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;CLEAR-studie (CLinical Experience Acquired with Raptiva® [mit Raptiva® gesammelte klinische erfahrung]) bei patienten mit mäßiger bis schwerwiegender psoriasis en plaques: Ergebnisse der therapieverlängerung in einer internationalen, placebokontrollierten Phase-III-studie

JDDG - Journal of the German Society of Dermatology

Volumn 4, Issue 11, 2006, Pages 947-956

  Sterry, Wolfram ^a   Stingl, Georg ^b   Langley, Richard G B ^c   Zacharie, Hugh ^d   Lahfa, Morad ^e   Giannetti, Alberto ^f   Ferrándiz, Carlos ^g   Sinclair, Rodney ^h   Saurat, Jean Hilaire ⁱ  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b Universitatsklinik fur Dermatologie   (Austria)

^c DALHOUSIE UNIVERSITY   (Canada)

^d Kjellerup Hospital   (Denmark)

^e SAINT LOUIS HOSPITAL   (France)

^f Azienda Ospedaliero Universitaria   (Italy)

^g HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^h ALFRED HOSPITAL   (Australia)

ⁱ GENEVA UNIVERSITY HOSPITALS   (Switzerland)

Author keywords

Anti CD11a; Efalizumab; Monoclonal antibody; Plaque psoriasis; Rebound; Refractory patients

Indexed keywords

EFALIZUMAB; PLACEBO;

ARTHRALGIA; ARTHROPATHY; ARTICLE; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DERMATITIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ERYTHRODERMA; FEVER; FLU LIKE SYNDROME; FOLLOW UP; HEADACHE; HUMAN; INFECTION; MAJOR CLINICAL STUDY; MYALGIA; NAUSEA; PHASE 3 CLINICAL TRIAL; PROTEINURIA; PSORIASIS; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RETREATMENT; RHINOPHARYNGITIS; THROMBOCYTOPENIA; TREATMENT OUTCOME;

EID: 33750540385     PISSN: 16100379     EISSN: 16100387     Source Type: Journal    
DOI: 10.1111/j.1610-0387.2006.06111.x     Document Type: Article

References (19)

1. Naldi L, Griffiths CEM. Traditional therapies in the management of moderate to severe chronic plaque psoriasis: an assessment of the benefits and risks. Br J Dermatol 2005; 152: 597-615.
2. Sterry W, Barker J, Boehncke W-H, Bos JD, Chimenti S, Christophers E, De La Brassinne M, Ferrandiz C, Griffiths C, Katsambas A, Kragballe K, Lynde C, Menter A, Ortonne JP, Papp K, Prinz J, Rzany B, Ronnevig J, Saurat JH, Stahle M, Stengel FM, Van De Kerkhof P, Voorhees J. Biological therapies in the systemic management of psoriasis: International Consensus Conference. Br J Dermatol 2004; 151 (Suppl. 69): 3-17.
3. Krueger JG. The immunologic basis for the treatment of psoriasis with new biologic agents. J Am Acad Dermatol 2002; 46: 1-23.
4. Jullien D, Prinz JC, Langley RGB, Caro I, Dummer W, Joshi A, Dedrick R, Natta P. T-cell modulation for the treatment of chronic plaque psoriasis with efalizumab (Raptiva™): mechanisms of action. Dermatology 2004; 208: 297-306.
5. Gordon KB, Papp KA, Hamilton TK, Walicke PA, Dummer W, Li N, Bresnahan BW, Menter A; Efalizumab Study Group. Efalizumab for patients with moderate to severe plaque psoriasis: a randomized controlled trial. JAMA 2003; 290: 3073-3080.
6. Lebwohl M, Tyring SK, Hamilton TK, Toth D, Glazer S, Tawfik NH, Walicke P, Dummer W, Wang X, Garovoy MR, Pariser D; Efalizumab Study Group. A novel targeted T-cell modulator, efalizumab, for plaque psoriasis. N Engl J Med 2003; 349: 2004-2013.
7. Leonardi CL, Papp KA, Gordon KB, Menter A, Feldman SR, Caro I, Walicke PA, Compton PG, Gottlieb AB, 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.
8. Dubertret L, Sterry W, Bos JD, Chimenti S, Shumack S, Larsen CG, Shear NH, Papp KA on behalf of the CLEAR Multinational Study Group. Efalizumab for patients with moderate to severe plaque psoriasis: the international, randomised, controlled phase III Clinical Experience Acquired with Raptiva® (CLEAR) trial. Br J Dermatol 2006 (in press).
9. United States Food and Drug Administration. The FDA Safety Information and Adverse Event Reporting Program. MedDRA: Medical Dictionary for Regulatory Activities. Available at: http://www.fda.gov/medwatch/report/meddra.htm. Accessed 16 June 2004.
10. Carey WD, Rundle AC, Kwon P, Leonardi CL. Taper regimens in the management of patients discontinuing efalizumab therapy. Poster presented at the 11th International Psoriasis Symposium, 14-19 June 2004, Toronto, Canada.
11. Bauer RJ, Dedrick RL, White ML, Murray MJ, Garovoy MR. Population pharmacokinetics and pharmacodynamics of the anti-CD11a antibody hu1124 in human subjects with psoriasis. J Pharmacokinet Biopharm 1999; 27: 397-420.
12. Heydendael VM, Spuls PI, Opmeer BC, de Borgie CA, Reitsma JB, Goldschmidt WF, Bossuyt PM, Bos JD, de Rie MA. Methotrexate versus cyclosporine in moderate-to-severe chronic plaque psoriasis. N Engl J Med 2003; 349: 658-665.
13. Spuls PI, Witkamp L, Bossuyt PM, Bos JD. A systematic review of five systemic treatments for severe psoriasis. Br J Dermatol 1997; 137: 943-949.
14. Gordon KB, Feldman SR, Koo JYM, Menter A, Rolstad T, Krueger G. Definitions and measures of effect duration for psoriasis treatment. Arch Dermatol 2005; 141: 82-84.
15. European Medicines Agency Committee for Medicinal Products for Human Use (CHMP). Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis (CHMP/EWP/2454/02 corr.) London: European Medicines Agency, 2004: 9.
16. Carey W, Glazer S, Gottlieb AB, Lebwohl M, Leonardi C, Menter A, Papp K, Rundle AC, Toth D. Relapse, rebound, and psoriasis adverse events: an advisory group report. J Am Acad Dermatol. 2006; 54 (4 Suppl. 1): S171-S181.
17. Gordon KB, Trying S, Hamilton T, Lebwohl M. Examining duration of response and rebound during treatment with efalizumab. Poster presented at the American Association of Dermatology; 21-26 March 2003, San Francisco, CA, USA.
18. Menter A, Kardatzke D, Rundle AC, Kwon P, Garovoy MR, Leonardi CL. Incidence and prevention of rebound upon efalizumab discontinuation. Poster presented at the 11th International Psoriasis Symposium, 14-19 June 2004, Toronto, Canada.
19. Carey W, Toth D, Bissonnette R, Langley R. No evidence for increased risk of infection during efalizumab treatment: a review of the clinical data. J Eur Acad Dermatol Venereol 2004; 18 (Suppl. 2): 193.