Recombinantly engineered human proteins: Transforming the treatment of psoriasis

Clinical Immunology

Volumn 105, Issue 2, 2002, Pages 105-116

  Gottlieb, Alice B ^a   Bos, Jan D ^b  

^a ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

^b UNIVERSITY OF AMSTERDAM   (Netherlands)

Author keywords

Biologic therapy; Cytokines; Immunopathology; Psoriasis; T cell

Indexed keywords

ALEFACEPT; CD4 ANTIGEN DERIVATIVE; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; DACLIZUMAB; DENILEUKIN DIFTITOX; EFALIZUMAB; ETANERCEPT; GAMMA INTERFERON; INFLIXIMAB; INTERLEUKIN 10; INTERLEUKIN 4; RECOMBINANT DNA; RECOMBINANT PROTEIN; SIPLIZUMAB; TUMOR NECROSIS FACTOR ALPHA;

CELL MIGRATION; CHILL; CHRONIC INFLAMMATION; CYTOKINE PRODUCTION; DAILY LIFE ACTIVITY; DISEASE SEVERITY; FLU LIKE SYNDROME; HEADACHE; HUMAN; IMMUNOPATHOLOGY; IMMUNOSUPPRESSIVE TREATMENT; INFECTION; PATHOGENICITY; PRIORITY JOURNAL; PROTEIN ENGINEERING; PSORIASIS; RECOMBINANT DNA TECHNOLOGY; REMISSION; SHORT SURVEY; T LYMPHOCYTE ACTIVATION;

EID: 0036866646     PISSN: 15216616     EISSN: None     Source Type: Journal    
DOI: 10.1006/clim.2002.5289     Document Type: Review

References (83)

