Phase 2a, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of a H4R-antagonist (JNJ-39758979) in Japanese adults with moderate atopic dermatitis

Journal of Dermatology

Volumn 42, Issue 2, 2015, Pages 129-139

  Murata, Yoko ^a   Song, Michael ^b   Kikuchi, Hisayuki ^a   Hisamichi, Katsuya ^a   Xu, Xie L ^b   Greenspan, Andrew ^c   Kato, Mai ^a   Chiou, Chiun Fang ^c   Kato, Takeshi ^a   Guzzo, Cynthia ^c   Thurmond, Robin L ^b   Ohtsuki, Mamitaro ^d   Furue, Masutaka ^e  

^a Janssen Pharmaceutical KK   (Japan)

^b JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^c JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^d JICHI MEDICAL UNIVERSITY   (Japan)

^e KYUSHU UNIVERSITY   (Japan)

Author keywords

atopic dermatitis; H4 receptor; itch; Japan

Indexed keywords

CEFEPIME; JNJ 39758979; PLACEBO; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; SEROTONIN 4 ANTAGONIST; UNCLASSIFIED DRUG; 4-(3-AMINOPYRROLIDIN-1-YL)-6-ISOPROPYLPYRIMIDIN-2-YLAMINE; G PROTEIN COUPLED RECEPTOR; HISTAMINE AGONIST; HISTAMINE RECEPTOR; HRH4 PROTEIN, HUMAN; PYRIMIDINE DERIVATIVE; PYRROLIDINE DERIVATIVE;

ABDOMINAL DISCOMFORT; ABNORMAL LABORATORY RESULT; ADULT; AGED; AGRANULOCYTOSIS; ARTICLE; ASTHMA; ATOPIC DERMATITIS; CHILL; CONTROLLED STUDY; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEBRILE NEUTROPENIA; FEMALE; FEVER; GINGIVITIS; HUMAN; JAPANESE (PEOPLE); MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RHINOPHARYNGITIS; SCORING SYSTEM; ANTAGONISTS AND INHIBITORS; CHEMICALLY INDUCED; CLINICAL TRIAL; DERMATITIS, ATOPIC; EARLY TERMINATION OF CLINICAL TRIAL; JAPAN; SEVERITY OF ILLNESS INDEX; YOUNG ADULT;

ADULT; DERMATITIS, ATOPIC; DOUBLE-BLIND METHOD; EARLY TERMINATION OF CLINICAL TRIALS; FEMALE; HISTAMINE AGONISTS; HUMANS; JAPAN; MALE; NEUTROPENIA; PRURITUS; PYRIMIDINES; PYRROLIDINES; RECEPTORS, G-PROTEIN-COUPLED; RECEPTORS, HISTAMINE; SEVERITY OF ILLNESS INDEX; YOUNG ADULT;

EID: 84922696048     PISSN: 03852407     EISSN: 13468138     Source Type: Journal    
DOI: 10.1111/1346-8138.12726     Document Type: Article

References (44)

