Safety of efalizumab in patients with moderate to severe chronic plaque psoriasis: Review of clinical data. Part II

Journal of Cutaneous Medicine and Surgery

Volumn 9, Issue 6, 2005, Pages 313-323

  Papp, Kim A ^a,g   Camisa, Charles ^b   Stone, Stephen P ^c   Caro, Ivor ^d   Wang, Xiaolin ^d   Compton, Peter ^d   Walicke, Patricia A ^e   Gottlieb, Alice B ^f  

^a UNIVERSITY OF WESTERN ONTARIO   (Canada)

^b DEPARTMENT OF COLORECTAL SURGERY   (United States)

^c SOUTHERN ILLINOIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d GENENTECH INC   (United States)

^e Rinat Neuroscience Corporation   (United States)

^f ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

^g PROBITY MEDICAL RESEARCH   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID; CYCLOSPORIN; EFALIZUMAB; ETRETIN; METHOTREXATE; PLACEBO; PSORALEN; RETINOID;

ALLERGIC REACTION; ANAPHYLAXIS; ANGIONEUROTIC EDEMA; ARTHRALGIA; ARTHRITIS; ASTHENIA; BACKACHE; BRONCHITIS; CANCER; CARDIOVASCULAR DISEASE; CHILL; CLINICAL TRIAL; DATA ANALYSIS; DEPRESSION; DIGESTIVE SYSTEM DISEASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ENDOCRINE DISEASE; ERYTHRODERMA; FEVER; FLU LIKE SYNDROME; GASTROENTERITIS; HEADACHE; HEMATOLOGIC DISEASE; HERPES SIMPLEX; HISTOPLASMOSIS; HUMAN; HYPERLIPIDEMIA; HYPERSENSITIVITY; HYPERTENSION; INFECTION; INJECTION SITE PAIN; INJECTION SITE REACTION; LEUKEMIA; LIVER CIRRHOSIS; LIVER FIBROSIS; LYMPHOMA; LYMPHOPROLIFERATIVE DISEASE; MELANOMA; MUSCULOSKELETAL DISEASE; MYALGIA; NAUSEA; NEPHROTOXICITY; NEUROLOGIC DISEASE; PAIN; PRIORITY JOURNAL; PSORIASIS; PSORIASIS VULGARIS; PUSTULAR PSORIASIS; PUSTULOSIS PALMOPLANTARIS; RESPIRATORY TRACT DISEASE; REVIEW; RHEUMATOID ARTHRITIS; RISK ASSESSMENT; SKIN CANCER; SKIN DISEASE; SOLID TUMOR; TERATOGENICITY; THROMBOCYTOPENIA; TOXOPLASMOSIS; TUBERCULOSIS; UPPER RESPIRATORY TRACT INFECTION; UROGENITAL TRACT DISEASE; URTICARIA; VIRUS INFECTION; VOMITING;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; CHRONIC DISEASE; CLINICAL TRIALS, PHASE I; CLINICAL TRIALS, PHASE II; DATA INTERPRETATION, STATISTICAL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INJECTIONS, INTRAVENOUS; INJECTIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; PLACEBOS; PSORIASIS; RANDOMIZED CONTROLLED TRIALS; SAFETY; TIME FACTORS;

EID: 33749330192     PISSN: 12034754     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10227-005-0117-0     Document Type: Review

References (27)

