Clinical effectiveness and safety experience with efalizumab in the treatment of patients with moderate-to-severe plaque psoriasis in Taiwan: Results of an open-label, single-arm pilot study

Journal of the European Academy of Dermatology and Venereology

Volumn 22, Issue 3, 2008, Pages 345-352

  Tsai, T F ^a   Liu, M T ^b   Liao, Y H ^a   Licu, D ^c  

^a NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^b TAIPEI VETERANS GENERAL HOSPITAL   (Taiwan)

^c MERCK SERONO S A   (Switzerland)

Author keywords

Clinical trial; Efalizumab; Monoclonal antibody; Pilot; Psoriasis

Indexed keywords

ANTINUCLEAR ANTIBODY; CALCIPOTRIOL; CORTICOSTEROID; CYCLOSPORIN; EFALIZUMAB; EMOLLIENT AGENT; ETANERCEPT; ETRETIN; HYDROCORTISONE; METHOTREXATE; SALICYLIC ACID; TAR;

ADULT; AGED; ANEMIA; ANTIBODY DETECTION; ANTIBODY PRODUCTION; ARTHRALGIA; ARTHRITIS; ARTHROPATHY; ARTICLE; BACKACHE; BASOPHIL; CLINICAL EFFECTIVENESS; COLD SENSITIVITY; CONTROLLED STUDY; DERMATITIS; DISEASE SEVERITY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; FEMALE; HUMAN; INSOMNIA; LARYNX PAIN; LEUKOCYTE; LEUKOCYTOSIS; LOADING DRUG DOSE; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALAISE; MALE; MYALGIA; NEUTROPHIL COUNT; OPEN STUDY; PAIN; PERIPHERAL EDEMA; PILOT STUDY; PRIORITY JOURNAL; PRURITUS; PSORIASIS; REBOUND; SIDE EFFECT; SKIN PAIN; TAIWAN; UPPER RESPIRATORY TRACT INFECTION;

ADULT; ANTIBODIES, MONOCLONAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG TOLERANCE; DRUG TOXICITY; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; PILOT PROJECTS; PSORIASIS; SEVERITY OF ILLNESS INDEX; TAIWAN; TREATMENT OUTCOME;

EID: 39049129176     PISSN: 09269959     EISSN: 14683083     Source Type: Journal    
DOI: 10.1111/j.1468-3083.2007.02430.x     Document Type: Article

References (31)

