Effect of an interleukin-4 variant on late phase asthmatic response to allergen challenge in asthmatic patients: results of two phase 2a studies

Lancet

Volumn 370, Issue 9596, 2007, Pages 1422-1431

  Wenzel, Sally ^a   Wilbraham, Darren ^b   Fuller, Rick ^c   Getz, Elise Burmeister ^c   Longphre, Malinda ^c  

^a UNIVERSITY OF PITTSBURGH   (United States)

^b IQVIA   (United States)

^c Aerovance Incorporated   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALLERGEN; BETA ADRENERGIC RECEPTOR STIMULATING AGENT; INTERLEUKIN 13; INTERLEUKIN 4; INTERLEUKIN 4 RECEPTOR ALPHA; PITRAKINRA; PLACEBO; UNCLASSIFIED DRUG;

ABDOMINAL DISCOMFORT; ADULT; ALLERGIC ASTHMA; ALLERGIC REACTION; ARTICLE; BACKACHE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRY SKIN; DYSMENORRHEA; DYSPNEA; FEMALE; FOLLOW UP; FORCED EXPIRATORY VOLUME; HUMAN; INFLAMMATION; INJECTION SITE DISCOMFORT; MALE; MENORRHAGIA; NAUSEA; NOSE CONGESTION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEIN BINDING; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SOMNOLENCE; TH2 CELL; THORAX PAIN; UPPER RESPIRATORY TRACT INFECTION; WHEEZING;

EID: 35348909044     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(07)61600-6     Document Type: Article

References (40)

