol. 2015;15:57–65. PubMed PMC

Woodruff PG, Modrek B, Choy DF, Jia G, Abbas AR, Ellwanger A, et al. T-helper type 2-driven inflammation defines major subphenotypes of asthma. Am J Respir Crit Care Med. 2009;180:388–395. PubMed PMC

Terl M, Pohunek P, Kuhn M, Bystron J. Four seasons of Czech asthma study: asthma characteristics and management reality in the Czech Republic. J Asthma. 2019;1–13. PubMed

Robinson D, Humbert M, Buhl R, Cruz AA, Inoue H, Korom S, et al. Revisiting type 2-high and type 2-low airway inflammation in asthma: current knowledge and therapeutic implications. Clin Exp Allergy. 2017;47:161–175. PubMed

Coverstone AM, Seibold MA, Peters MC. Diagnosis and management of T2-high asthma. J Allergy Clin Immunol Pract. 2020;8:442–450. PubMed

Kuruvilla ME, Lee FEH, Lee GB. Understanding asthma phenotypes, endotypes, and mechanisms of disease. Clin Rev Allergy Immunol. 2019;56:219–233. PubMed PMC

Terl M, Sedlák V, Cap P, Dvořáková R, Kašák V, Kočí T, et al. Asthma management: a new phenotype-based approach using presence of eosinophilia and allergy. Allergy Eur J Allergy Clin Immunol. 2017;72:1279–1287. PubMed

Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma task force report ERS/ATS guidelines on severe asthma executive summary. Eur Respir J. 2014;43:343–373. PubMed

Bousquet J, Siergiejko Z, Świebocka E, Humbert M, Rabe KF, Smith N, et al. Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. Allergy. 2011;66:671–678. PubMed

Humbert M, Beasley R, Ayres J, Slavin R, Hébert J, Bousquet J, et al. Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): iNNOVATE. Allergy. 2005;60:309–316. PubMed

Deschildre A, Marguet C, Salleron J, Pin I, Rittié JL, Derelle J, et al. Add-on omalizumab in children with severe allergic asthma: a 1-year real life survey. Eur Respir J. 2013;42:1224–1233. PubMed

Korn S, Thielen A, Seyfried S, Taube C, Kornmann O, Buhl R. Omalizumab in patients with severe persistent allergic asthma in a real-life setting in Germany. Respir Med. 2009;103:1725–1731. PubMed

Barnes N, Menzies-Gow A, Mansur AH, Spencer D, Percival F, Radwan A, et al. Effectiveness of omalizumab in severe allergic asthma: a retrospective UK real-world study. J Asthma. 2013;50:529–536. PubMed PMC

Kuprys-Lipinska I, Majak P, Molinska J. Effectiveness of the Polish program for the treatment of severe allergic asthma with omalizumab: a single-center experience. BMC Pulm Med. 2016;16:1–9. PubMed PMC

Kirchnerová OR, Valena T, Novosad J, Teřl M. Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic. Adv Dermatol Allergol. 2019;36:34–43. PubMed PMC

EMA. Summary of product characteristics—Xolair 2018:1–33.

Domingo C, Pomares X, Navarro A, Rudi N, Sogo A, Dávila I, et al. Omalizumab is equally effective in persistent allergic oral corticosteroid-dependent asthma caused by either seasonal or perennial allergens: a pilot study. Int J Mol Sci. 2017;18:521. PubMed PMC

Pedersen SE, Bateman ED, Boulet L-P, Cruz AA, FitzGerald JM, Inoue H, et al. Global strategy for asthma management and prevention (2018 Update). 2018.

Milan Teřl A, Čáp P, Dvořáková R, Kašák V, Kočí T, Novotná B, et al. Recommended procedure for diagnosis and treatment of asthma bronchiale. 1st ed. Geum. 2015.