1. Langley RGB, Krueger GG, Griffiths CEM. Psoriasis: Epidemiology, clinical features, and quality of life. Ann Rheum Dis 2005; 64 (Suppl. 2): Ii18-i23.
2. Bowcock AM, Krueger JG. Getting under the skin: The immunogenetics of psoriasis. Nat Rev Immunol 2005; 5: 699-711.
3. Jullien D, Prinz JC, Langley RG et al. T-cell modulation for the treatment of chronic plaque psoriasis with efalizumab (Raptiva): mechanisms of action. Dermatology 2004; 208: 297-306.
4. Lebwohl M, Tyring SK, Hamilton TK et al.; Efalizumab Study Group. A novel targeted T-cell modulator, efalizumab, for plaque psoriasis. N Engl J Med 2003; 349: 2004-2013.
5. Pariser DM, Gordon KB, Papp KA et al. Clinical efficacy of efalizumab in patients with chronic plaque psoriasis: Results from three randomized placebo-controlled phase III trials: Part I. J Cutan Med Surg 2005; 9: 303-312.
6. Dubertret L, Sterry W, Bos JD et al. Clinical experience acquired with the efalizumab (Raptiva) (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: Results from a phase III international randomized, placebo-controlled trial. Br J Dermatol 2006; 155: 170-181.
7. 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.
8. Gottlieb AB, Gordon KB, Lebwohl MG et al.; Efalizumab Study Group. Extended efalizumab therapy sustains efficacy without increasing toxicity in patients with moderate to severe chronic plaque psoriasis. J Drugs Dermatol 2004; 3: 614-624.
9. Leonardi CL, Papp KA, Gordon KB et al.; Efalizumab Study Group. Extended efalizumab therapy improves chronic plaque psoriasis: Results from a randomized phase III trial. J Am Acad Dermatol 2005; 52: 425-433.
10. 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.
11. Papp K, Miller B, Gordon KB et al.; Efalizumab Study Group. Efalizumab retreatment in patients with moderate to severe chronic plaque psoriasis. J Am Acad Dermatol 2006; 54 (4 Suppl. 1): S164-S170.
12. Papp KA, Bressinck R, Fretzin S et al.; Efalizumab Study Group. Safety of efalizumab in adults with chronic moderate to severe plaque psoriasis: A phase IIIb, randomized, controlled trial. Int J Dermatol 2006; 45: 605-614.
13. Sterry W, Stingl G, Langley RG et al.; CLEAR Multinational Study Group. Clinical Experience Acquired with Raptiva (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: Results from extended treatment in an international, phase III, placebo-controlled trial. J Dtsch Dermatol Ges 2006; 4: 947-956.
14. Yip SY. The prevalence of psoriasis in the Mongoloid race. J Am Acad Dermatol 1984; 10: 965-968.
15. Chua-Ty G, Goh CL, Koh SL. Pattern of skin diseases at the National Skin Centre (Singapore) from 1989-1990. Int J Dermatol 1989; 31: 555-559.
16. Tsai TF. Current status and prospect for psoriasis treatment in Taiwan. Dermatol Sinica 2005; 23: 69-80.
17. Tsai TF, Hu CY, Tsai WL et al. HLA-Cw6 specificity and polymorphic residues are associated with susceptibility among Chinese psoriatics in Taiwan. Arch Dermatol Res 2002; 294: 214-220.
18. Papp KA, Henninger E. Safe psoriasis control: A new outcome measure for the composite assessment of the efficacy and safety of psoriasis treatment. J Cutan Med Surg 2005; 9: 276-283.
19. Jacobson CC, Kimball AB. Rethinking the Psoriasis Area and Severity Index: The impact of area should be increased. Br J Dermatol 2004; 151: 381-387.
20. Ashcroft D. Li W, Po A, Williams H, Griffiths C. Clinical measures of disease severity and outcome in psoriasis: A critical appraisal of their quality. Br J Dermatol 1999; 141: 185-191.
21. Gottlieb AB, Hamilton T, Caro I et al.; 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 (4 Suppl. 1): S154-S163.
22. Ortonne JP, Shear N, Shumack S, Henninger E; CLEAR Multinational Study Group. Impact of efalizumab on patient-reported outcomes in high-need psoriasis patients: Results of the international, randomized, placebo-controlled Phase III Clinical Experience Acquired with Raptiva (CLEAR) trial [NCT00256139]. BMC Dermatol 2005; 5: 13.
23. Menter A, Kosinski M, Bresnahan BW, Papp KA, Ware JE Jr. Impact of efalizumab on psoriasis-specific patient-reported outcomes. Results from three randomized, placebo-controlled clinical trials of moderate to severe plaque psoriasis. J Drugs Dermatol 2004; 3: 27-38.
24. Hamilton TK. Clinical considerations of efalizumab therapy in patients with psoriasis. Semin Cutan Med Surg 2005; 24: 19-27.
25. Mortensen DL, Walicke PA, Wang X et al. Pharmacokinetics and pharmacodynamics of multiple weekly subcutaneous efalizumab doses in patients with plaque psoriasis. J Clin Pharmacol 2005; 45: 286-298.
26. Dedrick RL, Bauer R, Bohmann D, Walicke P, Garovoy MR. Pharmacokinetics and pharmacodynamics of subcutaneously administered efalizumab (anti-CD11a) in psoriasis subjects. Poster presented at: 59th Annual Meeting of the American Academy of Dermatology. Abstract and poster, Washington, DC, 2001: 505.
27. Joshi A, Bauer R, Kuebler P et al. An overview of the pharmacokinetics and pharmacodynamics of efalizumab: A monoclonal antibody approved for use in psoriasis. J Clin Pharmacol 2006; 46: 10-20.
28. Papp KA, Camisa C, Stone SP et al. Safety of efalizumab in patients with moderate to severe chronic plaque psoriasis: Review of clinical data. Part II. J Cutan Medical Surg 2005; 9: 313-323.
29. Scheinfeld N. Efalizumab: A review of events reported during clinical trials and side effects. Expert Opin Drug Saf 2006; 5: 197-209.
30. Pincelli C, Henninger E, Casset-Semanaz F. The incidence of arthropathy adverse events in efalizumab-treated patients is low and similar to placebo and does not increase with long-term treatment: Pooled analysis of data from Phase III clinical trials of efalizumab. Arch Dermatol Res 2006; 298: 329-338.
31. Carey W, Glazer S, Gottlieb AB et al. Relapse, rebound, and psoriasis adverse events: An advisory group report. J Am Acad Dermatol 2006; 54 (4 Suppl. 1): S171-S181.