Effect of certolizumab pegol over 96 weeks in patients with psoriatic arthritis with and without prior antitumour necrosis factor exposure

RMD Open

Volumn 1, Issue 1, 2015, Pages

  Mease, P ^a   Deodhar, A ^b   Fleischmann, R ^c   Wollenhaupt, J ^d   Gladman, D ^e   Leszczynski P ^f,g   Vitek, P ^h   Turkiewicz, A ⁱ   Khraishi, M ^j   FitzGerald, O ^k   Landewe R ^l   De Longueville, M ^m   Hoepken, B ^m   Peterson, L ^m   Van Der Heijde, D ⁿ  

^a UNIVERSITY OF WASHINGTON   (United States)

^b OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^c UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^d Schoen Klinik   (Germany)

^e UNIVERSITY HEALTH NETWORK   (Canada)

^f POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

^g Jozef Strus Hospital   (Poland)

^h Revmavita Centre   (Czech Republic)

ⁱ Rheumatology Associates   (United States)

^j MEMORIAL UNIVERSITY OF NEWFOUNDLAND   (Canada)

^k ST VINCENT S UNIVERSITY HOSPITAL   (Ireland)

^l ACADEMIC MEDICAL CENTER   (Netherlands)

^m UCB PHARMA   (Belgium)

ⁿ LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85018193185     PISSN: None     EISSN: 20565933     Source Type: Journal    
DOI: 10.1136/rmdopen-2015-000119     Document Type: Article

References (23)

1. Lee S, Mendelsohn A, Sarnes E. The burden of psoriatic arthritis: a literature review from a global health systems perspective. P T 2010;35:680-9.
2. Myers WA, Gottlieb AB, Mease P. Psoriasis and psoriatic arthritis: clinical features and disease mechanisms. Clin Dermatol 2006;24:438-47.
3. Mease PJ, Menter MA. Quality-of-life issues in psoriasis and psoriatic arthritis: outcome measures and therapies from a dermatological perspective. J Am Acad Dermatol 2006;54:685-704.
4. Mease PJ, van Tubergen A, Deodhar A, et al. Comparing health-related quality of life across rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: analyses from certolizumab pegol clinical trial baseline data. Ann Rheum Dis 2013;72:766.
5. Mease PJ, Fleischmann R, Deodhar A, et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis 2014;73:48-55.
6. van der Heijde D, Fleischmann R, Wollenhaupt J, et al. Effect of different imputation approaches on the evaluation of radiographic progression in patients with psoriatic arthritis: results of the RAPIDPsA 24-week phase III double-blind randomised placebo-controlled study of certolizumab pegol. Ann Rheum Dis 2014;73:233-7.
7. Gladman D, Fleischmann R, Coteur G, et al. 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 Res 2014;66:1085-92.
8. Taylor W, Gladman D, Helliwell P, et al. Classification Criteria for Psoriatic Arthritis: development of new criteria from a large international study. Arthritis Rheum 2006;54:2665-73.
9. Coates LC, Fransen J, Helliwell PS. Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment. Ann Rheum Dis 2010;69:48-53.
10. 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 2011;63:S64-85.
11. van der Heijde D, Sharp J,Wassenberg S, et al. Psoriatic arthritis imaging: a review of scoring methods. Ann Rheum Dis 2005;64:ii61-4.
12. Smolen JS, Emery P, Ferraccioli GF, et al. Certolizumab pegol in rheumatoid arthritis patients with low to moderate activity: the CERTAIN double-blind, randomised, placebo-controlled trial. Ann Rheum Dis 2015;74:843-50.
13. Mease P, Fleischmann R, Wollenhaupt J, et al. Effect of certolizumab pegol over 48 weeks on signs and symptoms in patients with psoriatic arthritis with and without prior tumor necrosis factor inhibitor exposure. Arthritis Rheum 2013;65:S132-3.
14. Glintborg B, ?stergaard M, Krogh NS, et al. Clinical response, drug survival, and predictors thereof among 548 patients with psoriatic arthritis who switched tumor necrosis factor α inhibitor therapy: results from the Danish Nationwide DANBIO Registry. Arthritis Rheum 2013;65:1213-23.
15. Ritchlin C, McInnes I, Kavanaugh A, et al. Maintenance of efficacy and safety of ustekinumab in patients with active psoriatic arthritis despite prior conventional nonbiologic and anti-TNF biologic therapy: 1 yr results of the PSUMMIT 2 trial. Ann Rheum Dis 2013;72:A48-A.
16. LaVange LM. The role of statistics in regulatory decision making. Ther Innov Regul Sci 2014;48:10-19.
17. Gladman D, Fleischmann R, Coteur G, et al. 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 Res (Hoboken) 2014;66:1085-92.
18. Papp KA, Fonjallaz P, Casset-Semanaz F, et al. Analytical approaches to reporting long-term clinical trial data. Curr Med Res Opin 2008;24:2001-8.
19. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 1999;319:670-4.
20. Kavanaugh A, Antoni CE, Gladman D, et al. The infliximab multinational psoriatic arthritis controlled trial (IMPACT): results of radiographic analyses after 1 year. Ann Rheum Dis 2006;65:1038-43.
21. Mease PJ, Kivitz AJ, Burch FX, 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.
22. Kavanaugh A, van der Heijde D, McInnes IB, et al. Golimumab in psoriatic arthritis: one-year clinical efficacy, radiographic, and safety results from a phase III, randomized, placebo-controlled trial. Arthritis Rheum 2012;64:2504-17.
23. Gladman DD, Mease PJ, Ritchlin CT, 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.