CERTOLIZUMAB PEGOL IS ASSOCIATED WITH LONG-TERM IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES IN PSORIATIC ARTHRITIS- 4-YEAR OUTCOMES FROM THE RAPID-PSA STUDY
Author(s)
Gladman D1, Fleischmann R2, Harris K3, Peterson L4, Mease PJ5
1University of Toronto, Toronto, ON, Canada, 2University of Texas Southwestern Medical Center, Dallas, TX, USA, 3UCB Pharma, Brussels, Belgium, 4UCB Pharma, Raleigh, NC, USA, 5Swedish Medical Center and University of Washington, Seattle, WA, USA
OBJECTIVES: To investigate whether early improvements in patient-reported outcomes (PROs) observed with certolizumab pegol (CZP) treatment were maintained over 4 years in the RAPID-PsA trial of patients with psoriatic arthritis (PsA). METHODS: RAPID-PsA (NCT01087788) was double-blinded and placebo-controlled to Week (Wk)24, dose-blinded to Wk48 and open-label to Wk216. Patients had active PsA and had failed ≥1 DMARD. Patients originally randomized to CZP (200mg every 2 wks or 400mg every 4 wks, following 400mg loading dose at Wks 0, 2, 4) continued on assigned dose in the open-label period. PROs assessed included patient’s global assessment of arthritis pain (visual analogue scale), fatigue (numeric rating scale), HAQ-DI, SF-36 PCS, SF-36 MCS, PsAQoL, and DLQI (DLQI was assessed in the subgroup of patients with ≥3% body surface area affected by psoriasis at baseline). Data are reported for patients originally randomized to CZP at Wk0 as mean change from baseline, imputed by LOCF. RESULTS: Of 273 patients randomized to CZP at Wk0, 248 (91%) completed Wk24 and 183 (67%) Wk216. Early improvements observed to Wk24 of CZP treatment were subsequently maintained over 4 years (to Wk216) in all PROs assessed, including patient’s global assessment of arthritis pain (Wk24: -28.5; Wk216: -32.1), fatigue (Wk24: -2.0; Wk216: -2.3), HAQ-DI (Wk24: -0.5; Wk216: -0.5), SF-36 PCS (Wk24: 8.0; Wk216: 8.8), SF-36 MCS (Wk24: 4.5; Wk216: 3.6), PsAQoL (Wk24: -3.9; Wk216: -4.5), and DLQI (Wk24: -7.6; Wk216: -7.6). Similar improvements were observed with both CZP dose regimens and in patients with and without prior anti-TNF exposure (data not shown). CONCLUSIONS: Early improvements observed with CZP treatment to Wk24 in all PROs assessed were subsequently maintained over 4 years in patients with PsA. Similar maintained improvements were observed in both CZP dose regimens, and in patients with and without prior anti-TNF exposure.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PSY110
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Systemic Disorders/Conditions