Modeling the effects of Omalizumab over 5 years among patients with moderate-to-severe persistent allergic asthma

Current Medical Research and Opinion

Volumn 26, Issue 12, 2010, Pages 2779-2793

  Grossman, H L ^a   Schlender, Amory ^a   Alperin, Peter ^a   Stanley, Elizabeth L ^b   Zhang, Jie ^b  

^a Archimedes Inc   (United States)

^b NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Anti IgE; Asthma; Computer simulation; Omalizumab

Indexed keywords

BETA ADRENERGIC RECEPTOR STIMULATING AGENT; CORTICOSTEROID; OMALIZUMAB;

ADULT; ALLERGIC ASTHMA; ARTICLE; CLINICAL TRIAL; DISEASE CONTROL; DISEASE SEVERITY; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; PATIENT COMPLIANCE; PRACTICE GUIDELINE; PREDICTION; SIMULATION; SYMPTOM;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTI-ASTHMATIC AGENTS; ANTIBODIES, MONOCLONAL; ASTHMA; CHILD; COMPUTER SIMULATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; HYPERSENSITIVITY; MALE; MIDDLE AGED; MODELS, THEORETICAL; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 78349242069     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2010.526101     Document Type: Article

References (49)

1. Xolair (omalizumab) for Subcutaneous Use, US package insert. South San Francisco, CA: Genentech, Inc, July 2008
2. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Bethesda, MD: U.S. Department of Health and Human Services; National Institutes of Health; National Heart, Lung, and Blood Institute; National Asthma Education and Prevention Program, 2007
3. 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;108:184-90
4. Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics 2001;108:E36
5. Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J 2001;18:254-61
6. Holgate ST, Chuchalin AG, Hebert J, et al. Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy 2004;34:632-8
7. Vignola AM, Humbert M, Bousquet J, et al. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with concomitant allergic asthma and persistent allergic rhinitis: SOLAR. Allergy. 2004;59:709-17
8. Humbert M, Beasley R, Ayres 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;60:309-16
9. Ayres JG, Higgins B, Chilvers ER, et al. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma. Allergy 2004;59:701-8
10. Buhl R, Soler M, Matz J, et al. Omalizumab provides long-term control in patients with moderate-to-severe allergic asthma. Eur Respir J. 2002; 20:73-8
11. Lanier BQ, Corren J, Lumry W, et al. Omalizumab is effective in the long-term control of severe allergic asthma. Ann Allergy Asthma Immunol. 2003;91: 154-9
12. Bousquet J, Cabrera P, Berkman N, et al. 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; 60:302-8
13. Walker S, Monteil M, Phelan K, et al. Anti-IgE for chronic asthma in adults and children. Cochrane Database Syst Rev 2006;(2):CD003559
14. Details about the construction, calibration, and validation of the Archimedes Asthma Model were presented at the International Conference from the American Thoracic Society, New Orleans, LA, May 14-19, 2010.
15. Schlender A, Grossman HL, Alperin P, Sutherland ER. The construction, calibration, and validation of an epidemiological computer model of chronic asthma.
16. Mandelblatt JS, Cronin KA, Bailey S, et al. Effects of mammography screening under different screening schedules: model estimates of potential benefits and harms. Ann Intern Med 2009;151:738-47
17. Zauber AG, Lansdorp-Vogelaar I, Knudsen AB, et al. Evaluating test strategies for colorectal cancer screening: a decision analysis for the U.S. Preventive Services Task Force. Ann Intern Med 2008;149:659-69
18. Dudl RJ, Wang MC, Wong M, et al. Preventing myocardial infarction and stroke with a simplified bundle of cardioprotective medications. Am J Manag Care 2009;15:e88-94
19. Paltiel AD, Fuhlbrigge AL, Kitch BT, et al. Cost-effectiveness of inhaled cor-ticosteroids in adults with mild-to-moderate asthma: results from the asthma policy model. J Allergy Clin Immunol 2001;108:39-46
20. Kahn R, Alperin P, Eddy D, et al. Age at initiation and frequency of screening to detect type 2 diabetes: a cost-effectiveness analysis. Lancet 2010;375: 1365-74
21. Eddy DM, Schlessinger L, Kahn R. Clinical outcomes and cost-effectiveness of strategies for managing people at high risk for diabetes. Ann Intern Med 2005;143:251-64
22. Eddy DM, Pawlson LG, Schaaf D, et al. The potential effects of HEDIS performance measures on the quality of care. Health Aff 2008;27:1429-41
