Evaluation of safety and clinical activity of multiple doses of the anti-CD80 monoclonal antibody, galiximab, in patients with moderate to severe plaque psoriasis

Clinical Immunology

Volumn 111, Issue 1, 2004, Pages 28-37

  Gottlieb, Alice B ^a   Kang, Sewon ^b   Linden, Kenneth G ^c   Lebwohl, Mark ^d   Menter, Alan ^e   Abdulghani, Ahsan A ^a   Goldfarb, Michael ^b   Chieffo, Nicole ^f   Totoritis, Mark C ^f  

^a ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

^b UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^e BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^f BIOGEN   (United States)

Author keywords

ADCC; Adverse event; AE; Antibody dependent, cell mediated cytotoxicity; Antigen presenting cells; APCs; Area under the curve; AUC; CDC; Complement dependent cytotoxicity; CTLA 4; Cytotoxic T lymphocyte associated antigen 4; Galiximab; ICAM 1; PASI; Psoriasis

Indexed keywords

ANTIPSORIASIS AGENT; GALIXIMAB; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY CD 80; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; CELL COUNT; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOSE RESPONSE; DRUG HALF LIFE; DRUG SAFETY; DYSURIA; FEMALE; FEVER; HEADACHE; HOSPITALIZATION; HUMAN; HYPERTENSION; INFECTION; MALE; MULTIPLE DRUG DOSE; MYALGIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; PSORIASIS VULGARIS; RATING SCALE; T LYMPHOCYTE ACTIVATION;

ADULT; ANTIBODIES, MONOCLONAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; IMMUNOHISTOCHEMISTRY; INJECTIONS, INTRAVENOUS; KERATINOCYTES; MALE; MIDDLE AGED; PSORIASIS; SKIN; TREATMENT OUTCOME;

EID: 1842735276     PISSN: 15216616     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.clim.2004.01.006     Document Type: Article

References (25)