1. Christophers, E., Psoriasis - Epidemiology and clinical spectrum. Clin. Exp. Dermatol. 26, 314-320, 2001.
2. National Psoriasis Foundation, About Psoriasis. Available at http://www.psoriasis.org. Accessed March 2002.
3. Fortune, D. G., Main, C. J., O'Sullivan, T. M., and Griffiths, C. E. M., Quality of life in patients with psoriasis: The contribution of clinical variables and psoriasis-specific stress. Br. J. Dermatol. 137, 755-760, 1997.
4. Linden, K. G., and Weinstein, G. D., Psoriasis: Current perspectives with an emphasis on treatment. Am. J. Med. 107, 595-605, 1999.
5. Krueger, G., Koo, J., Lebwohl, M., Menter, A., Stern, R. S., and Rolstad, T., The impact of psoriasis on quality of life: Results of a 1998 National Psoriasis Foundation patient-membership survey. Arch. Dermatol. 137, 280-284, 2001.
6. Gladman, D. D., and Brockbank, J., Psoriatic arthritis. Expert Opin. Invest. Drugs 9, 1511-1522, 2000.
7. Stern, R. S., Liebman, E. J., and Väkevä, L., Oral psoralen and ultraviolet-A light (PUVA) treatment of psoriasis and persistent risk of nonmelanoma skin cancer. J. Natl. Cancer Inst. 90, 1278-1284, 1998.
8. Stern, R. S., The risk of melanoma in association with long-term exposure to PUVA. J. Am. Acad. Dermatol. 44, 755-761, 2001.
9. Lindelöf, B., Risk of melanoma with psoralen/ultraviolet A therapy for psoriasis. Do the known risks now outweigh the benefits? Drug Safety 20, 289-297, 1999.
10. Zachariae, H., Kragballe, K., and Sogaard, H., Methotrexate induced liver cirrhosis. Br. J. Dermatol. 102, 407, 1980.
11. Perry, W. H., Methotrexate and teratogenesis. Arch. Dermatol. 119, 874-875, 1983.
12. Kono, H., Inokuma, S., Matsuzaki, Y., Nakayama, H., Yamazaki, J., Hishima, T., and Maeda, Y., Two cases of methotrexate induced lymphomas in rheumatoid arthritis: An association with increased serum IgE. J. Rheumatol. 26, 2249-2253, 1999.
13. Zachariae, H., Kragballe, K., Hansen, H. E., Marcussen, N., and Olsen, S., Renal biopsy findings in long-term cyclosporin treatment of psoriasis. Br. J. Dermatol. 136, 531-535, 1997.
14. Lowe, N. J., Wieder, J. M., Rosenbach, A., Johnson, K., Kunkel, R., Bainbridge, C., Bourget, T., Dimov, I., Simpson, K., Glass, E., and Grabie, M. T., Long-term low-dose cyclosporine therapy for severe psoriasis: Effects on renal function and structure. J. Am. Acad. Dermatol. 35, 710-719, 1996.
15. Dimery, I. W., Hong, W. K., Lee, J. J., Guillory-Perez, C., Pham, F., Fritsche, H. A., Jr., and Lippman, S. M., Phase I trial of alpha-tocopherol effects on 13-cis-retinoic acid toxicity. Ann. Oncol. 8, 85-89, 1997.
16. Vahlquist, C., Olsson, A. G., Lindholm, A., and Vahlquist, A., Effects of gemfibrozil (Lopid) on hyperlipidemia in acitretin-treated patients: Results of a double-blind cross-over study. Acta Dermatol. Venereol. 75, 377-380, 1995.
17. Soriatane (Acitretin) Capsules Prescribing Information. Roche Pharmaceuticals, Nutley, NJ, 2002.
18. De Boer, O., Wakelkamp, I., Pals, S., Claessen, N., Bos, J., and Das, P., Increased expression of adhesion receptors in both lesional and non-lesional psoriatic skin. Arch. Dermatol. Res. 286, 304-311, 1994.
19. Gottlieb, A. B., Lifshitz, B., Fu, S. M., Staiano-Coico, L., Wang, C. Y., and 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, 1013-1028, 1986.
20. 389IL-2) suggests a primary immune, but not keratinocyte, pathogenic basis. Nat. Med. 1, 442-447, 1995.
21. Robert, C., and Kupper, T. S., Inflammatory skin diseases, T cells, and immune surveillance. N. Engl. J. Med. 341, 1817-1828, 1999.
22. von Andrian, U. H., and Mackay, C. R., T cell function and migration. N. Engl. J. Med. 343, 1020-1034, 2000.
23. Gottlieb, A. B., Psoriasis: Immunopathology and immunomodulation. Dermatol. Clin. 19, 649-657, 2001.
24. Gottlieb, A. B., Psoriasis. Dis. Manage. Clin. Outcomes 1, 195-202, 1998.
25. Vallat, V. P., Gilleaudeau, P., Battat, L. Wolfe, J., Nabeya, R., Heftler, N., Hodak, E., Gottlieb, A. B., and Krueger, J. B., PUVA bath therapy strongly suppresses immunological and epidermal activation in psoriasis: A possible cellular basis for remittive therapy. J. Exp. Med. 180, 283-296, 1994.
26. +) in both normal and diseased human skin. Arch. Dermatol. Res. 281, 24-30, 1989.
