Exploring the effects of omalizumab in allergic asthma: An analysis of biomarkers in the EXTRA study

American Journal of Respiratory and Critical Care Medicine

Volumn 187, Issue 8, 2013, Pages 804-811

  Hanania, Nicola A ^a   Wenzel, Sally ^b   Roseń, Karin ^c   Hsieh, Hsin Ju ^c   Mosesova, Sofia ^c   Choy, David F ^c   Lal, Preeti ^c   Arron, Joseph R ^c   Harris, Jeffrey M ^c   Busse, William ^d  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

^b UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

^c GENENTECH INC   (United States)

^d UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

Author keywords

Eosinophil; Fractional exhaled nitric oxide; Immunoglobulin E; Periostin; Severe asthma

Indexed keywords

BIOLOGICAL MARKER; NITRIC OXIDE; OMALIZUMAB; PLACEBO; TRANSCRIPTION FACTOR RUNX2;

ADOLESCENT; ADULT; AGED; ALLERGIC ASTHMA; ARTICLE; CHILD; CLINICAL ASSESSMENT; CLINICAL PRACTICE; CONTROLLED STUDY; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; EOSINOPHIL COUNT; FEMALE; HUMAN; LONGITUDINAL STUDY; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PARALLEL DESIGN; POST HOC ANALYSIS; PREDICTOR VARIABLE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; TH2 CELL; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION;

ADOLESCENT; ADULT; AGED; ANTI-ASTHMATIC AGENTS; ANTIBODIES, ANTI-IDIOTYPIC; ANTIBODIES, MONOCLONAL, HUMANIZED; ASTHMA; BIOLOGICAL MARKERS; BREATH TESTS; CELL ADHESION MOLECULES; CHILD; DISEASE PROGRESSION; EOSINOPHILS; FEMALE; HUMANS; MALE; MIDDLE AGED; NITRIC OXIDE; YOUNG ADULT;

EID: 84876883293     PISSN: 1073449X     EISSN: 15354970     Source Type: Journal    
DOI: 10.1164/rccm.201208-1414OC     Document Type: Article

References (37)