1. Akdis CA, Akdis M, Bieber T, et al,. Diagnosis and treatment of atopic dermatitis in children and adults: European Academy of Allergology and Clinical Immunology/American Academy of Allergy, Asthma and Immunology/PRACTALL Consensus Report. European Academy of Allergology; Clinical Immunology/American Academy of Allergy, Asthma and Immunology/PRACTALL Consensus Group. Allergy 2006; 61: 969-987.
2. Homey B, Steinhoff M, Ruzicka T, Leung DY,. Cytokines and chemokines orchestrate atopic skin inflammation. J Allergy Clin Immunol 2006; 118: 178-189.
3. Bieber T,. Atopic dermatitis. N Engl J Med 2008; 358: 1483-1494.
4. Leung DY, Bieber T,. Atopic dermatitis. Lancet 2003; 361: 151-160.
5. Muto T, Hsieh SD, Sakurai Y, et al,. Prevalence of atopic dermatitis in Japanese adults. Br J Dermatol 2003; 148: 117-121.
6. Furue M, Chiba T, Takeuchi S,. Current status of atopic dermatitis in Japan. Asia Pac Allergy 2011; 1: 64-72.
7. Johnson HH Jr, DeOreo GA, Lascheid WP, Mitchell F,. Skin histamine levels in chronic atopic dermatitis. J Invest Dermatol 1960; 34: 237-238.
8. Juhlin L,. Localization and content of histamine in normal and diseased skin. Acta Derm Venereol 1967; 47: 383-391.
9. Horsmanheimo L, Harvima IT, Jarvikallio A, Harvima RJ, Naukkarinen A, Horsmanheimo M,. Mast cells are one major source of interleukin-4 in atopic dermatitis. Br J Dermatol 1994; 131: 348-353.
10. Järvikallio A, Naukkarinen A, Harvima IT, Aalto ML, Horsmanheimo M,. Quantitative analysis of tryptase- and chymase-containing mast cells in atopic dermatitis and nummular eczema. Br J Dermatol 1997; 136: 871-877.
11. 4 receptor: targeting inflammatory disorders. Eur J Pharmacol 2011; 668: 1-5.
12. Gutzmer R, Mommert S, Gschwandtner M, Zwingmann K, Stark H, Werfel T,. The histamine H4 receptor is functionally expressed on TH2 cells. J Allergy Clin Immunol 2009; 123: 619-625.
13. Raap U, Wichmann K, Bruder M, et al,. Correlation of IL-31 serum levels with severity of atopic dermatitis. J Allergy Clin Immunol 2008; 122: 421-423.
14. Glatzer F, Gschwandtner M, Ehling S, et al,. Histamine induces proliferation in keratinocytes from patients with atopic dermatitis through the histamine 4 receptor. J Allergy Clin Immunol 2013; 132: 1358-1367.
15. Cowden JM, Zhang M, Dunford PJ, Thurmond RL,. The histamine H4 receptor mediates inflammation and pruritus in Th2-dependent dermal inflammation. J Invest Dermatol 2010; 130: 1023-1033.
16. Seike M, Furuya K, Omura M, Hamada-Watanabe K, Matsushita A, Ohtsu H,. Histamine H4 receptor antagonist ameliorates chronic allergic contact dermatitis induced by repeated challenge. Allergy 2010; 65: 319-326.
17. Suwa E, Yamaura K, Oda M, Namiki T, Ueno K,. Histamine H4 receptor antagonist reduces dermal inflammation and pruritus in a hapten-induced experimental model. Eur J Pharmacol 2011; 667: 383-388.
18. Matsushita A, Seike M, Okawa H, Kadawaki Y, Ohtsu H,. Advantages of histamine H4 receptor antagonist usage with H1 receptor antagonist for the treatment of murine allergic contact dermatitis. Exp Dermatol 2012; 21: 714-715.
19. Ohsawa Y, Hirasawa N,. The antagonism of histamine H1 and H4 receptors ameliorates chronic allergic dermatitis via anti-pruritic and anti-inflammatory effects in NC/Nga mice. Allergy 2012; 67: 1014-1022.
20. Thurmond RL, Chen B, Dunford PJ, et al,. Clinical and preclinical characterization of the histamine H4 receptor antagonist JNJ 39758979. J Pharmacol Exp Ther 2014; 349: 176-184.
21. 4 receptor antagonist, JNJ 39758979, is effective in reducing histamine-induced pruritus in a randomized clinical study in healthy subjects. J Pharmacol Exp Ther 2014; 350: 181-187.
22. Rajka G, Langeland T,. Grading of the severity of atopic dermatitis. Acta Derm Venereol Suppl (Stockh) 1989; 144 (Suppl): 13-14.
23. Eichenfield L, Lucky A, Boguniewicz M, et al,. Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents. J Am Acad Dermatol 2002; 46: 495-504.
