Effect of certolizumab pegol on multiple facets of psoriatic arthritis as reported by patients: 24-week patient-reported outcome results of a phase III, multicenter study

Arthritis Care and Research

Volumn 66, Issue 7, 2014, Pages 1085-1092

  Gladman, D ^a   Fleischmann, R ^b   Coteur, G ^c   Woltering, F ^c   Mease, P J ^d  

^a UNIVERSITY HEALTH NETWORK   (Canada)

^b METROPLEX CLINICAL RESEARCH CENTER   (United States)

^c UCB PHARMA   (Belgium)

^d UNIVERSITY OF WASHINGTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CERTOLIZUMAB PEGOL; PLACEBO; TUMOR NECROSIS FACTOR INHIBITOR;

ADULT; ARTICLE; DERMATOLOGY LIFE QUALITY INDEX; DOSAGE SCHEDULE COMPARISON; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFECT; FATIGUE; FATIGUE ASSESSMENT SCALE; FEMALE; HEALTH ASSESSMENT QUESTIONNAIRE; HEALTH STATUS; HUMAN; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PSORIATIC ARTHRITIS; PSORIATIC ARTHRITIS QUALITY OF LIFE; QUALITY OF LIFE; SHORT FORM 36; TREATMENT DURATION; TREATMENT OUTCOME; VISUAL ANALOG SCALE;

ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; ARTHRITIS, PSORIATIC; COST OF ILLNESS; FEMALE; HUMANS; IMMUNOGLOBULIN FAB FRAGMENTS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; QUALITY OF LIFE; SELF REPORT; TREATMENT OUTCOME;

EID: 84903445140     PISSN: 2151464X     EISSN: 21514658     Source Type: Journal    
DOI: 10.1002/acr.22256     Document Type: Article

References (25)