1. Bousquet J, Jeffery PK, Busse WW, Johnson M, Vignola AM. Asthma. From bronchoconstriction to airways inflammation and remodeling. Am J Respir Crit Care Med 2000;161:1720-1745. (Pubitemid 30329053)
2. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. 2012. Available from: http://www.ginasthma.org.
3. Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJ, Pauwels RA, Pedersen SE. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma Control study. Am J Respir Crit Care Med 2004;170:836-844. (Pubitemid 39346477)
4. Humbert M, Beasley R, Ayres J, Slavin R, Hebert J, Bousquet J, Beeh KM, Ramos S, Canonica GW, Hedgecock S, 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. (Pubitemid 40293346)
5. Szefler SJ, Martin RJ, King TS, Boushey HA, Cherniack RM, Chinchilli VM, Craig TJ, Dolovich M, Drazen JM, Fagan JK, et al. Significant variability in response to inhaled corticosteroids for persistent asthma. J Allergy Clin Immunol 2002;109:410-418. (Pubitemid 34234189)
6. Szefler SJ, Martin RJ. Lessons learned from variation in response to therapy in clinical trials. J Allergy Clin Immunol 2010;125:285-292.
7. Chung KF. Anti-IgE monoclonal antibody, omalizumab: a new treatment for allergic asthma. Expert Opin Pharmacother 2004;5:439-446. (Pubitemid 38219869)
8. Shields RL, Whether WR, Zioncheck K, O'Connell L, Fendly B, Presta LG, Thomas D, Saban R, Jardieu P. Inhibition of allergic reactions with antibodies to IgE. Int Arch Allergy Immunol 1995;107:308-312.
9. Levine SJ, Wenzel SE. Narrative review: the role of Th2 immune pathway modulation in the treatment of severe asthma and its phenotypes. Ann Intern Med 2010;152:232-237.
10. Woodruff PG, Modrek B, Choy DF, Jia G, Abbas AR, Ellwanger A, Koth LL, Arron JR, Fahy JV. T-helper type 2-driven inflammation defines major subphenotypes of asthma. Am J Respir Crit Care Med 2009;180:388-395.
11. Barnes PJ. The cytokine network in asthma and chronic obstructive pulmonary disease. J Clin Invest 2008;118:3546-3556.
12. Cameron L, Hamid Q, Wright E, Nakamura Y, Christodoulopoulos P, Muro S, Frenkiel S, Lavigne F, Durham S, Gould H. Local synthesis of epsilon germline gene transcripts, IL-4, and IL-13 in allergic nasal mucosa after ex vivo allergen exposure. J Allergy Clin Immunol 2000;106:46-52. (Pubitemid 30482851)
13. Bousquet J, Wenzel S, Holgate S, Lumry W, Freeman P, Fox H. Predicting response to omalizumab, an anti-IgE antibody, in patients with allergic asthma. Chest 2004;125:1378-1386. (Pubitemid 38501353)
14. Bousquet J, Rabe K, Humbert M, Chung KF, Berger W, Fox H, Ayre G, Chen H, Thomas K, Blogg M, et al. Predicting and evaluating response to omalizumab in patients with severe allergic asthma. Respir Med 2007; 101:1483-1492. (Pubitemid 46850589)
15. Wahn U, Martin C, Freeman P, Blogg M, Jimenez P. Relationship between pretreatment specific IgE and the response to omalizumab therapy. Allergy 2009;64:1780-1787.
16. Chibana K, Trudeau JB, Mustovich AT, Hu H, Zhao J, Balzar S, Chu HW, Wenzel SE. IL-13 induced increases in nitrite levels are primarily driven by increases in inducible nitric oxide synthase as compared with effects on arginases in human primary bronchial epithelial cells. Clin Exp Allergy 2008;38:936-946. (Pubitemid 351725847)
17. Dweik RA, Boggs PB, Erzurum SC, Irvin CG, Leigh MW, Lundberg JO, Olin AC, Plummer AL, Taylor DR. 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.
18. Massanari M, Holgate ST, Busse WW, Jimenez P, Kianifard F, Zeldin R. Effect of omalizumab on peripheral blood eosinophilia in allergic asthma. Respir Med 2010;104:188-196.
19. Jia GA, Erickson RW, Choy DF, Mosesova S, Wu LC, Solberg OD, Shikotra A, Carter R, Audusseau S, Hamid Q, et al. Periostin is a systemic biomarker of eosinophilic airway inflammation in asthma. J Allergy Clin Immunol 2012;130:647-654.
20. Corren J, Lemanske RF, Hanania NA, Korenblat PE, Parsey MV, Arron JR, Harris JM, Scheerens H, Wu LC, Su Z, et al. Lebrikizumab treatment in adults with asthma. N Engl J Med 2011;365:1088-1098.
21. Novartis US and Genentech. Omalizumab (Xolair) label [updated 2010 Jul; accessed 2013 Apr 3]. Available from: www.gene.com
22. Bousquet J, Cabrera P, Berkman N, Buhl R, Holgate S, Wenzel S, Fox H, Hedgecock S, Blogg M, Cioppa GD. The effect of treatment with omalizumab, an anti-IgE antibody, on asthma exacerbations and emergency medical visits in patients with severe persistent asthma. Allergy 2005;60:302-308. (Pubitemid 40293345)
23. Bousquet J, Siergiejko Z, Swiebocka E, Humbert M, Rabe KF, Smith N, Leo J, Peckitt C, Maykut R, Peachey G. Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. Allergy 2011;66:671-678.
24. Busse W, Corren J, Lanier BQ, McAlary M, Fowler-Taylor A, Cioppa GD, van AA, Gupta N. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol 2001;108:184-190. (Pubitemid 32735398)
25. Busse WW, Morgan WJ, Gergen PJ, Mitchell HE, Gern JE, Liu AH, Gruchalla RS, Kattan M, Teach SJ, Pongracic JA, et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. N Engl J Med 2011;364:1005-1015.
26. Hanania NA, Alpan O, Hamilos DL, Condemi JJ, Reyes-Rivera I, Zhu J, Rosen KE, Eisner MD, Wong DA, Busse W. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med 2011;154:573-582.
27. Holgate ST, Chuchalin AG, Hebert J, Lotvall J, Persson GB, Chung KF, Bousquet J, Kerstjens HA, Fox H, Thirlwell J, et al . Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy 2004;34: 632-638. (Pubitemid 38534897)
28. Kulus M, Hebert J, Garcia E, Fowler TA, Fernandez VC, Blogg M. Omalizumab in children with inadequately controlled severe allergic (IgE-mediated) asthma. Curr Med Res Opin 2010;26:1285- 1293.
29. Lanier B, Bridges T, Kulus M, Taylor AF, Berhane I, Vidaurre CF. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol 2009;124:1210-1216.
30. Soler M, Matz J, Townley R, Buhl R, O'Brien J, Fox H, Thirlwell J, Gupta N, Della CG. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J 2001;18: 254-261. (Pubitemid 32776398)
31. American Thoracic Society. Standardization of spirometry, 1994 update. Am J Respir Crit Care Med 1995;152:1107-1136.
32. Lazar AA, Cole BF, Bonetti M, Gelber RD. Evaluation of treatmenteffect heterogeneity using biomarkers measured on a continuous scale: subpopulation treatment effect pattern plot. J Clin Oncol 2010; 28:4539-4544.
33. Juniper EF, Guyatt GH, Willan A, Griffith LE. Determining a minimal important change in a disease-specific quality of life questionnaire. J Clin Epidemiol 1994;47:81-87. (Pubitemid 24034293)
34. Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, Casale TB, Chanez P, Enright PL, Gibson PG, 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.
35. Harris JM, Wong DA, Kapp AV. Development of the Asthma Control Composite outcome measure to predict omalizumab response. Ann Allergy Asthma Immunol 2011;107:273-280.
36. Szefler SJ, Wenzel S, Brown R, Erzurum SC, Fahy JV, Hamilton RG, Hunt JF, Kita H, Liu AH, Panettieri RA Jr, et al. Asthma outcomes: biomarkers. J Allergy Clin Immunol 2012;129:S9-S23.
37. Corren J, Casale TB, Lanier B, Buhl R, Holgate S, Jimenez P. Safety and tolerability of omalizumab. Clin Exp Allergy 2009;39:788-797.