LONG-TERM MAINTENANCE OF IMPROVEMENTS IN MULTIPLE FACETS OF PSORIATIC ARTHRITIS WITH CERTOLIZUMAB PEGOL- 48-WEEK PATIENT-REPORTED OUTCOME RESULTS OF THE RAPID-PSA STUDY
Author(s)
Gladman D1;Fleischmann R2;Coteur G*3;Peterson L4, Mease PJ5 1University of Toronto, Toronto, Ontario, ON, Canada, 2Metroplex Clinical Research Center, Dallas, TX, USA, 3UCB Pharma, Brussels, Belgium, 4UCB Pharma, Raleigh, NC, USA, 5Swedish Medical Center
OBJECTIVES: To report the effect of certolizumab pegol (CZP), a PEGylated Fc-free anti-TNF, on patient-reported outcomes (PROs) in psoriatic arthritis (PsA) over 48 weeks (wks) in the RAPID-PsA trial. METHODS: The ongoing RAPID-PsA trial (NCT01087788) is double-blind and placebo-controlled to Wk24 and dose-blind to Wk48. Patients (pts) had active PsA and had failed ≥1 DMARD. Pts originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks 0, 2, 4) continued on their assigned dose in dose-blind phase; placebo pts entering dose-blind phase were re-randomized to CZP loading dose followed by CZP 200mg Q2W or 400mg Q4W. We report efficacy data for the randomised set (RS) of pts originally randomized to CZP. Mean changes from baseline in patient assessment of pain (VAS), fatigue assessment scale (NRS), HAQ-DI, SF-36, PsAQoL and Dermatology Life Quality Index (DLQI) were assessed with LOCF imputation. RESULTS: Of 138 and 135 pts randomized to CZP 200mg Q2W and 400mg Q4W, 128 (92.8%) and 120 (88.9%) completed the double-blind period, and 123 (89.1%) and 114 (84.4%) completed the dose-blind period, respectively. Rapid improvements from baseline to Wk24 observed in double-blind period were maintained to Wk48 for pain (Wk24: -28.6 and -28.4; Wk48: -31.6 and -29.5), fatigue (Wk24: -2.2 and -1.9; Wk48: -2.4 and -2.0), HAQ-DI (Wk24: -0.52 and -0.43; Wk48: -0.56 and -0.49), SF-36 physical component summary (Wk24: 8.4 and 7.6; Wk48: 8.6 and 8.4) and mental component summary (Wk24: 5.5 and 3.5; Wk48: 4.8 and 3.2), PsAQoL (Wk24: -4.4 and -3.3; Wk48: -4.8 and -3.5), and DLQI (Wk24: -6.3 and -5.2; Wk48: -6.2 and -5.6) for CZP 200mg Q2W and 400mg Q4W patients, respectively. CONCLUSIONS: Improvements in generic and disease-specific PROs observed over 24 wks were sustained over 48 wks in CZP-treated PsA pts. Improvements were observed regardless of CZP dose regimen.
Conference/Value in Health Info
2013-11, ISPOR Europe 2013, The Convention Centre Dublin
Value in Health, Vol. 16, No. 7 (November 2013)
Code
PMS81
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Musculoskeletal Disorders