Biological agents in the treatment of psoriasis

Giornale Italiano di Dermatologia e Venereologia

Volumn 143, Issue 5, 2008, Pages 315-327

  Tzu, J ^a   Krulig, E ^b   Cardenas, V ^b   Kerdel, F A ^c  

^a UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^b Florida Academic Dermatology Centers   (United States)

^c UNIVERSITY OF MIAMI HOSPITAL   (United States)

Author keywords

Biological products; Psoriasis; Skin diseases

Indexed keywords

ABT 874; ADALIMUMAB; ALEFACEPT; CNTO 1275; CYCLOSPORIN; EFALIZUMAB; ETANERCEPT; ETRETIN; FOLIC ACID; HYDROXYUREA; INFLIXIMAB; INTERCELLULAR ADHESION MOLECULE 1; ISONIAZID; LEFLUNOMIDE; METHOTREXATE; METHOXSALEN; MONOCLONAL ANTIBODY; PLACEBO; SALAZOSULFAPYRIDINE; TIOGUANINE;

ALKALINE PHOSPHATASE BLOOD LEVEL; ANTIGEN PRESENTING CELL; ARTHRALGIA; ASPERGILLOSIS; CARDIOVASCULAR DISEASE; CHILL; CLINICAL TRIAL; COLON ADENOCARCINOMA; CONGESTIVE HEART FAILURE; CONTINUOUS INFUSION; COUGHING; CRYPTOCOCCOSIS; DEMYELINATING DISEASE; DISEASE SEVERITY; DRUG CONTRAINDICATION; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG INDICATION; DRUG INTERACTION; DRUG SAFETY; DRUG TARGETING; DRUG TREATMENT FAILURE; DYSPEPSIA; EOSINOPHILIA; FATIGUE; FEVER; GRANULOMA; HEADACHE; HELPER CELL; HEMOLYTIC ANEMIA; HEPATITIS; HISTOPLASMOSIS; HOSPITAL INFECTION; HUMAN; HYPERSENSITIVITY; HYPERTENSION; INFECTION; INFLUENZA; INJECTION SITE REACTION; JAUNDICE; LEUKEMIA; LEUKOCYTOSIS; LEUKOPENIA; LISTERIOSIS; LIVER DYSFUNCTION; LIVER FAILURE; LIVER TOXICITY; LOADING DRUG DOSE; LUPUS LIKE SYNDROME; LYMPHOCYTOPENIA; LYMPHOMA; LYMPHOPROLIFERATIVE DISEASE; MALIGNANT TRANSFORMATION; MELANOMA; MEMORY T LYMPHOCYTE; MYALGIA; MYCOSIS; NAUSEA; NEPHROTOXICITY; PANCYTOPENIA; PAPULAR RASH; PATHOGENESIS; PRURITUS; PSORIASIS; PSORIASIS VULGARIS; PUVA; RECOMMENDED DRUG DOSE; REVIEW; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE DRUG DOSE; SINUSITIS; SKIN CANCER; SOLID TUMOR; T LYMPHOCYTE; TERATOGENESIS; TH17 CELL; THROMBOCYTOPENIA; TRIACYLGLYCEROL BLOOD LEVEL; TUBERCULOSIS; ULTRAVIOLET A RADIATION; UPPER RESPIRATORY TRACT INFECTION;

EID: 55949113925     PISSN: 03920488     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (71)

