A phase I study evaluating the safety, pharmacokinetics, and clinical response of a human IL-12 p40 antibody in subjects with plaque psoriasis

Journal of Investigative Dermatology

Volumn 123, Issue 6, 2004, Pages 1037-1044

  Kauffman, Catharine L ^a   Aria, Nancy ^a   Toichi, Eiko ^b   McCormick, Thomas S ^b   Cooper, Kevin D ^b   Gottlieb, Alice B ^c   Everitt, Daniel E ^d   Frederick, Bart ^d   Zhu, Yaowei ^d   Graham, Martin A ^d   Pendley, Charles E ^d   Mascelli, Mary Ann ^d  

^a GEORGETOWN UNIVERSITY   (United States)

^b CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

^d CENTOCOR INC   (United States)

Author keywords

Anti IL 12p40; Interleukin 12; Interleukin 23; PASI; Psoriasis

Indexed keywords

ANTIPSORIASIS AGENT; INTERLEUKIN 12 ANTIBODY; PROTEIN ANTIBODY; PROTEIN P40 ANTIBODY; UNCLASSIFIED DRUG;

ADULT; ARTICLE; BACKACHE; BODY SURFACE; CLINICAL ARTICLE; CLINICAL TRIAL; COMMON COLD; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DELAYED HYPERSENSITIVITY; DISEASE EXACERBATION; DISEASE SEVERITY; DOSE RESPONSE; DRUG HALF LIFE; DRUG SAFETY; FEMALE; FOLLOW UP; HEADACHE; HUMAN; IMMEDIATE TYPE HYPERSENSITIVITY; LYMPHOCYTOPENIA; MALE; OPEN STUDY; PAIN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PSORIASIS VULGARIS; SIDE EFFECT; TREATMENT OUTCOME;

EID: 9744265704     PISSN: 0022202X     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.0022-202X.2004.23448.x     Document Type: Article

References (24)

1. Abbas AK, Lichtman AH, Pober JS: Cellular and Molecular Immunology, 4th ed. Philadelphia: WB Saunders Company, 2000
2. Barker JN, Karabin GD, Stoof TJ, Sarma VJ, Dixit VM, Nickiloff BJ: Detection of interferon-gamma mRNA in psoriatic epidermis by polymerase chain reaction. J Dermatol Sci 2:106-111, 1991
3. Boyman O, Hefti HP, Conrad C, et al: Spontaneous development of psoriasis in a new animal model shows an essential role for resident T cells and tumor necrosis factor-α. J Exp Med 199:731-736, 2004
4. Brok HP, van Meurs M, Blezer E, et al: Prevention of experimental autoimmune encephalomyeletis in common marmosets using an anti-IL-12p40 monoclonal antibody. J Immunol 169:6554-6563, 2002
5. Chaudhari U, Romano P, Mulcahy LD, Dooley LT, Baker DG, Gottlieb AB: Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: A randomised trial. Lancet 357:1842-1847, 2001
6. Christophers E, Sterry W: Psoriasis. In: Fitzpatrick TB, Eisen AZ, Wolff K, Freedberg IM, Austen KF (eds). Dermatology in General Medicine. New York, NY: McGraw-Hill, 1993; p 489-514
7. Cua DJ, Sherlock J, Chen YI, et al: Interleukin-23 rather than interleukin-12 is the critical cytokine for autoimmune inflammation of the brain. Nature 421:744-748, 2003
8. Fredriksson T, Pettersson U: Severe psoriasis-oral therapy with a new retinoid. Dermatologica 157:238-244, 1978
9. Gordon KB, Papp KA, Hamilton TK, et al: Efalizumab for patients with moderate to severe plaque psoriasis: A randomized controlled trial. JAMA 290:3073-3080, 2003
10. Gottlieb AB, Matheson RT, Lowe N, et al: A randomized trial of etanercept as monotherapy for psoriasis. Arch Dermatol 139:1627-1632, 2003
11. Greaves MW, Weinstein GD: Treatment of psoriasis. N Engl J Med 332:581-588, 1995
12. Griffiths TW, Griffiths CE, Voorhees JJ: Immunopathogenesis and immunotherapy of psoriasis. Dermatol Clin 13:739-749, 1995
13. Hong K, Chu A, Ludviksson BR, Berg EL, Ehrhardt RO: IL-12, independently of IFN-γ, plays a crucial role in the pathogenesis of a murine psoriasis-like skin disorder. J Immunol 162:7480-7491, 1999
14. Jowitt SN, Yin JA: Psoriasis and bone marrow transplantation. BMJ 300:1398-1399, 1990
15. Kanamori H, Tanaka M, Kawaguchi H, et al: Resolution of psoriasis following allogenic bone marrow transplantation for chronic myelogenous leukemia: Case report and review of the literature. Am J Hematol 71:41-44, 2002
16. Kopp T, Lenz P, Bello-Fernandez C, Kastelein RA, Kupper TS, Stingl G: IL-23 production by cosecretion of endogenous p19 and transgenic p40 in keratin 14/p40 transgenic mice: Evidence for enhanced cutaneous immunity. J Immunol 170:5438-5444, 2003
17. Krueger JG: The immunologic basis for the treatment of psoriasis with new biologic agents. J Am Acad Dermatol 46:1-23, 2002
18. Lebwohl M, Tyring SK, Hamilton TK, et al: A novel targeted T-cell modulator, efalizumab, for plaque psoriasis. N Engl J Med 349:2004-2013, 2003
19. Lee E, Trepicchio WL, Oestreicher JL, et al: Increased expression of interleukin 23 p19 and p40 in lesional skin of patients with psoriasis vulgaris. J Exp Med 199:125-130, 2004
20. Leonardi CL, Powers JL, Matheson RT, et al: Etanercept as monotherapy in patients with psoriasis. N Engl J Med 349:2014-2022, 2003
21. Oppmann B, Lesley R, Blom B, et al: Novel p19 protein engages IL-12p40 to form a cytokine, IL-23, with biological activities similar as well as distinct from IL-12. Immunity 13:715-725, 2000
22. Papp K, Bissonnette R, Krueger JG, et al: The treatment of moderate to severe psoriasis with a new anti-CD11a monoclonal antibody. J Am Acad Dermatol 45:665-674, 2001
23. Trinchieri G: Interleukin-12 and the regulation of innate resistance and adaptive immunity. Nat Rev Immunol 3:133-146, 2003
24. Yawalkar N, Karlen S, Hunger R, Brand CU, Braathen LR: Expression of interleukin-12 is increased in psoriatic skin. J Invest Dermatol 111:1053-1057, 1998