Abatacept in the treatment of patients with psoriatic arthritis: Results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial

Arthritis and Rheumatism

Volumn 63, Issue 4, 2011, Pages 939-948

  Mease, Philip ^a,k   Genovese, Mark C ^b   Gladstein, Geoffrey ^c   Kivitz, Alan J ^d   Ritchlin, Christopher ^e   Tak, Paul P ^f   Wollenhaupt, Jürgen ^g   Bahary, Orna ^h   Becker, Jean Claude ^h   Kelly, Sheila ^h   Sigal, Leonard ^h   Teng, Julie ⁱ   Gladman, Dafna ^j  

^a UNIVERSITY OF WASHINGTON   (United States)

^b STANFORD UNIVERSITY   (United States)

^c New England Research Associates   (United States)

^d Altoona Center for Clinical Research   (United States)

^e UNIVERSITY OF ROCHESTER   (United States)

^f ACADEMIC MEDICAL CENTER   (Netherlands)

^g Schoen Klinik   (Germany)

^h ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

ⁱ BRISTOL MYERS SQUIBB   (United States)

^j UNIVERSITY OF TORONTO   (Canada)

^k Seattle Rhumatology Associates   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ABATACEPT; C REACTIVE PROTEIN; PLACEBO; PREDNISONE;

ADULT; ARTHRALGIA; ARTICLE; BASAL CELL CARCINOMA; CHOLECYSTITIS; CONTROLLED STUDY; DISEASE DURATION; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; GASTROENTERITIS; HEALTH ASSESSMENT QUESTIONNAIRE; HUMAN; INJECTION SITE REACTION; JOINT INJURY; JOINT SWELLING; MAJOR CLINICAL STUDY; MALE; MEDICAL SOCIETY; MULTICENTER STUDY; NUCLEAR MAGNETIC RESONANCE IMAGING; OSTEITIS; OSTEOMYELITIS; PERSONALITY DISORDER; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PSORIASIS AREA AND SEVERITY INDEX; PSORIATIC ARTHRITIS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SHORT FORM 36; SYNOVITIS; TREATMENT DURATION; TREATMENT RESPONSE; VISUAL ANALOG SCALE;

ADULT; ANTIRHEUMATIC AGENTS; ARTHRITIS, PSORIATIC; CD4-POSITIVE T-LYMPHOCYTES; CD8-POSITIVE T-LYMPHOCYTES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMMUNOCONJUGATES; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 79953701653     PISSN: 00043591     EISSN: 15290131     Source Type: Journal    
DOI: 10.1002/art.30176     Document Type: Article

References (46)