1. Krueger JG, Bowcock A. Psoriasis pathophysiology: current concepts of pathogenesis. Ann Rheum Dis 2005;64(Suppl 2):ii30-6.
2. Van de Kerkhof PC. Consistent control of psoriasis by continuous long-term therapy: the promise of biological treatments. J Eur Acad Dermatol Venereol 2006;20:639-65.
3. Krueger G, Koo J, Lebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation Patient-Membership Survey. Arch Dermatol 2001;137:280-4.
4. Rapp SR, Feldman SR, Exum ML, Fleischer AB Jr, Reboussin DM. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol 1999;41:401-7.
5. Smith CH, Anstey AV, Barker JN, Burden AD, Chalmers RJ, Chandler D et al. British Association of Dermatologists guidelines for use of biological interventions in psoriasis 2005. Br J Dermatol 2005;153:486-97.
6. Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon KB et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol 2008;58:826-50.
7. Sauder DN, Mamelak AJ. Understanding the new clinical landscape for psoriasis: a comparative review of biologics. J Cutan Med Surg 2004;8:205-12.
8. Pittelkow MR, Perry HO, Muller SA, Maughan WZ, O'Brien PC. Skin cancer in patients with psoriasis treated with coal tar. A 25-year follow-up study. Arch Dermatol 1981;117:465-8.
9. Menter A, Griffiths CE. Current and future management of psoriasis. Lancet 2007;370:272-84.
10. Nijsten TE, Stern RS. The increased risk of skin cancer is persistent after discontinuation of psoralen+ultraviolet A: a cohort study. J Invest Dermatol 2003;121:252-8.
11. Stern RS, Bagheri S, Nichols K. The persistent risk of genital tumors among men treated with psoralen plus ultraviolet A (PUVA) for psoriasis. J Am Acad Dermatol 2002;47:33-9.
12. Stern RS. Psoralen and ultraviolet a light therapy for psoriasis. N Engl J Med 2007;357:682-90.
13. Strober BE, Siu K, Menon K. Conventional systemic agents for psoriasis. A systematic review. J Rheumatol 2006;33:1442-6.
14. Tzu J MA, Sauder DN. Current advancements in the treatment of psoriasis: immunobiologic agents. Clinical and Applied Immunology Reviews 2006;6:99-130.
15. Mascelli MA, Mascelli MA, Zhou H, Sweet R, Getsy J, Davis HM, Graham M et al. Molecular, biologic, and pharmacokinetic properties of monoclonal antibodies: impact of these parameters on early clinical development. J Clin Pharmacol 2007;47:553-65.
16. da Silva AJ, Brickelmaier M, Majeau GR, Li Z, Su L, Hsu YM et al. Alefacept, an immunomodulatory recombinant LFA-3/lgG1 fusion protein, induces CD 16 signaling and CD2/CD16-dependent apoptosis of CD2(+) cells. J Immunol 2002;168:4462-71.
17. Gottlieb AB, Casale TB, Frankel E, Goffe B, Lowe N, Ochs HD et al. CD4+ T-cell-directed antibody responses are maintained in patients with psoriasis receiving alefacept: results of a randomized study. J Am Acad Dermatol 2003;49:816-25.
18. Hodak E, David M. Alefacept: a review of the literature and practical guidelines for management. Dermatol Ther 2004;17:383-92.
19. Biogen. [cited September 2008]. Available at: http://www.amevive.com/pdf/ AMEVIVEPI.pdf. See package insert.
20. Lebwohl M, Christophers E, Langley R, Ortonne JP, Roberts J, Griffiths CE; Alefacept Clinical Study Group. An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis. Arch Dermatol 2003;139:719-27.
21. Goffe B, Papp K, Gratton D, Krueger GG, Darif M, Lee S et al. An integrated analysis of thirteen trials summarizing the long-term safety of alefacept in psoriasis patients who have received up to nine courses of therapy. Clin Ther 2005;27:1912-21.
22. Gottlieb AB, Krueger JG, Wittkowski K, Dedrick R, Walicke PA, 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 2002;138:591-600.
23. Shear NH, Langley RG, Ho V. Efalizumab, a reversible T-cell modulator for psoriasis. J Cutan Med Surg 2006;9(Suppl 1):4-9.
24. Boehncke WH, Prinz J, Gottlieb AB. Biologic therapies for psoriasis. A systematic review. J Rheumatol 2006;33:1447-51.