23. Kahn R, Robertson RM, Smith R, et al. The impact of prevention on reducing the burden of cardiovascular disease. Circulation 2008;118:576-85
24. Centers for Disease Control and Prevention (CDC). National Center for Environmental Health (NCEH). National Asthma Survey (NAS), 2003-2004. Available at: http://www.cdc.gov/nchs/slaits/nas.htm [Last accessed 11 December 2009]
25. Centers for Disease Control and Prevention (CDC). National Center for Health Statistics (NCHS). National Hospital Discharge Survey (NHDS), 2004-2006. Available at: http://www.cdc.gov/nchs/nhds.htm [Last accessed 14 December 2009]
26. Tattersfield AE, Postma DS, Barnes PJ, et al. Exacerbations of asthma: a descriptive study of 425 severe exacerbations. Am J Respir Crit Care Med 1999;160:594-9
27. Lange P, Parner J, Vestbo J, et al. A 15-year follow-up study of ventilatory function in adults with asthma. N Engl J Med 1998;339:1194-200
28. Carranza Rosenzweig JR, Edwards L, Lincourt W, et al. The relationship between health-related quality of life, lung function and daily symptoms in patients with persistent asthma. Respir Med 2004;98:1157-65
29. McFadden Jr. ER Acute severe asthma. Am J Respir Crit Care Med 2003; 168:740-59
30. Cerveri I, Locatelli F, Zoia MC, et al. International variations in asthma treatment compliance. Eur Respir J 1999;14:288-294
31. Martin TG, Elenbaas RM, Pingleton SH. Failure of peak expiratory flow rate to predict hospital admission in acute asthma. Ann Emerg Med 1982; 11:466-70
32. Adams NP, Bestall JB, Malouf R, et al. Inhaled beclomethasone versus placebo for chronic asthma. Cochrane Database Syst Rev 2005;(1):CD002738
33. Ni Chroinin M, Greenstone IR, Danish A, et al. Long-acting beta2-agonists versus placebo in addition to inhaled corticosteroids in children and adults with chronic asthma. Cochrane Database Syst Rev 2005;(4): CD005535
34. Rowe BH, Spooner CH, Ducharme FM, et al. Corticosteroids for preventing relapse following acute exacerbations of asthma. Cochrane Database Syst Rev 2007;(3):CD000195
35. Powell H, Gibson PG. High dose versus low dose inhaled corticosteroid as initial starting dose for asthma in adults and children. Cochrane Database Syst Rev 2004;(2):CD004109
36. Haselkorn T, Borish L, Miller DP, et al. High prevalence of skin test positivity in severe or difficult-to-treat asthma. J Asthma 2006;43:745-52
37. Hawkins G, McMahon AD, Twaddle S, et al. Stepping down inhaled cortico-steroids in asthma: randomised controlled trial. BMJ 2003;326:1115
38. Bousquet J, Wenzel S, Holgate S, et al. Predicting response to omalizumab, an anti-IgE antibody, in patients with allergic asthma. Chest 2004;125:1378-86
39. Bousquet J, Rabe K, Humbert M, et al. Predicting and evaluating response to omalizumab in patients with severe allergic asthma. Respir Med 2007; 10:1483-92
40. Ayre G, Fox H, Chen H, et al. Evaluating response to omalizumab (anti-IgE) in clinical practice. Poster presented at the European Respiratory Society Meeting, 17-21 September 2005, Copenhagen
41. Bousquet J, Cabrera P, Berkman N, et al. 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; 60:302-8
42. Rao CR. The theory of least squares when the parameters are stochastic and its application to the analysis of growth curves. Biometrika 1965;52: 447-58
43. Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics 1982;38:963-74
44. Bevington P, Robinson D. Data Reduction and Error Analysis for the Physical Sciences. New York: McGraw Hill, 2002
45. Dahl R. Systemic side effects of inhaled corticosteroids in patients with asthma. Respir Med 2006;100:1307-17
46. Lipworth BJ. Systemic adverse effects of inhaled corticosteroid therapy: a systematic review and meta-analysis. Arch Intern Med 1999;159:941-55
47. Walsh LJ, Wong CA, Oborne J, et al. Adverse effects of oral corticosteroids in relation to dose in patients with lung disease. Thorax 2001;56:279-84
48. Condemi JJ, Hamilos DL, Hanania NA, et al. Efficacy and safety of omalizu-mab in patients with moderate-to-severe persistent asthma poorly controlled on high-dose inhaled corticosteroids and long-acting beta-agonists results of a phase IIIb randomized controlled trial type: late breaker. Am J Respir Crit Care Med 2010;181:A6840
49. Gergen PJ, Arbes Jr SJ, Calatroni A, et al. Total IgE levels and asthma prevalence in the US population: results from the National Health and Nutrition Examination Survey 2005-2006. J Allergy Clin Immunol 2009; 124:447-53