Background Certolizumab pegol (CZP) is a PEGylated Fc-free anti-TNF that improves patient-reported outcomes (PROs) in rheumatoid arthritis.1 The efficacy and safety of CZP in psoriatic arthritis (PsA) has been investigated in RAPID-PsA (NCT01087788).2
Objectives To report the effect of CZP on PROs in PsA patients (pts), with and without prior anti-TNF exposure.
Methods The ongoing 158-week (wk) Phase 3 RAPID-PsA trial was double-blind and placebo (PBO)-controlled to Wk24.2 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.
Results 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<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.
Conclusions 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.
Strand VS. Ann Rheum Dis 2011;70(6):996-1002,
Mease P. Ann Rheum Dis 2012;71(Suppl3):150
Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma.
Disclosure of Interest D. Gladman Grant/research support from: Abbott, BMS, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, UCB Pharma, Consultant for: Abbott, BMS, Celgene, Johnson & 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