1. Gladman DD, Shuckett R, Russell ML, Thorne JC, Schachter RK. Psoriatic arthritis (PSA)-an analysis of 220 patients. Q J Med 1987;62:127-41. (Pubitemid 17042878)
2. Gladman DD, Stafford-Brady F, Chang CH, Lewandowski K, Russell ML. Longitudinal study of clinical and radiological progression in psoriatic arthritis. J Rheumatol 1990;17:809-12. (Pubitemid 20213507)
3. Shbeeb M, Uramoto KM, Gibson LE, O'Fallon WM, Gabriel SE. The epidemiology of psoriatic arthritis in Olmsted County, Minnesota, USA, 1982-1991. J Rheumatol 2000;27:1247-50. (Pubitemid 30262512)
4. Gelfand JM, Gladman DD, Mease PJ, Smith N, Margolis DJ, Nijsten T, et al. Epidemiology of psoriatic arthritis in the population of the United States. J Am Acad Dermatol 2005;53:573.
5. Radtke MA, Reich K, Blome C, Rustenbach S, Augustin M. Prevalence and clinical features of psoriatic arthritis and joint complaints in 2009 patients with psoriasis: results of a German national survey. J Eur Acad Dermatol Venereol 2009;23:683-91.
6. Reich K, Kruger K, Mossner R, Augustin M. Epidemiology and clinical pattern of psoriatic arthritis in Germany: a prospective interdisciplinary epidemiological study of 1511 patients with plaque-type psoriasis. Br J Dermatol 2009;160:1040-7.
7. Ritchlin CT, Kavanaugh A, Gladman DD, Mease PJ, Helliwell P, Boehncke WH, et al. Treatment recommendations for psoriatic arthritis. Ann Rheum Dis 2009;68:1387-94.
8. Mease PJ, Kivitz AJ, Burch FX, Siegel EL, Cohen SB, Ory P, et al. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rheum 2004;50:2264-72. (Pubitemid 38924405)
9. Antoni C, Krueger GG, de Vlam K, Birbara C, Beutler A, Guzzo C, et al, for the IMPACT 2 Investigators. Infliximab improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial. Ann Rheum Dis 2005;64:1150-7. (Pubitemid 41113349)
10. Antoni CE, Kavanaugh A, Kirkham B, Tutuncu Z, Burmester GR, Schneider U, et al. Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis: results from the Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT). Arthritis Rheum 2005;52:1227-36. (Pubitemid 40530131)
11. Antoni CE, Kavanaugh A, van der Heijde D, Beutler A, Keenan G, Zhou B, et al. Two-year efficacy and safety of infliximab treatment in patients with active psoriatic arthritis: findings of the Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT). J Rheumatol 2008;35:869-76. (Pubitemid 351747130)
12. Mease PJ, Gladman DD, Ritchlin CT, Ruderman EM, Steinfeld SD, Choy EH, et al, for the Adalimumab Effectiveness in Psoriatic Arthritis Trial Study Group. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005;52:3279-89. (Pubitemid 41447111)
13. Gladman DD, Mease PJ, Ritchlin CT, Choy EH, Sharp JT, Ory P, et al. Adalimumab for long-term treatment of psoriatic arthritis: forty-eight-week data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial. Arthritis Rheum 2007;56:476-88.
14. Genovese MC, Mease PJ, Thomson GT, Kivitz AJ, Perdok RJ, Weinberg MA, et al. Safety and efficacy of adalimumab in treatment of patients with psoriatic arthritis who had failed disease modifying antirheumatic drug therapy. J Rheumatol 2007;34: 1040-50. (Pubitemid 46774851)
15. Mease PJ, Ory P, Sharp JT, Ritchlin CT, Van den Bosch F, Wellborne F, et al. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis 2009;68: 702-9.
16. Kavanaugh A, McInnes I, Mease P, Krueger GG, Gladman D, Gomez-Reino J, et al. Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: twenty-four-week efficacy and safety results of a randomized, placebo-controlled study. Arthritis Rheum 2009;60:976-86.
17. Choy E. T cells in psoriatic arthritis. Curr Rheumatol Rep 2007;9:437-41. (Pubitemid 350305199)
18. Van Kuijk AW, Reinders-Blankert P, Smeets TJ, Dijkmans BA, Tak PP. Detailed analysis of the cell infiltrate and the expression of mediators of synovial inflammation and joint destruction in the synovium of patients with psoriatic arthritis: implications for treatment. Ann Rheum Dis 2006;65:1551-7. (Pubitemid 44799664)
19. Kraan MC, van Kuijk AW, Dinant HJ, Goedkoop AY, Smeets TJ, de Rie MA, et al. Alefacept treatment in psoriatic arthritis: reduction of the effector T cell population in peripheral blood and synovial tissue is associated with improvement of clinical signs of arthritis. Arthritis Rheum 2002;46:2776-84. (Pubitemid 36118943)
20. Mease PJ, Gladman DD, Keystone EC, on behalf of the Alefacept in Psoriatic Arthritis Study Group. Alefacept in combination with methotrexate for the treatment of psoriatic arthritis: results of a randomized, double-blind, placebo-controlled study. Arthritis Rheum 2006;54:1638-45.
21. Mease PJ, Reich K. Alefacept with methotrexate for treatment of psoriatic arthritis: open-label extension of a randomized, doubleblind, placebo-controlled study. J Am Acad Dermatol 2009;60: 402-11.
