EFFECT OF CERTOLIZUMAB PEGOL ON THE MULTIPLE FACETS OF PSORIATIC ARTHRITIS AS REPORTED BY PATIENTS- 24 WEEK PATIENT REPORTED OUTCOME RESULTS OF A PHASE 3 DOUBLE BLIND RANDOMIZED PLACEBO-CONTROLLED STUDY
Author(s)
Gladman D1;Fleischmann R2;Coteur G*3;Woltering F4, Mease P5 1University of Toronto, Toronto, ON, Canada, 2Metroplex Clinical Research Center, Dallas, TX, USA, 3UCB Pharma, Brussels, Belgium, 4UCB Pharma, Monheim, Germany, 5Swedish Medical Center, Seattle, WA, USA
OBJECTIVES: To report the effect of certolizumab pegol (CZP), a PEGylated Fc-free anti-TNF, on patient reported outcomes (PRO) in psoriatic arthritis (PsA), as investigated in RAPID-PsA (NCT01087788). METHODS: The ongoing 158 week (Wk) RAPID-PsA trial is double blind and placebo-controlled to Wk24. Recruited patients had active PsA and had failed ≥1 DMARD. Patients could have received 1 previous anti-TNF. Patients were randomized 1:1:1 to placebo, or 400mg CZP at Wk 0, 2 and 4 (loading dose) followed by either 200mg CZP every 2 weeks (Q2W) or 400mg CZP every 4 weeks (Q4W). PRO measures evaluated: fatigue assessment scale (FAS), patient assessment of pain (VAS), health assessment questionnaire-disability index (HAQ-DI), SF-36, PsAQoL, and the Dermatology Life Quality Index (DLQI). Change from baseline for PRO was analyzed for the randomized population, with LOCF imputation. RESULTS: A total of 409 patients were randomized. 20% of patients had received a prior anti-TNF. Baseline demographics were similar between groups. From baseline to Wk24, differences in pain (-11.2 vs. -28.6 and -28.4), fatigue (-0.6 vs. -2.2 and -1.9), HAQ-DI (-0.19 vs. -0.54 and -0.46), SF-36 physical component summary (2.14 vs. 8.43 and 7.58) and mental component summary (0.73 vs 5.49 and 3.49), PsAQoL (-1.27 vs. -4.43 and -3.30), and DLQI (-1.4 vs. -6.3 and -5.2) were observed in placebo vs. CZP 200mg Q2W and 400mg Q4W arms (p<0.001). Differences were observed from Wk1 and were irrespective of prior anti-TNF exposure. More patients on CZP reached SF-36 general population norms than placebo patients. CONCLUSIONS: CZP effectively improved multiple PROs in PsA patients across many disease facets. The benefits of CZP treatment on physical and emotional components of HRQoL were seen across generic, PsA-specific and dermatology-specific measures. These benefits were seen in patients regardless of prior anti-TNF exposure.
Conference/Value in Health Info
2013-05, ISPOR 2013, New Orleans, LA, USA
Value in Health, Vol. 16, No. 3 (May 2013)
Code
PMS51
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Musculoskeletal Disorders