1. Kay A. The role of T lymphocytes in asthma. Chem Immunol Allergy 91 (2006) 59-75
2. Brown J., Behndig A., Sekerel B., et al. Lower airways inflammation in allergic rhinitics: a comparison with asthmatics and normal controls. Clin Exp Allergy 37 (2007) 688-695
3. Wills-Karp M., Luyimbazi J., Xu X., et al. Interleukin-13: central mediator of allergic asthma. Science 282 (1998) 2258-2261
4. Gavett S., O'Hearn D., Karp C., et al. Interleukin-4 receptor blockade prevents airway responses induced by antigen challenge in mice. Am J Physiol 272 (1997) L253-L261
5. Grunig G., Warnock M., Wakil A., et al. Requirement for IL-13 independently of IL-4 in experimental asthma. Science 282 (1998) 2261-2263
6. Venkayya R., Lam M., Willkom M., Grunig G., Corry D., and Erle D. The Th2 lymphocyte products IL-4 and IL-13 rapidly induce airway hyperresponsiveness through direct effects on resident airway cells. Am J Respir Cell Mol Biol 26 (2002) 202-208
7. Padilla J., Daley E., Chow A., et al. IL-13 regulates the immune response to inhaled antigens. J Immunol 174 (2005) 8097-8105
8. O'Byrne P., Inman M., and Adelroth E. Reassessing the Th2 cytokine basis of asthma. Trends Pharmacol Sci 25 (2004) 244-248
9. Perkins C., Wills-Karp M., and Finkelman F. IL-4 induces IL-13-independent allergic airway inflammation. J Allergy Clin Immunol 118 (2006) 410-419
10. Kelly-Welch A., Hanson E., Boothby M., and Keegan A. Interleukin-4 and interleukin-13 signaling connections maps. Science 300 (2003) 1527-1528
11. Hart P., Bonder C., Balogh J., Dickensheets H., Donnelly R., and Finlay-Jones J. Differential responses of human monocytes and macrophages to IL-4 and IL-13. J Leukoc Biol 66 (1999) 575-578
12. Tomkinson A., Stevens L., Morton M., et al. Therapeutic effects of inhaled AER 001, an IL-4/13 antagonist, on allergen-induced airway hyperresponsiveness (AHR) and airway inflammation. Proc Am Thorac Soc 3 (2006) A521
13. Harris P., Lindell D., Fitch N., and Gundel R. The IL-4 receptor antagonist (BAY-16-9996) reverses airway hyperresponsiveness in a primate model of asthma. Am J Respir Crit Care Med 159 (1999) A230
14. Morton M., Harris P., Xu J., et al. The effects of an IL-4 receptor antagonist (BAY 16-9996) on antigen-induced cutaneous wheal and flare reactions in the primate. Am J Respir Crit Care Med 159 (1999) A660
15. Groves R., Wilbraham D., Fuller R., Burmeister-Getz E., and Longphre M. AERODERM protects against flares in atopic eczema: the results of a phase 2 clinical study. J Invest Dermatol 127 (2007) 320
16. Miller M., Hankinson J., Brusasco V., et al. Standardisation of spirometry. Eur Respir J 26 (2006) 319-338
17. Miller M., Crapo R., Hankinson J., et al. General considerations for lung function testing. Eur Respir J 26 (2006) 154-159
18. Crapo R., Casaburi R., Coates A., et al. Guidelines for methacholine and exercise challenge testing 1999. Am J Respir Crit Care Med 161 (2000) 309-329
19. Joos G., O'Connor B., Anderson S., et al. Indirect airway challenges. Eur Respir J 21 (2003) 1050-1068
20. American Thoracic Society, European Respiratory Society. 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 171 (2005) 912-930
21. Mire-Sluis A., Barrett Y., Devanarayan V., et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods 289 (2004) 1-16
22. Hessel E., Chu M., Lizcano J., et al. Immunostimulatory oligonucleotides block allergic airway inflammation by inhibiting Th2 cell activation and IgE-mediated cytokine induction. J Exp Med 202 (2005) 1563-1573
23. Blease K., Jakubzick C., Westwick J., Lukacs N., Kunkel S., and Hogaboam C. Therapeutic effect of IL-13 immunoneutralization during chronic experimental fungal asthma. J Immunol 166 (2001) 5219-5224
24. Wills-Karp M. Murine models of asthma in understanding immune dysregulation in human asthma. Immunopharmacology 48 (2000) 263-268
25. McKenzie A., and Fallon P. Decoy receptors in the regulation of T helper cell type 2 responses. J Exp Med 197 (2003) 675-679
26. Mueller T., Zhang J., Sebald W., and Duschl A. Structure, binding, and antagonists in the IL-4/IL-13 receptor system. Biochim Biophys Acta 1592 (2002) 237-250
27. Taylor D., Pijnenburg M., Smith A., and De Jongste J. Exhaled nitric oxide measurements: clinical application and interpretation. Thorax 61 (2006) 817-827
28. Suresh V., Mih J., and George S. Measurement of IL-13-induced iNOS-derived gas phase nitric oxide in human bronchial epithelial cells. Am J Respir Cell Mol Biol 37 (2007) 97-104
29. Trudeau J., Chu H., Hu H., Bleecker E., Meyers D., and Wenzel S. Interleukin-13 increases iNOS expression in human air-liquid interface epithelial cells. Proc Am Thoracic Soc 3 (2006) A66
30. Guo F., Comhair S., Zheng S., et al. Molecular mechanisms of increased nitric oxide (NO) in asthma: evidence for transcriptional and post-translational regulation of NO synthesis. J Immunol 164 (2000) 5970-5980
31. Guo F., and Erzurum S. Characterization of inducible nitric oxide synthase expression in human airway epithelium. Environ Health Perspect 106 suppl 5 (1998) 1119-1124
32. Conti C. Nitric oxide as a therapeutic agent. Clin Cardiol 17 (1994) 227-278
33. Cohn L., Homer R., MacLeod H., Mohrs M., Brombacher F., and Bottomly K. Th2-induced airway mucus production is dependent on IL-4Ralpha, but not on eosinophils. J Immunol 162 (1999) 6178-6183
34. Nakajima H., and Takatsu K. Role of cytokines in allergic airway inflammation. Int Arch Allergy Immunol 142 (2007) 265-273
35. Howard T., Koppelman G., Xu J., et al. Gene-gene interaction in asthma: IL4RA and IL13 in a Dutch population with asthma. Am J Hum Genet 70 (2002) 230-236
36. Wenzel S., Balzar S., Ampleford E., et al. IL4R alpha mutations are associated with asthma exacerbations and mast cell/IgE expression. Am J Respir Crit Care Med 175 (2007) 570-576
37. Juniper E., Kline P., Vanzieleghem M., Ramsdale E., O'Byrne P., and Hargreave F. Effect of long-term treatment with an inhaled corticosteroid (budesonide) on airway hyperresponsiveness and clinical asthma in nonsteroid-dependent asthmatics. Am Rev Respir Dis 142 (1990) 832-836
38. Fahy J., Cockcroft D., Boulet L., et al. Effect of aerosolized anti-IgE (E25) on airway responses to inhaled allergen in asthmatic subjects. Am J Respir Crit Care Med 160 (1999) 1023-1027
39. Taylor I., O'Shaughnessy K., Fuller R., and Dollery C. Effect of cysteinyl-leukotriene receptor antagonist ICI 204.219 on allergen-induced bronchoconstriction and airway hyperreactivity in atopic subjects. Lancet 337 (1991) 690-694
40. Gauvreau G., Doctor J., Watson R., Jordana M., and O'Byrne P. Effects of inhaled budesonide on allergen-induced airway responses and airway inflammation. Am J Respir Crit Care Med 154 (1996) 1267-1271