25. Fretzin S, Crowley J, Jones L, Young M, Sobell J. Successful treatment of hand and foot psoriasis with efalizumab therapy. J Drugs Dermatol 2006;5:838-46.
26. Cohen DJ, Scherschun L. Case reports: practical experience with efalizumab in hand and foot psoriasis. J Drugs Dermatol 2007;6:1224-30.
27. Leonardi C, Sobell J, Sofen H and Krell J. Phase IV study to evaluate the safety and efficacy of efalizumab for treatment of hand and foot psoriasis. J Am Acad Dermatol 2007;56.
28. Papp KA, Caro I, Leung HM, Garovoy M, Mease PJ. Efalizumab for the treatment of psoriatic arthritis. J Cutan Med Surg 2007;11:57-66.
29. Nast A, Kopp I, Augustin M, Banditt KB, Boehncke WH, Follmann M et al. German evidence-based guidelines for the treatment of Psoriasis vulgaris (short version). Arch Dermatol Res 2007;299:111-38.
30. Vugmeyster Y, Kikuchi T, Lowes MA, Chamian F, Kagen M, Gilleaudeau P et al. Efalizumab (anti-CD11a)-induced increase in peripheral blood leukocytes in psoriasis patients is preferentially mediated by altered trafficking of memory CD8+ T cells into lesional skin. Clin Immunol 2004;113:38-46.
31. Gordon KB, Papp KA, Hamilton TK, Walicke PA, Dummer W, Li N et al. Efalizumab for patients with moderate to severe plaque psoriasis: a randomized controlled trial. JAMA 2003;290:3073-80.
32. Menter A, Gordon K, Carey W, Hamilton T, Glazer S, Caro I et al. Efficacy and safety observed during 24 weeks of efalizumab therapy in patients with moderate to severe plaque psoriasis. Arch Dermatol 2005;141:31-8.
33. Gottlieb AB, Hamilton T, Caro I, Kwon P, Compton PG, Leonardi CL; Efalizumab Study Group. Long-term continuous efalizumab therapy in patients with moderate to severe chronic plaque psoriasis: updated results from an ongoing trial. J Am Acad Dermatol 2006;54:S154-63.
34. Pirzada S, Tomi Z, Gulliver W. A review of biologic treatments for psoriasis with emphasis on infliximab. Skin Therapy Lett 2007;12:1-4.
35. Langley RG, Carey WP, Rafal ES, Tyring SK, Caro I, Wang X et al. Incidence of infection during efalizumab therapy for psoriasis: analysis of the clinical trial experience. Clin Ther 2005;27:1317-28.
36. Papp KA, et al. Strategies for optimizing treatment with efalizumab in moderate to severe psoriasis. J Cutan Med Surg 2006;9(Suppl 1):26-32.
37. Leonardi CL, Toth D, Cather JC, Langley RG, Werther W, Compton P et al. A review of malignancies observed during efalizumab (Raptiva) clinical trials for plaque psoriasis. Dermatology 2006;213:204-14.
38. White JM, Smith CH, Robson A, Ash G, Barker JN. DRESS syndrome caused by efalizumab. Clin Exp Dermatol 2008;33:50-2.
39. Graves JE, Nunley K, Heffernan MP. Off-label uses of biologics in dermatology: rituximab, omalizumab, infliximab, etanercept, adalimumab, efalizumab, and alefacept (part 2 of 2). J Am Acad Dermatol 2007;56:e55-79.
40. Partsch G, Steiner G, Leeb BF, Dunky A, Bröil H, Smolen JS. Highly increased levels of tumor necrosis factor-alpha and other proinflammatory cytokines in psoriatic arthritis synovial fluid. J Rheumatol 1997;24:518-23.
41. Ettehadi P, Greaves MW, Wallach D, Aderka D, Camp RD. Elevated tumour necrosis factor-alpha (TNF-alpha) biological activity in psoriatic skin lesions. Clin Exp Immunol 1994;96:146-51.
42. Brounell I. Sexy and 17: TH17 effector T cells and psoriasis. J Drugs Dermatol 2007;6:853-6.
43. Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA 2006;295:2275-85.
44. Bissonnette R. Etanercept for the treatment of psoriasis. Skin Therapy Lett 2006;11:1-4.
45. Cohen JD, Bournerias I, Buffard V, Paufler A, Chevalier X, Bagot M et al. Psoriasis induced by tumor necrosis factor-alpha antagonist therapy: a case series. J Rheumatol 2007;34:380-5.
46. Goiriz R, Dauden E, Perez-Gala S, Guhl G, Garcia-Diez A. Flare and change of psoriasis morphology during the course of treatment with tumour necrosis factor blockers. Clin Exp Dermatol 2007;32:176-9.