27. De Rie, M. A., Hamerlinck, F., Hintzen, R. Q., Bos, J. D., and Van Lier, R. A., Quantitation of soluble CD27, a T-cell activation antigen, and soluble interleukin-2 receptor in serum from patients with psoriasis. Arch. Dermatol. Res. 283, 533-534, 1991.
28. Friedrich, M., Krammig, S., Henze, M., Döcke, W. D., Sterry, W., and Asadullah, K., Flow cytometric characterization of lesional T cells in psoriasis: Intracellular cytokine and surface antigen expression indicates an activated, memory/effector type 1 immunophenotype. Arch. Dermatol. Res. 292, 519-521, 2000.
29. Wingren, A. G., Parra, E., Varga, M., Kalland, T., Sjögren, H.-O., Hedlund, G., and Dohlsten, M., T cell activation pathways: B7, LFA-3, and ICAM-1 shape unique T cell profiles. Crit. Rev. Immunol. 15, 235-253, 1995.
30. Grakoui, A., Bromley, S. K., Sumen, C., Davis, M. M., Shaw, A. S., Allen, P. M., and Dustin, M. L., The immunological synapse: A molecular machine controlling T cell activation. Science 285, 221-227, 1999.
31. Mosmann, T. R., and Sad, S., The expanding universe of T-cell subsets: Th1, Th2 and more. Immunol. Today 17, 138-146, 1996.
32. Vollmer, S., Menessen, A., Trommler, P., Schendel, D., and Prinz, J. C., T lymphocytes derived from skin lesions of patients with psoriasis vulgaris express a novel cytokine pattern that is distinct from that of T helper type 1 and T helper type 2 cells. Eur. J. Immunol. 24, 2377-2382, 1994.
33. Bos, J. D., and De Rie, M. A., The pathogenesis of psoriasis: Immunological facts and speculations. Immunol. Today 20, 40-46, 1999.
34. Austin, L. M., Ozawa, M., Kikuchi, T., Waiters, I. B., and Krueger, J. G., The majority of epidermal T cells in psoriasis vulgaris lesions can produce type 1 cytokines, interferon-γ, interleukin-2, and tumor necrosis factor-α, defining TC1 (cytotoxic T lymphocyte) and TH1 effector populations: A type 1 differentiation bias is also measured in circulating blood T cells in psoriatic patients. J. Invest. Dermatol. 113, 752-759, 1999.
35. Sticherling, M., Sautier, W., Schroder, J. M., and Christophers, E., Interleukin-8 plays its role at local level in psoriasis vulgaris. Acta Dermatol. Venereol. 79, 4-8, 1999.
36. Miller, G. T., Hochman, P. S., Meier, W., Tizard, R., Bixler, S. A., Rosa, M. D., and Wallner, B. P., Specific interaction of lymphocyte function-associated antigen 3 with CD2 can inhibit T cell responses. J. Exp. Med. 178, 211-222, 1993.
37. I fusion protein on nonhuman primates. Ther. Immunol. 1, 205-216, 1994.
38. Majeau, G. R., Meier, W., Jimmo, B., Kioussis, D., and Hochman, P. S., Mechanism of lymphocyte function-associated molecule 3-Ig fusion proteins inhibition of T cell responses. J. Immunol. 152, 2753-2767, 1994.
39. I fusion protein: Cell line dependent glycosylation effects on pharmacokinetics and pharmacodynamic markers. Ther. Immunol. 2, 159-171, 1995.
40. Sanders, M. E., Makgoba, M. W., Sharrow, S. O., Stephany, D., Springer, T. A., Young, H. A., and Shaw, S., Human memory T lymphocytes express increased levels of three cell adhesion molecules (LFA-3, CD2, and LFA-1) and three other molecules (UCHL1, Cw29, and Pgp-1) and have enhanced IFN-gamma production. J. Immunol. 140, 1401-1407, 1988.
41. + T cells is independent of cell activation. Cell Adhes. Commun. 7, 267-279, 1999.
42. Ellis, C. N., and Krueger, G. G., for the Alefacept Clinical Study Group, Treatment of chronic plaque psoriasis by selective targeting of memory effector T lymphocytes. N. Engl. J. Med. 345, 248-255, 2001.
43. Krueger, G., and Vaishnaw, A., The pharmacodynamic effect of alefacept and its correlation to clinical efficacy in chronic plaque psoriasis. J. Eur. Acad. Dermatol. Venereol. 15, 251, 2001. [Abstract P24-54]
44. + producing T cells in lesional skin. J. Invest. Dermatol. 117, 546, 2001. [Abstract 938]
45. + and CD8+ T cells are selectively reduced by alefacept. J. Invest. Dermatol. 119, 345, 2002.
46. Christophers, E., Bourcier, M., Griffiths, C., Guenther, L., Langley, R., Lebwohl, M., Lowe, N., and Shrager, D., Study design and demographics of a randomized, double-blind, placebo-controlled phase 3 dose-comparison study to evaluate weekly intramuscular administration of alefacept in chronic plaque psoriasis. J. Eur. Acad. Dermatol. Venereol. 15, 249, 2001. [Abstract P24-47]