22. Van Kuijk AW, Gerlag DM, Vos K, Wolbink G, de Groot M, de Rie MA, et al. A prospective, randomised, placebo-controlled study to identify biomarkers associated with active treatment in psoriatic arthritis: effects of adalimumab treatment on synovial tissue. Ann Rheum Dis 2009;68:1303-9.
23. Linsley PS, Nadler SG. The clinical utility of inhibiting CD28- mediated costimulation. Immunol Rev 2009;229:307-21.
24. Weisman MH, Durez P, Hallegua D, Aranda R, Becker JC, Nuamah I, et al. Reduction of inflammatory biomarker response by abatacept in treatment of rheumatoid arthritis. J Rheumatol 2006;33:2162-6. (Pubitemid 44749773)
25. Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor α inhibition. N Engl J Med 2005;353: 1114-23. (Pubitemid 41317434)
26. Genant HK, Peterfy CG, Westhovens R, Becker JC, Aranda R, Vratsanos G, et al. Abatacept inhibits progression of structural damage in rheumatoid arthritis: results from the long-term extension of the AIM trial. Ann Rheum Dis 2008;67:1084-9.
27. Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, et al. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med 2006;20;144:865-76. (Pubitemid 46768126)
28. Genovese MC, Schiff M, Luggen M, Becker JC, Aranda R, Teng J, et al. Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy. Ann Rheum Dis 2008;67:547-54. (Pubitemid 351498439)
29. Kremer JM, Dougados M, Emery P, Durez P, Sibilia J, Shergy W, et al. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase IIb, double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005;52:2263-71. (Pubitemid 41117408)
30. Ruperto N, Lovell DJ, Quartier P, Paz E, Rubio-Perez N, Silva CA, et al. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial. Lancet 2008;372:383-91.
31. Abrams JR, Lebwohl MG, Guzzo CA, Jegasothy BV, Goldfarb MT, Goffe BS, et al. CTLA4Ig-mediated blockade of T cell costimulation in patients with psoriasis vulgaris. J Clin Invest 1999;103:1243-52. (Pubitemid 29218294)
32. Abrams JR, Kelley SL, Hayes E, Kikuchi T, Brown MJ, Kang S, et al. Blockade of T lymphocyte costimulation with cytotoxic T lymphocyte-associated antigen 4-immunoglobulin (CTLA4Ig) reverses the cellular pathology of psoriatic plaques, including the activation of keratinocytes, dendritic cells, and endothelial cells. J Exp Med 2000;192:681-94.
33. Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease P, Mielants H, and the CASPAR Study Group. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum 2006;54:2665-73. (Pubitemid 44205029)
34. Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727-35.
35. Fries JF, Spitz PW, Young DY. The dimensions of health outcomes: the Health Assessment Questionnaire, disability and pain scales. J Rheumatol 1982;9:789-93.
36. Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.
37. Ellis CN, Krueger GG. Treatment of chronic plaque psoriasis by selective targeting of memory effector T lymphocytes. N Engl J Med 2001;345:248-55. (Pubitemid 32695064)
38. Mease P, Ganguly R, Wanke L, Singh A. How much improvement in functional status is considered important by patients with active psoriatic arthritis: applying the outcome measures in rheumatoid arthritis clinical trials (OMERACT) group guidelines. Ann Rheum Dis 2004;63 Suppl 1:i39-45.
39. Fredriksson T, Pettersson U. Severe psoriasisoral therapy with a new retinoid. Dermatologica 1978;157:238-44. (Pubitemid 8387357)
40. McQueen F, Lassere M, Bird P, Haavardsholm EA, Peterfy C, Conaghan PG, et al. Developing a magnetic resonance imaging scoring system for peripheral psoriatic arthritis. J Rheumatol 2007;34:859-61. (Pubitemid 46641399)
41. Ostergaard M, Peterfy C, Conaghan P, McQueen F, Bird P, Ejbjerg B, et al. OMERACT rheumatoid arthritis magnetic resonance imaging studies: core set of MRI acquisitions, joint pathology definitions, and the OMERACT RA-MRI scoring system. J Rheumatol 2003;30:1385-6. (Pubitemid 36666373)
42. Samsa G, Edelman D, Rothman ML, Williams GR, Lipscomb J, Matchar D. Determining clinically important differences in health status measures: a general approach with illustration to the Health Utilities Index Mark II. Pharmacoeconomics 1999;15:141-55. (Pubitemid 29093257)
43. Mease PJ, van der Heijde D. Joint damage in psoriatic arthritis: how is it assessed and can it be prevented? Int J Adv Rheumatol 2006;4:38-48.
44. Mease PJ, Kivitz AJ, Burch FX, Siegel EL, Cohen SB, Ory P, et al. Continued inhibition of radiographic progression in patients with psoriatic arthritis following 2 years of treatment with etanercept. J Rheumatol 2006;33:712-21.
45. Anandarajah AP, Ory P, Salonen D, Feng C, Wong RL, Ritchlin CT. Effect of adalimumab on joint disease features of patients with psoriatic arthritis detected by magnetic resonance imaging. Ann Rheum Dis 2010;69:206-9.
46. Strand V, Sharp JT. Radiographic data from recent randomized controlled trials in rheumatoid arthritis: what have we learned? [review]. Arthritis Rheum 2003;48:21-34. (Pubitemid 36091644)