1. Koo J. Population-based epidemiologic study of psoriasis with emphasis on quality of life assessment. Dermatol Clin 1996; 14:485-496.
2. Tristani-Firouzi P, Krueger GG. Efficacy and safety of treatment modalities for psoriasis. Cutis 1998; 61:11-21.
3. Lebwohl M, Ellis C, Gottlieb A, et al. Cyclosporine consensus conference: with emphasis on the treatment of psoriasis. J Am Acad Dermatol 1998; 39:464-475.
4. Gottlieb AB. Psoriasis. Dis Manag Clin Outcomes 1998; 1:195-202.
5. Wollina U, Stander K, Barta U. Toxicity of methotrexate treatment in psoriasis and psoriatic arthritis - short- and long-term toxicity in 104 patients. Clin Rheumatol 2001; 20:406-410.
6. 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; 121:252-258.
7. Lebwohl M, Ali S. Treatment of psoriasis. Part 2. Systemic therapies. J Am Acad Dermatol 2001; 45:649-661.
8. Weinstein GD, White GM. An approach to the treatment of moderate to severe psoriasis with rotational therapy. J Am Acad Dermatol 1993; 28:454-459.
9. Griffiths CE, Dubertret L, Ellis CN, et al. Ciclosporin in psoriasis clinical practice: an international consensus statement. Br J Dermatol 2004; 150(suppl 67):11-23.
10. Singri P, West DP, Gordon KB. Biologic therapy for psoriasis: the new therapeutic frontier. Arch Dermatol 2002; 138:657-663.
11. Werther WA, Gonzalez TN, O-Connor SJ, et al. Humanization of an anti-lymphocyte function-associated antigen (LFA)-1 monoclonal antibody and reengineering of the humanized antibody for binding to rhesus LFA-1. J Immunol 1996; 157:4986-4995.
12. Gottlieb A, Krueger JG, Bright R, et al. 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 2000; 42:428-435.
13. Gottlieb AB, Krueger JG, Wittkowski K, et al. 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.
14. 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 2001; 45:665-674.
15. Gottlieb AB, Miller B, Lowe N, et al. Subcutaneously administered efalizumab (anti-CD11a) improves signs and symptoms of moderate to severe plaque psoriasis. J Cutan Med Surg 2003; 7:198-207.
16. Leonardi CL, Papp KA, Gordon KB, et al. Extended efalizumab therapy improves chronic plaque psoriasis: results from a randomized phase III trial. J Am Acad Dermatol 2005; 52:425-433.
17. Lebwohl M, Tyring SK, Hamilton TK, et al. A novel targeted T-cell modulator, efalizumab, for plaque psoriasis. N Engl J Med 2003; 349:2004-2013.
18. Gottlieb AB, Gordon KB, Lebwohl MG, et al. Extended efalizumab therapy sustains efficacy without increasing toxicity in patients with moderate to severe chronic plaque psoriasis. J Drugs Dermatol 2004; 3:614-624.
19. Gordon KB, Papp KA, Hamilton TK, et al. Efalizumab for patients with moderate to severe plaque psoriasis: A randomized controlled trial. JAMA 2003; 290:3073-3080.
20. Menter A, Gordon K, Carey W, et al. Efficacy and safety observed during 24 weeks of efalizumab therapy in patients with moderate to severe plaque psoriasis. Arch Dermatol 2005; 141:31-38.
21. Stern RS, Laird N. The carcinogenic risk of treatments for severe psoriasis. Photochemotherapy Follow-up Study. Cancer 1994; 73:2759-2764.
22. Raptiva® (efalizumab) package insert. South San Francisco, Genentech, Inc., June 2005.
23. Menter A, Kardatzke D, Rundle AC, et al. Incidence and prevention of rebound upon abrupt efalizumab discontinuation. Poster presented at: 10th Annual International Psoriasis Symposium, June, 10-13, 2004, Toronto, Ontario, Canada.
24. Papp KA, Mease PJ, Garovoy MR, et al. Efalizumab in patients with psoriatic arthritis: Results of a phase II, randomized, double-blind, placebo-controlled study. Poster presented at: 10th International Psoriasis Symposium, June 10-13, 2004, Toronto, Ontario, Canada.
25. Diepgen TL, Mahler V. The epidemiology of skin cancer. Br J Dermatol 2002; 146(suppl 61):1-6.
26. Harris RB, Griffith K, Moon TE. Trends in the incidence of nonmelanoma skin cancers in southeastern Arizona, 1985-1996. J Am Acad Dermatol 2001; 45:528-536.
27. Marcil I, Stern RS. Squamous-cell cancer of the skin in patients given PUVA and ciclosporine: nested cohort crossover study. Lancet 24756; 358:1042-1045.