1. Gottlieb A.B., Lifshitz B., Fu S.M., Staiano-Coico L., Wang C.Y., Carter D.M. Expression of HLA-DR molecules by keratinocytes, and presence of Langerhans cells in the dermal infiltrate of active psoriatic plaques. J. Exp. Med. 164:1986;1013-1028.
2. Gottlieb S., Gilleaudeau P., Johnson R., Estes L., Woodworth T., Gottlieb A., Krueger J. Response of psoriasis to a lymphocyte-selective toxin (DAB389IL-2) suggests a primary immune, but not keratinocyte, pathogenic basis. Nat. Med. 1:1995;442-447.
3. Bretscher P., Cohn M. A theory of self-nonself discrimination. Science. 169:1970;1042-1049.
4. Bretscher P.A. A two-step, two-signal model for the primary activation of precursor helper T cells. Proc. Natl. Acad. Sci. U. S. A. 96:1999;185-190.
5. Chambers C.A., Allison J.P. Costimulatory regulation of T cell function. Curr. Opin. Cell Biol. 11:1999;203-210.
6. Dong H., Zhu G., Tamada K., Chen L. B7-H1, a third member of the B7 family, co-stimulates T-cell proliferation and interleukin-10 secretion. Nat. Med. 5:1999;1365-1369.
7. Wang S., Zhu G., Chapoval A.I., Dong H., Tamada K., Ni J., Chen L. Costimulation of T cells by B7-H2, a B7-like molecule that binds ICOS. Blood. 96:2000;2808-2813.
8. Chapoval A.I., Ni J., Lau J.S., Wilcox R.A., Flies D.B., Liu D., Dong H., Sica G.L., Zhu G., Tamada K., Chen L. B7-H3: a costimulatory molecule for T cell activation and IFN-gamma production. Nat. Immunol. 2:2001;269-274.
9. Nickoloff B.J., Mitra R.S., Lee K., Turka L.A., Green J., Thompson C., Shimizu Y. Discordant expression of CD28 ligands, BB-1, and B7 on keratinocytes in vitro and psoriatic cells in vivo. Am. J. Pathol. 142:1993;1029-1040.
10. Newman R., Alberts J., Anderson D., Carner K., Heard C., Norton F., Raab R., Reff M., Shuey S., Hanna N. "Primatization" of recombinant antibodies for immunotherapy of human diseases: a macaque/human chimeric antibody against human CD4. Biotechnology. 10:1992;1455-1460.
11. Gottlieb A.B., Lebwohl M., Totoritis M.C., Abdulghani A.A., Shuey S.R., Romano P., Chaudhari U., Allen R.S., Lizambri R.G. Clinical and histologic response to single-dose treatment of moderate to severe psoriasis with an anti-CD80 monoclonal antibody. J. Am. Acad. Dermatol. 47:2002;692-700.
12. Perkins W., Williams R.E., Vestey J.P., Tidman M.J., Layton A.M., Cunliffe W.J., Saihan E.M., Klaber M.R., Manna V.K., Baker H. A multicentre 12-week open study of a lipid-soluble folate antagonist, piritrexim in severe psoriasis. Br. J. Dermatol. 129:1993;584-589.
13. Fredriksson T., Pettersson U. Severe psoriasis - Oral therapy with a new retinoid. Dermatologica. 157:1978;238-244.
14. Gallon L., Chandraker A., Issazadeh S., Peach R., Linsley P., Turka L., Sayegh M., Khoury S. Differential effects of B7-1 blockade in the rat experimental autoimmune encephalomyelitis model. J. Immunol. 159:1997;4212-4216.
15. Herold K., Vezys V., Koons A., Lenschow D., Thompson C., Bluestone J. CD28/B7 costimulation regulates autoimmune diabetes induced with multiple low doses of streptozotocin. J. Immunol. 158:1997;984-991.
16. Kuchroo V., Das M., Brown J., Ranger A., Zamvil S., Sobel R., Weiner H., Nabavi N., Glimcher L. B7-1 and B7-2 costimulatory molecules activate differentially the Th1/Th2 developmental pathways: application to autoimmune disease therapy. Cell. 80:1995;707-718.
17. Lenschow D., Ho S., Sattar H., Rhee L., Gray G., Nabavi N., Herold K., Bluestone J. Differential effects of anti-B7-1 and anti-B7-2 monoclonal antibody treatment on the development of diabetes in the nonobese diabetic mouse. J. Exp. Med. 181:1995;1145-1155.
18. Nakajima A., Azuma M., Kodera S., Nuriya S., Terashi A., Abe M., Hirose S., Shirai T., Yagita H., Okumura K. Preferential dependence of autoantibody production in murine lupus on CD86 costimulatory molecule. Eur. J. Immunol. 25:1995;3060-3069.
19. Waterhouse P., Penninger J., Timms E., Wakeham A., Shahinian A., Lee K., Thompson C., Griesser H., Mak T. Lymphoproliferative disorders with early lethality in mice deficient in CTLA-4. Science. 270:1995;985-988.
20. Hariharan K., Anderson D., Leigh B., Berquist L.G., Murphy T., Leonard J.E., Braslawsky G.R., Hanna N. Therapeutic activity of IDEC-114 (anti-CD80) and rituximab (Rituxan®) in B-cell lymphoma. Blood. 98:2001;608a.
21. Nickoloff B., Nestle F., Zheng X., Turka L. T Lymphocytes in skin lesions of psoriasis and mycosis fungoides express B7-1: a ligand for CD28. Blood. 83:1994;2580-2586.
22. Denfeld R.W., Kind P., Sontheimer R.D., Schopf E., Simon J.C. In situ expression of B7 and CD28 receptor families in skin lesions of patients with lupus erythematosus. Arthritis Rheum. 40:1997;814-821.
23. Papp K., Bissonnette R., Krueger J.G., Carey W., Gratton D., Gulliver W.P., Lui H., Lynde C.W., Magee A., Minier D., Ouellet J.P., Patel P., Shapiro J., Shear N.H., Kramer S., Walicke P., Bauer R., Dedrick R.L., Kim S.S., White M., Garovoy M.R. The treatment of moderate to severe psoriasis with a new anti-CD11a monoclonal antibody. J. Am. Acad. Dermatol. 45:2001;665-674.
24. Ellis C.N., Krueger G.G. Treatment of chronic plaque psoriasis by selective targeting of memory effector T lymphocytes. N. Engl. J. Med. 345:2001;248-255.
25. Abrams J., Lebwohl M., Guzzo C., Jegasothy B., Goldfarb M., Goffe B., Menter A., Lowe N., Krueger G., Brown M., Weiner R., Birkhofer M., Warner G., Berry K., Linsley P., Krueger J., Ochs H., Kelley S., Kang S. CTLA4Ig-mediated blockade of T-cell costimulation in patients with psoriasis vulgaris. J. Clin. Invest. 103:1999;1243-1252.