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

Archives of Dermatological Research

Volumn 298, Issue 7, 2007, Pages 329-338

  Pincelli, Carlo ^a   Henninger, Eric ^b   Casset Semanaz, Florence ^b  

^a UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^b Serono International SA   (Switzerland)

Author keywords

Arthritis; Arthropathy; Efalizumab; Psoriasis; Psoriatic arthritis

Indexed keywords

EFALIZUMAB; FLUOCINOLONE; PETROLATUM; PLACEBO;

ADULT; ARTHROPATHY; ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; DATA ANALYSIS; DISEASE ASSOCIATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; INCIDENCE; LONG TERM CARE; MALE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PSORIASIS VULGARIS; RANDOMIZED CONTROLLED TRIAL; STATISTICS; TREATMENT DURATION;

EID: 33751168455     PISSN: 03403696     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00403-006-0694-9     Document Type: Article

References (27)

1. Dustin ML, Springer TA (1988) Lymphocyte function-associated antigen-1 (LFA-1) interaction with intercellular adhesion molecule-1 (ICAM-1) is one of at least three mechanisms for lymphocyte adhesion to cultured endothelial cells. J Cell Biol 107:321-331
2. EMEA (2000) EMEA public statement on infliximab (Remicade) - reports of tuberculosis infections. Accessed 17 January 2006 http://www.emea.eu.int/pdfs/ human/press/pus/444500en.pdf
3. FDA (1995) COSTART: coding symbols for thesaurus of adverse reaction terms, 5th edn. pp 1-540
4. Gordon KB, Papp KA, Hamilton TK, Walicke PA, Dummer W, Li N, Bresnahan BW, Menter A (2003) Efalizumab for patients with moderate to severe plaque psoriasis: a randomized controlled trial. JAMA 290:3073-3080
5. Gottlieb AB, Gordon KB, Hamilton TK, Caro I, Kwon P, Compton P (2005) Maintenance of efficacy and safety with continuous efalizumab therapy in patients with moderate to severe chronic plaque psoriasis: Wnal phase IIIb study results. Poster presented at the 63rd Annual Meeting of the American Academy of Dematology (AAD)
6. Gottlieb AB, Gordon KB, Lebwohl MG, Caro I, Walicke PA, Li N, Leonardi CL (2004) Extended efalizumab therapy sustains efficacy without increasing toxicity in patients with moderate to severe chronic plaque psoriasis. J Drugs Dermatol 3:614-624
7. Gottlieb AB, Hamilton T, Caro I, Kwon P, Compton PG, Leonardi CL (2006) Long-term continuous efalizumab therapy in patients with moderate to severe chronic plaque psoriasis: updated results from an ongoing trial. J Am Acad Dermatol 54:S154-S163
8. Hamilton TK (2005) Clinical considerations of efalizumab therapy in patients with psoriasis. Semin Cutan Med Surg 24:19-27
9. Husted JA, Gladman DD, Farewell VT, Cook RJ (2001) Health-related quality of life of patients with psoriatic arthritis: a comparison with patients with rheumatoid arthritis. Arthritis Rheum 45:151-158
10. Krueger J, Gottlieb A, Miller B, Dedrick R, Garovoy M, Walicke P (2000) Anti-CD11a treatment for psoriasis concurrently increases circulating T-cells and decreases plaque T-cells, consistent with inhibition of cutaneous T-cell trafficking. J Invest Dermatol 115:333
11. Kuypers TW, Roos D (1989) Leukocyte membrane adhesion proteins LFA-1, CR3 and p150,95: a review of functional and regulatory aspects. Res Immunol 140:461-486
12. Lebwohl M et al (2003) A novel targeted T-cell modulator, efalizumab, for plaque psoriasis. N Engl J Med 349:2004-2013
13. Leonardi CL, Papp KA, Gordon KB, Menter A, Feldman SR, Caro I, Walicke PA, Compton PG, Gottlieb AB (2005) Extended efalizumab therapy improves chronic plaque psoriasis: results from a randomized phase III trial. J Am Acad Dermatol 52:425-433
14. Menter A, Gordon K, Carey W, Hamilton T, Glazer S, Caro I, Li N, Gulliver W (2005) Efficacy and safety observed during 24 weeks of efalizumab therapy in patients with moderate to severe plaque psoriasis. Arch Dermatol 141:31-38
15. Menter A, Hamilton TK, Caro I, Kwon P, Compton P, Papp KA (2005) Safety and tolerability of efalizumab therapy for patients with moderate to severe chronic plaque psoriasis: results of an open-label phase IIIb multicenter trial. Poster presented at the 63rd Annual Meeting of the American Academy of Dematology (AAD)
16. Papp K, Miller B, Gordon KB, Caro I, Kwon P, Comptom PG, Leonardi CL (2006) Efalizumab retreatment in patients with moderate to severe chronic plaque psoriasis. J Am Acad Dermatol Suppl (in press)
17. Papp KA, Bressnick R, Fretzin S, Goffe B, Kempers S, Gordon KB (2005) The safety of efalizumab in adults with chronic moderate to severe plaque psoriasis: a Phase IIIb randomized, controlled trial. Int J Dermatol (in press)
18. Reich K, Nestle FO, Papp K, Ortonne JP, Evans R, Guzzo C, Li S, Dooley LT, Griffiths CE (2005) Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet 366:1367-1374
19. Scheinfeld N (2004) Off-label uses and side effects of infliximab. J Drugs Dermatol 3:273-284
20. Scheinfeld N (2005) Alefacept: a safety profile. Expert Opin Drug Saf 4:975-985
21. Springer TA, Dustin ML, Kishimoto TK, Marlin SD (1987) The lymphocyte function-associated LFA-1, CD2, and LFA-3 molecules: cell adhesion receptors of the immune system. Annu Rev Immunol 5:223-252
22. Sterry W, Dubertret L, Papp K, Chimenti S, Larsen CG (2004) Efalizumab for patients with moderate to severe chronic plaque psoriasis: results of the international, randomised, controlled phase III clinical experience acquired with Raptiva (CLEAR) trial. poster presented at the 34th Annual European Society for Dermatological Research (ESDR) Meeting, ABST no. 386
23. Tristani-Firouzi P, Krueger GG (1998) Efficacy and safety of treatment modalities for psoriasis. Cutis 61:11-21
24. Vigliani G (2002) Biogen safety presentation on Alefacept to the FDA. Accessed 17 January 2006 http://www.fda.gov/ohrms/dockets/ac/02/slides/ 3865S1_04_Biogen-Safety/sld007.htm
25. Werther WA et al (1996) 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 157:4986-4995
26. Yamauchi PS, Gindi V, Lowe NJ (2004) The treatment of psoriasis and psoriatic arthritis with etanercept: practical considerations on monotherapy, combination therapy, and safety. Dermatol Clin 22:449-459, ix
27. Zachariae H, Zachariae R, Blomqvist K, Davidsson S, Molin L, Mork C, Sigurgeirsson B (2002) Quality of life and prevalence of arthritis reported by 5,795 members of the Nordic psoriasis associations. Data from the Nordic Quality of Life Study. Acta Derm Venereol 82:108-113