SAT0260 Effect of Certolizumab Pegol on the Multiple Facets of Psoriatic Arthritis as Reported by Patients with and without Prior Anti-Tnf Exposure: 24-Week Patient-Reported Outcome Results of Rapid-PSA Study
Authors: D. Gladman, R. Fleischmann, G. Coteur, F. Woltering, P. J. Mease
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> Certolizumab pegol (CZP) is a PEGylated Fc-free anti-TNF that improves patient-reported outcomes (PROs) in rheumatoid arthritis.<sup>1</sup> The efficacy and safety of CZP in psoriatic arthritis (PsA) has been investigated in RAPID-PsA (NCT01087788).<sup>2</sup> <h3>Objectives</h3> To report the effect of CZP on PROs in PsA patients (pts), with and without prior anti-TNF exposure. <h3>Methods</h3> The ongoing 158-week (wk) Phase 3 RAPID-PsA trial was double-blind and placebo (PBO)-controlled to Wk24.<sup>2</sup> Recruited pts had active PsA, had failed ≥1 DMARD, and could have experienced secondary failure to 1 prior anti-TNF. Pts were randomized 1:1:1 to PBO every 2 wks (Q2W), or 400mg CZP at Wk0, 2 and 4 (loading dose) followed by either 200mg CZP Q2W or 400mg CZP every 4 wks (Q4W). Primary efficacy endpoints were ACR20 response at Wk12 and change from baseline (BL) to Wk24 in the van der Heijde modified Total Sharp Score. PRO measures evaluated: fatigue assessment scale (FAS), patient assessment of pain (VAS), health assessment questionnaire-disability index (HAQ-DI), health-related quality of life (HRQoL) measured by the SF-36 (physical component summary (PCS), mental component summary (MCS) scores and domain scores), PsAQoL, and Dermatology Life Quality Index (DLQI). Post-hoc analyses of PRO in pts with and without prior anti-TNF exposure were conducted. Change from BL for all PROs was analyzed for the randomized population using analysis of covariance, with LOCF imputation. <h3>Results</h3> 409 pts were randomized. 20% of pts had received a prior anti-TNF. BL demographics were similar between groups. Significant differences in pain, fatigue, HAQ-DI, HRQoL (SF-36 PCS, MCS and all domain scores), PsAQoL, and DLQI were observed in both CZP arms vs PBO (p&lt;0.001), irrespective of prior anti-TNF exposure (Table). Pain was significantly improved from Wk1, and fatigue and HAQ-DI from Wk2. More pts on CZP reached SF-36 general population norms than PBO pts. <h3>Image/graph</h3> <h3>Conclusions</h3> Both CZP dosing schedules effectively improved multiple PROs in pts with PsA across many facets of the disease. Rapid improvements were observed in pain, fatigue and HAQ-DI. 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 pts regardless of prior anti-TNF exposure. <h3>References</h3> Strand VS. Ann Rheum Dis 2011;70(6):996-1002, Mease P. Ann Rheum Dis 2012;71(Suppl3):150 <h3>Acknowledgements</h3> The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma. <h3>Disclosure of Interest</h3> D. Gladman Grant/research support from: Abbott, BMS, Celgene, Johnson &amp; Johnson, MSD, Novartis, Pfizer, UCB Pharma, Consultant for: Abbott, BMS, Celgene, Johnson &amp; Johnson, MSD, Novartis, Pfizer, UCB Pharma, R. Fleischmann Grant/research support from: Genetech Inc, Roche, Abbott, Amgen, UCB Pharma, Pfizer, BMS, Lilly, Sanofi-Aventis, Lexicon, MSD, Novartis, BiogenIdec, Astellas, AstraZeneca, Janssen, Consultant for: Roche, Abbott, Amgen, UCB Pharma, Pfizer, BMS, Lilly, Sanofi-Aventis, Lexicon, Novartis, Astellas, AstraZeneca, Janssen, HGS, G. Coteur Employee of: UCB Pharma, F. Woltering Shareholder of: UCB Pharma, Employee of: UCB Pharma, P. Mease Grant/research support from: Abbott, Amgen, BiogenIdec, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Consultant for: Abbott, Amgen, BiogenIdec, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Speakers bureau: Abbott, Amgen, BiogenIdec, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB Pharma