47. Lebwohl, M., Bissonnette, R., Ellis, C., Gordon, K., Gottlieb, A., Gulliver, W., Korman, N., Krueger, G., Lowe, N., Menter, A., Papp, K., Poulin, Y., Washenik, K., and Shrager, D., Study design and demographics of a randomized, double-blind, placebo-controlled phase 3 study to evaluate weekly IV bolus administration of alefacept in chronic plaque psoriasis. J. Eur. Acad. Dermatol. Venereol. 15, 248-249, 2001. [Abstract P24-46]
48. Krueger, G. G., Efficacy of two courses of intravenous alefacept in patients with chronic plaque psoriasis. J. Invest. Dermatol. 119, 344, 2002.
49. Langley, R., Christophers, E., Lebwohl, M., Efficacy and safety of multiple courses of intramuscular alefacept in patients with chronic plaque psoriasis. J. Invest. Dermatol. 119, 344, 2002.
50. Gottlieb, A. B., Casale, T., Gofe, B., Gordon, K., Korman, N., Lowe, N., Washenik, K., Frankel, E., Roberts, J., and Vaishnaw, A., Impact of a 12-week course of alefacept therapy on primary and secondary immune responses in psoriasis patients. J. Eur. Acad. Dermatol. Venereol. 15, 242, 2001. [Abstract P24-21]
51. 389IL-2, for the treatment of psoriasis. Dermatol. Ther. 5, 48-63, 1998.
52. 389IL-2) in patients with severe psoriasis. J. Am. Acad. Dermatol. 45, 871-881, 2001.
53. Gottlieb, A. B., Lebwohl, M., Shirin, S., Sherr, A., Gilleaudeau, P., Singer, G., Solodkina, G., Grossman, R., Gisoldi, E., Phillips, S., Neisler, H. M., and Krueger, J. G., Anti-CD4 monoclonal antibody treatment of moderate to severe psoriasis vulgaris: Results of a pilot, multicenter, multiple-dose, placebo-controlled study. J. Am. Acad. Dermatol. 43, 595-604, 2000.
54. Abrams, J. R., Lebwohl, M. G., Guzzo, C. A., Jegasothy, B. V., Goldfarb, M. T., Goffe, B. S., Menter, A., Lowe, N. J., Krueger, G., Brown, M. J., Weiner, R. S., Birkhofer, M. J., Warner, G. L., Berry, K. K., Linsley, P. S., Krueger, J. G., Ochs, H. D., Kelley, S. L., and Kang, S., CTLA4Ig-mediated blockade of T-cell costimulation in patients with psoriasis vulgaris. J. Clin. Invest. 103, 1243-1252, 1999.
55. Abrams, J. R., Kelley, S. L., Hayes, E., Kikuchi, T., Brown, M. J., Kang, S., Lebwohl, M. G., Guzzo, C. A., Jegasothy, B. V., Linsley, P. S., and Krueger, J. G., Blockade of T lymphocyte costimulation with cytotoxic T lymphocyte-associated antigen 4-immunoglobulin (CTLA4Ig) reverses the cellular pathology of psoriatic plaques, including the activation of keratinocytes, dendritic cells, and endothelial cells. J. Exp. Med. 192, 681-693, 2000.
56. Schopf, R. E., IDEC-114 (IDEC). Curr. Opin. Invest. Drugs 2, 635-638, 2001.
57. Gottlieb, A. B., Lebwohl, M., Totoritis, M. C., Abdulghani, A. A., Shuey, S. R., Romano, P., Chaudhari, U., Alien, R. S., and 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, 692-700.
58. IDEC Pharmaceuticals Announced Results of Phase I/II Study of IDEC-114 Antibody in Psoriasis. Press release, March 5, 2001.
59. Carswell, C. I., Plosker, G. L., and Wagstaff, A. J., Daclizumab: A review of its use in the management of organ transplantation. BioDrugs 15, 745-773, 2001.
60. Goebel, J., Stevens, E., Forrest, K., and Roszman, T. L., Daclizumab (Zenapax) inhibits early interleukin-2 receptor signal transduction events. Transplant. Immunol. 8, 153-159, 2000.
61. Krueger, J. G., Walters, I. B., Miyazawa, M., Gilleaudeau, P., Hakimi, J., Light, S., Sherr, A., and Gottlieb, A. B., Successful in vivo blockade of CD25 (high-infinity interleukin 2 receptor) on T cells by administration of humanized anti-Tac antibody to patients with psoriasis. J. Am. Acad. Dermatol. 43, 448-458, 2000.
62. Gottlieb, A. B., Krueger, J. G., Bright, R., Ling, M., Lebwohl, M., Kang, S., Feldman, S., Spellman, M., Wittkowski, K., Ochs, H. D., Jardieu, P., Bauer, R., White, M., Dedrick, R., and Garovoy, M., Effects of administration of a single dose of a humanized monoclonal antibody to CD11a on the immunobiology and clinical activity of psoriasis. J. Am. Acad. Dermatol. 42, 428-435, 2000.
63. 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., and Garovoy, M. R., The treatment of moderate to severe psoriasis with a new anti-CD11a monoclonal antibody. J. Am. Acad. Dermatol. 45, 665-674, 2001.
64. Bauer, R. J., Dedrick, R. L., White, M. L., Murray, M. J., and Garovoy, M. R., Population pharmacokinetics and pharmacodynamics of the efalizumab antibody in human subjects with psoriasis. J. Pharmacokinet. Biopharm. 27, 397-420, 1999.