24. Saeki H, Furue M, Furukawa F, et al,. Guidelines for management of atopic dermatitis. J Dermatol 2009; 36: 563-577.
25. Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M,. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol 2001; 10: 11-18.
26. Thurmond RL, Kazerouni K, Chaplan SR, Greenspan AJ,. Peripheral neuronal mechanism of itch 1. Histamine and Itch. In:, Carstens EE, Akiyama T, eds. Itch: Mechanisms and Treatment. Boca Raton, FL: CRC Press, 2014; 143-192.
27. Crosby RD, Kolotkin RL, Williams GR,. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol 2003; 56: 395-407.
28. Norman GR, Sridhar FG, Guyatt GH, Walter SD,. Relation of distribution- and anchor-based approaches in interpretation of changes in health-related quality of life. Med Care 2001; 39: 1039-1047.
29. Schram ME, Spuls PI, Leeflang MM, Lindeboom R, Bos JD, Schmitt J,. EASI, (objective) SCORAD and POEM for atopic eczema: responsiveness and minimal clinically important difference. Allergy 2012; 67: 99-106.
30. Sher LG, Chang J, Patel IB, Balkrishnan R, Fleischer AB Jr,. Relieving the pruritus of atopic dermatitis: a meta-analysis. Acta Derm Venereol 2012; 92: 455-461.
31. Lundberg K, Broos S, Greiff L, Borrebaeck CAK, Lindstedt M,. Histamine H4 receptor antagonism inhibits allergen-specific T-cell responses mediated by human dendritic cells. Eur J Pharmacol 2011; 651: 197-204.
32. Cowden JM, Yu F, Banie H, et al,. The histamine H4 receptor mediates inflammation and Th17 responses in preclinical models of arthritis. Ann Rheum Dis 2014; 73: 600-608.
33. Dunford PJ, O'Donnell N, Riley JP, Williams KN, Karlsson L, Thurmond RL,. The histamine H4 receptor mediates allergic airway inflammation by regulating the activation of CD4 + T cells. J Immunol 2006; 176: 7062-7070.
34. Rossbach K, Wendorff S, Sander K, et al,. Histamine H4 receptor antagonism reduces hapten-induced scratching behaviour but not inflammation. Exp Dermatol 2009; 18: 57-63.
35. Dunford PJ, Williams KN, Desai PJ, Karlsson L, McQueen D, Thurmond RL,. Histamine H4 receptor antagonists are superior to traditional antihistamines in the attenuation of experimental pruritus. J Allergy Clin Immunol 2007; 119: 176-183.
36. Yamaura K, Oda M, Suwa E, Suzuki M, Sato H, Ueno K,. Expression of histamine H4 receptor in human epidermal tissues and attenuation of experimental pruritus using H4 receptor antagonist. J Toxicol Sci 2009; 34: 427-431.
37. Shin N, Covington M, Bian D, et al,. INCB38579, a novel and potent histamine H4 receptor small molecule antagonist with anti-inflammatory pain and anti-pruritic functions. Eur J Pharmacol 2012; 675: 47-56.
38. Sonkoly E, Muller A, Lauerma AI, et al,. IL-31: a new link between T cells and pruritus in atopic skin inflammation. J Allergy Clin Immunol 2006; 117: 411-417.
39. Andersohn F, Konzen C, Garbe E,. Systemic review: agranulocytosis induced by nonchemotherapy drugs. Ann Intern Med 2007; 146: 657-665.
40. Liu ZC, Uetrecht JP,. Clozapine is oxidized by activated human neutrophils to a reactive nitrenium ion that irreversibly binds to the cells. J Pharmacol Exp Ther 1995; 275: 1476-1483.
41. Corzo D, Yunis JJ, Salazar M, et al,. The major histocompatibility complex region marked by HSP70-1 andHSP70-2 variants is associated with clozapine-induced agranulocytosis in two different ethnic groups. Blood 1995; 86: 3835.
42. Tamai H, Sudo T, Kimura A, et al,. Association between the DRB1∗08302 histocompatibility antigen and methimazole-induced agranulocytosis in Japanese patients with Graves disease. Ann Intern Med 1996; 124: 490-494.
43. Yunis JJ, Lieberman J, Yunis EJ,. Major histocompatibility complex associations with clozapine-induced agranulocytosis. The USA experience. Drug Saf 1992; 7 (Suppl 1): 7.
44. Massari NA, Medina VA, Cricco GP, et al,. Antitumor activity of histamine and clozapine in a mouse experimental model of human melanoma. J Dermatol Sci 2013; 72: 252-262.