47. Furst DE, Wallis R, Broder M, Beenhouwer DO. Tumor necrosis factor antagonists: different kinetics and/or mechanisms of action may explain differences in the risk for developing granulomatous infection. Semin Arthritis Rheum 2006;36:159-67.
48. Tyring S, Gottlieb A, Papp K, Gordon K, Leonardi C, Wang A et al. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. Lancet 2006;367:29-35.
49. Calabrese LH, Zein N. Biologic agents and liver toxicity: an added concern or therapeutic opportunity? Nat Clin Pract Rheumatol 2007;3:422-3.
50. Tyring S, Gordon KB, Poulin Y, Langley RG, Gottlieb AB, Dunn M et al. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol 2007;143:719-26.
51. Moore A, Gordon KB, Kang S, Gottlieb A, Freundlich B, Xia HA et al. A randomized, open-label trial of continuous versus interrupted etanercept therapy in the treatment of psoriasis. J Am Acad Dermatol 2007;56:598-603.
52. Sanchez Carazo JL, Mahiques Santos L, Oliver Martinez V. Safety of etanercept in psoriasis: a critical review. Drug Saf 2006;29:675-85.
53. Amgen [cited September 2008]. Available at: http://www.enbrel.com/pdf/ enbrel_pi.pdf. See package insert.
54. Scallon B, Cai A, Solowski N, Rosenberg A, Song XY, Shealy D et al. Binding and functional comparisons of two types of tumor necrosis factor antagonists. J Pharmacol Exp Ther 2002;301:418-26.
55. Centocor [cited September 2008]. Available at: http://www.remicade.com/ remicade/assets/HCP_PPI.pdf. See package insert.
56. Reich K, Nestle FO, Papp K, Ortonne JP, Evans R, Guzzo C et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet 2005;366:1367-74.
57. Menter A, et al. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol 2007;56:31.
58. Baert F, Noman M, Vermeire S, Van Assche G, D' Haens G, Carbonez A et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med 2003;348:601-8.
59. Ting PT, Koo JY. Use of etanercept in human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) patients. Int J Dermatol 2006;45:689-92.
60. Hamilton CD. Infectious complications of treatment with biologic agents. Curr Opin Rheumatol 2004;16:393-8.
61. Thomas VD, Yang FC, Kvedar JC. Biologics in psoriasis: a quick reference guide. J Am Acad Dermatol 2005;53:346-51.
62. Abbott [cited September 2008]. Available at: http://www.rxabbott.com/pdf/ humira.pdf. See package insert.
63. Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon KB et al. Guidelines for the management of psoriasis and psoriatic arthritis. Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol 2008;58:826-50.
64. Menter A, Tyring SK, Gordon K, Kimball AB, Leonardi CL, Langley RG et al. Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial. J Am Acad Dermatol 2008;58:106-15.
65. Gordon KB, Tyring S, Gu Y, Okun M. Psoriasis patients treated continuosly with adalimumab: Efficacy and safety results from months 12 to 18. J Am Acad Dermatol 2008;58:AB129.
66. Saurat JH, Stingl G, Dubertret L, Papp K, Langley RG, Ortonne JP et al. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). Br J Dermatol 2008;158:558-66.
67. Mrowietz U, Luger T, Gu Y, Okun M. Methotrexate-treated psoriasis patients transitioning to adalimumab: Efficacy and safety outcomes. J Am Acad Dermatol 2008;58:AB120.
68. Scheinfeld N. Adalimumab: a review of side effects. Expert Opin Drug Saf 2005;4:637-41.
69. Papp KA, Langley RG, Lebwohl M, Krueger GG, Szapary P, Yeilding N et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet 2008;371:1675-84.
70. Leonardi CL, Kimball AB, Papp KA, Yeilding N, Guzzo C, Wang Y et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet 2008;371:1665-74.
71. Gordon KB et al. ABT-874 in Psoriasis: Phase II Study Results. Paper presented at World Congress of Dermatology. Buenos Aires, Argentina, 2007.