Custovic A, Johnston SL, Pavord I, Gaga M, Fabbri L, Bel EH, et al. EAACI position statement on asthma exacerbations and severe asthma. Allergy. 2013;68:1520–1531. PubMed PMC

Bousquet J, Mantzouranis E, Cruz AA, Aït-Khaled N, Baena-Cagnani CE, Bleecker ER, et al. Uniform definition of asthma severity, control, and exacerbations: document presented for the World Health Organization Consultation on Severe Asthma. J Allergy Clin Immunol. 2010;126:926–938. PubMed

Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, et al. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations—standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180:59–99. PubMed

Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, et al. Standardisation of spirometry. Eur Respir J. 2005;26:319–338. PubMed

Measurement O. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005;171:912–930. PubMed

Dweik RA, Boggs PB, Erzurum SC, Irvin CG, Leigh MW, Lundberg JO, et al. An official ATS clinical practice guideline: interpretation of exhaled nitric oxide levels (FENO) for clinical applications. Am J Respir Crit Care Med. 2011;184:602–615. PubMed PMC

Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, et al. Development of the Asthma Control Test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004;113:59–65. PubMed

Schatz M, Sorkness CA, Li JT, Marcus P, Murray JJ, Nathan RA, et al. Asthma control test: reliability, validity, and responsiveness in patients not previously followed by asthma specialists. J Allergy Clin Immunol. 2006;117:549–556. PubMed

Bousquet J, Heinzerling L, Bachert C, Papadopoulos NG, Bousquet PJ, Burney PG, et al. Practical guide to skin prick tests in allergy to aeroallergens. Allergy Eur J Allergy Clin Immunol. 2012;67:18–24. PubMed

Lloyd A, Turk F, Leighton T, Canonica GW. Psychometric evaluation of global evaluation of treatment effectiveness: a tool to assess patients with moderate-to-severe allergic asthma. J Med Econ. 2007;10:285–296.

Chanez P, Contin-Bordes C, Garcia G, Verkindre C, Didier A, De Blay F, et al. Omalizumab-induced decrease of FceRI expression in patients with severe allergic asthma. Respir Med. 2010;104:1608–1617. PubMed

Froidure A, Mouthuy J, Durham SR, Chanez P, Sibille Y, Pilette C. Asthma phenotypes and IgE responses. Eur Respir J. 2016;47:304–319. PubMed

Ballow M, Akdis CA, Casale TB, Wardlaw AJ, Wenzel SE, Ballas Z, et al. Immune response modifiers in the treatment of asthma: a PRACTALL document of the American Academy of Allergy, Asthma & Immunology and the European Academy of Allergy and Clinical Immunology. J Allergy Clin Immunol. 2012;130:311–324. PubMed

Kuhl K, Hanania NA. Targeting IgE in asthma. Curr Opin Pulm Med. 2012;18:1–5. PubMed

Varghese M, Lieberman P. The effects of repeat omalizumab administration on skin test positivity and the assessment of the safety of administration in patients with positive skin tests to mouse antigen. Allergy Asthma Proc. 2007;28:320–323. PubMed

Corren J, Shapiro G, Reimann J, Deniz Y, Wong D, Adelman D, et al. Allergen skin tests and free IgE levels during reduction and cessation of omalizumab therapy. J Allergy Clin Immunol. 2008;121:506–511. PubMed

Ong YE, Menzies-Gow A, Barkans J, Benyahia F, Ou TT, Ying S, et al. Anti-IgE (omalizumab) inhibits late-phase reactions and inflammatory cells after repeat skin allergen challenge. J Allergy Clin Immunol. 2005;116:558–564. PubMed

Yalcin AD. An overview of the effects of anti-IgE therapies. Med Sci Monit. 2014;20:1691–1699. PubMed PMC

Teach SJ, Gill MA, Togias A, Sorkness CA, Arbes SJ, Calatroni A, et al. Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations. J Allergy Clin Immunol. 2015;136:1476–1485. PubMed PMC