65. Gottlieb, A. B., Krueger, J. G., Wittkowski, K., Dedrick, R., Walicke, P. A., and Garovoy, M., Psoriasis as a model for T-cell-mediated disease: Immunobiologic and clinical effects of treatment with multiple doses of efalizumab, an anti-CD11a antibody. Arch. Dermatol. 138, 591-600, 2002.
66. Gordon, K. B., Leonardi, C., Tyring, S., Gottlieb, A., Walicke, P., Dummer, W., and Papp, K., Efalizumab (anti-CD11a) is safe and effective in the treatment of psoriasis: Pooled results of the 12-week first treatment period from 2 phase III trials. J. Invest. Dermatol. 110, 242, 2002.
67. Langley, R., Roenigk, H., and Dingivan, C., Safety, tolerance, and disease activity of MEDI-507 for the treatment of moderate to severe psoriasis: A review of phase I results. In "2nd Joint Meeting International Psoriasis Symposium and European Congress on Psoriasis," June 19-24, 2001. Plenary 7.
68. MedImmune R & D Pipeline. Available at http://www.medimmune.com. Accessed March 2002.
69. Asadullah, K., Sterry, W., Stephanek, K., Jasulaitis, D., Leupold, M., Audring, H., Volk, H. D., and Docke, W. D., IL-10 is a key cytokine in psoriasis. J. Clin. Invest. 101, 783-794, 1998.
70. Trepicchio, W. L., Ozawa, M., Walters, I. B., Kikuchi, T., Gilleaudeau, P., Bliss, J. L., Schwertschlag, U., Dorner, A. J., and Krueger, J. G., Interleukin-11 therapy selectively downregulates type 1 cytokine proinflammatory pathways in psoriasis lesions. J. Clin. Invest. 104, 1527-1537, 1999.
71. Kimball, A., Kawamura, T., Turner, M., and Blauvelt, A., Randomized double-blind placebo-controlled trial using interleukin-10 for psoriasis. J. Invest. Dermatol. 117, 546, 2001. [Abstract 937]
72. Ghoreschi, R., Thomas, P., Breit, S., Biedermann, T., Prinz, J., Sander, C., Plewig, G., and Rochen, M., Interleukin 4-induced immune deviation as therapy for psoriasis. J. Invest. Dermatol. 117, 465, 2001. [Abstract 453]
73. Scallon, B. J., Moore, M. A., Trinh, H., Knight, D. M., and Ghrayeb, J., Chimeric anti-TNF-alpha monoclonal antibody cA2 binds recombinant transmembrane TNF-alpha and activates immune effector functions. Cytokine 7, 251-259, 1995.
74. Oh, C. J., Das, K. M., and Gottlieb, A. B., Treatment with anti-tumor necrosis factor-alpha (TNF-alpha) monoclonal antibody dramatically decreases the clinical activity of psoriasis lesions. J. Am. Acad. Dermatol. 42, 829-830, 2000.
75. Chaudhari, U., Romano, P., Mulcahy, L. D., Dooley, L. T., Baker, D. G., and Gottlieb, A. B., Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: A randomised trial. Lancet 357, 1842-1847, 2001.
76. Gottlieb, A. B., Masud, S., Ramamurthi, R., Abdulghani, P., Romano, P., Chaudhari, U., Dooley, L. T., Fasanmade, A. A., Wagner, C. L., Pharmacodynamic and pharmacokinetic response to anti-tumor necrosis factor-alpha monoclonal antibody (Infliximab) treatment of moderate to severe psoriasis vulgaris, J. Amer. Acad. Dermatol., in press.
77. Scallon, B. J., Cai, A., Shealy, D., Solowski, N., Song, X., and Wagner, C., New comparisons of two types of TNF α antagonists approved for rheumatoid arthritis. Arthritis Rheum. 43, S226, 2000.
78. Mease, P. J., Goffe, B. S., Metz, J., Vanderstoep, A., Finck, B., and Burge, D. J., Etanercept in the treatment of psoriatic arthritis and psoriasis: A randomised trial. Lancet 356, 385-390, 2000.
79. Mease, P., Kivitz, A., Burch, F., Siegel, E., Cohen, S., and Burge, D., Improvement in disease activity in patients with psoriatic arthritis receiving etanercept (Enbrel): Results of a phase 3 multicenter clinical trial. Arthritis Rheum. 44, S90, 2001.
80. Gottlieb, A. B., Matheson, R. T., Lowe, N., Zitnik, R. J., Efficacy of Enbrel in patients with psoriasis J. Invest. Dermatol. 119, 234, 2002.
81. Remicade (Infliximab) Recombinant for IV Injection Prescribing Information. Centocor, Inc., Malvern, PA, 2002.
82. Enbrel (Etanercept) Prescribing Information. Immunex Corp., Seattle, WA, 2002.
83. Keane, J., Gershon, S., Wise, R. P., Mirabile-Levens, E., Kasznica, J., Schwieterman, W. D., Siegel, J. N., and Braun, M. M., Tuberculosis associated with infliximab, a tumor necrosis factor α-neutralizing agent. N. Engl. J. Med. 345, 1098-1104, 2001.