1. Haroon M, Kirby B, FitzGerald O,. High prevalence of psoriatic arthritis in patients with severe psoriasis with suboptimal performance of screening questionnaires. Ann Rheum Dis 2013; 72: 736-40.
2. Mease PJ, Gladman DD, Papp KA, Khraishi MM, Thaci D, Behrens F, et al. Prevalence of rheumatologist-diagnosed psoriatic arthritis in psoriasis patients in European/North American dermatology clinics. J Am Acad Dermatol 2013; 69: 729-35.
3. Kane D, Stafford L, Bresnihan B, FitzGerald O,. A prospective, clinical and radiological study of early psoriatic arthritis: an early synovitis clinic experience. Rheumatology (Oxford) 2003; 42: 1460-8.
4. Alonso JC, Perez AR, Castrillo JM, Garcia JB, Noriega JL, Larrea CL,. Psoriatic arthritis (PA): a clinical, immunological and radiological study of 180 patients. Rheumatology (Oxford) 1991; 30: 245-50.
5. McHugh NJ, Balachrishnan C, Jones SM,. Progression of peripheral joint disease in psoriatic arthritis: a 5-yr prospective study. Rheumatology (Oxford) 2003; 42: 778-83.
6. Rosen CF, Mussani F, Chandran V, Eder L, Thavaneswaran A, Gladman DD,. Patients with psoriatic arthritis have worse quality of life than those with psoriasis alone. Rheumatology (Oxford) 2012; 51: 571-6.
7. Gladman DD, Antoni C, Mease P, Clegg DO, Nash P,. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis 2005; 64 Suppl: ii14-7.
8. Husted JA, Gladman DD, Farewell VT, Long JA, Cook RJ,. Validating the SF-36 health survey questionnaire in patients with psoriatic arthritis. J Rheumatol 1997; 24: 511-7.
9. Husted JA, Gladman DD, Farewell VT, Cook RJ,. Health-related quality of life of patients with psoriatic arthritis: a comparison with patients with rheumatoid arthritis. Arthritis Rheum 2001; 45: 151-8.
10. Palominos PE, Gaujoux-Viala C, Fautrel B, Dougados M, Gossec L,. Clinical outcomes in psoriatic arthritis: a systematic literature review. Arthritis Care Res (Hoboken) 2012; 64: 397-406.
11. Gladman DD, Mease PJ, Strand V, Healy P, Helliwell PS, Fitzgerald O, et al. Consensus on a core set of domains for psoriatic arthritis. J Rheumatol 2007; 34: 1167-70.
12. Mease PJ,. Measures of psoriatic arthritis: tender and swollen joint assessment, Psoriasis Area and Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), modified Nail Psoriasis Severity Index (mNAPSI), Mander/Newcastle Enthesitis Index (MEI), Leeds Enthesitis Index (LEI), Spondyloarthritis Research Consortium of Canada (SPARCC), Maastricht Ankylosing Spondylitis Enthesis Score (MASES), Leeds Dactylitis Index (LDI), patient global for psoriatic arthritis, Dermatology Life Quality Index (DLQI), Psoriatic Arthritis Quality of Life (PsAQOL), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Psoriatic Arthritis Response Criteria (PsARC), Psoriatic Arthritis Joint Activity Index (PsAJAI), Disease Activity in Psoriatic Arthritis (DAPSA), and Composite Psoriatic Disease Activity Index (CPDAI). Arthritis Care Res (Hoboken) 2011; 63 Suppl: S64-85.
13. Keystone E, van der Heijde D, Mason D Jr, Landewe R, van Vollenhoven R, Combe B, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum 2008; 58: 3319-29.
14. Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, et al. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol 2012; 167: 180-90.
15. Mease PJ, Fleischmann R, Deodhar AA, Wollenhaupt J, Khraishi M, Kielar D, et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24 week results of a phase 3 double blind randomized placebo-controlled study (RAPID-PsA). Ann Rheum Dis 2014; 73: 48-55.
16. 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.
17. 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.
18. Van der Heijde D, Fleischmann R, Wollenhaupt J, Deodhar A, Kielar D, Woltering F, et al. Effect of different imputation approaches on the evaluation of radiographic progression in patients with psoriatic arthritis: the RAPID-PsA 24-week phase 3 double-blind randomized placebo-controlled study of certolizumab pegol. Ann Rheum Dis 2014; 73: 233-7.
19. Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008; 9: 105-21.
20. Strand V, Scott DL, Emery P, Kalden JR, Smolen JS, Cannon GW, et al. Physical function and health related quality of life: analysis of 2-year data from randomized, controlled studies of leflunomide, sulfasalazine, or methotrexate in patients with active rheumatoid arthritis. J Rheumatol 2005; 32: 590-601.
21. Mease PJ, Ganguly R, Wanke L, Yu E, 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 [abstract]. Ann Rheum Dis 2004; 63 Suppl: SAT0015.
22. Mease PJ, Woolley JM, Bitman B, Wang BC, Globe DR, Singh A,. Minimally important difference of Health Assessment Questionnaire in psoriatic arthritis: relating thresholds of improvement in functional ability to patient-rated importance and satisfaction. J Rheumatol 2011; 38: 2461-5.
23. Gladman DD, Mease PJ, Cifaldi MA, Perdok RJ, Sasso E, Medich J,. Adalimumab improves joint-related and skin-related functional impairment in patients with psoriatic arthritis: patient-reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial. Ann Rheum Dis 2007; 66: 163-8.
24. Fleischmann RM,. Comparison of the efficacy of biologic therapy for rheumatoid arthritis: can the clinical trials be accurately compared?. Rheum Dis Clin North Am 2006; 32 Suppl: 21-8.
25. Kavanaugh A, McInnes IB, Krueger GG, Gladman D, Beutler A, Gathany T, et al. Patient-reported outcomes and the association with clinical response in patients with active psoriatic arthritis treated with golimumab: findings through 2 years of a phase III, multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Care Res (Hoboken) 2013; 65: 1666-73.