Hanania NA, Wenzel S, Roseń K, Hsieh HJ, Mosesova S, Choy DF, et al. Exploring the effects of omalizumab in allergic asthma: an analysis of biomarkers in the EXTRA study. Am J Respir Crit Care Med. 2013;187:804–811. PubMed

Humbert M, Taillé C, Mala L, Le Gros V, Just J, Molimard M, et al. Omalizumab effectiveness in patients with severe allergic asthma according to blood eosinophil count: the STELLAIR study. Eur Respir J. 2018;51:1702523. PubMed PMC

Casale TB, Luskin AT, Busse W, Zeiger RS, Trzaskoma B, Yang M, et al. Omalizumab effectiveness by biomarker status in patients with asthma: evidence from PROSPERO, a prospective real-world study. J Allergy Clin Immunol Pract. 2019;7:156–164. PubMed

Shrestha Palikhe N, Bosonea A-M, Laratta C, et al. Stability of peripheral blood immune markers in patients with asthma. Allergy Asthma Clin Immunol. 2019;15:30. PubMed PMC

Lombardi C, Savi E, Ridolo E, Passalacqua G, Canonica GW. Is allergic sensitization relevant in severe asthma? Which allergens may be culprit? World Allergy Organ J. 2017;10:2. PubMed PMC

Li J, Huang Y, Lin X, Zhao D, Tan G, Wu J, et al. Influence of degree of specific allergic sensitivity on severity of rhinitis and asthma in Chinese allergic patients. Respir Res. 2011;12:95. PubMed PMC

Domínguez-Ortega J, Quirce S, Delgado J, Dávila I, Martí-Guadaño E, Valero A. Diagnostic and therapeutic approaches in respiratory allergy are different depending on the profile of aeroallergen sensitisation. Allergol Immunopathol. 2014;42:11–18. PubMed

Sedlák V, Chlumský J, Teřl M, Novotná B, Král B. Recommended procedure for diagnosis and treatment of difficult to treat asthma. 2016.

Global Initiative for Asthma (GINA). Difficult-to-treat severe asthma in adolescent and adult patients GINA Pocket Guide for Health Professionals Diagnosis and Management. 2019.

Braunstahl GJ, Chen CW, Maykut R, Georgiou P, Peachey G, Bruce J. The eXpeRience registry: the “real-world” effectiveness of omalizumab in allergic asthma. Respir Med. 2013;107:1141–1151. PubMed

Namazy JA, Blais L, Andrews EB, Scheuerle AE, Cabana MD, Thorp JM, et al. Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort. J Allergy Clin Immunol. 2020;145:528–536. PubMed

Namazy J, Cabana MD, Scheuerle AE, Thorp JM, Chen H, Carrigan G, et al. The Xolair Pregnancy Registry (EXPECT): the safety of omalizumab use during pregnancy. J Allergy Clin Immunol. 2015;135:407–412. PubMed

Agarwal R, Nath A, Aggarwal AN, Gupta D, Chakrabarti A. Aspergillus hypersensitivity and allergic bronchopulmonary aspergillosis in patients with acute severe asthma in a respiratory intensive care unit in North India. Mycoses. 2010;53:138–143. PubMed

Virchow JC, Backer V, Kuna P, Prieto L, Nolte H, Villesen HH, et al. Efficacy of a house dust mite sublingual allergen immunotherapy tablet in adults with allergic asthma. JAMA. 2016;315:1715–1725. PubMed

McIvor RA. Emerging therapeutic options for the treatment of patients with symptomatic asthma. Ann Allergy Asthma Immunol. 2015;115(265–271):e5. PubMed

Peters MC, Ringel L, Dyjack N, Herrin R, Woodruff PG, Rios C, et al. A transcriptomic method to determine airway immune dysfunction in T2-high and T2-low asthma. Am J Respir Crit Care Med. 2019;199:465–477. PubMed PMC

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