Background Psoriatic arthritis (PsA) is a heterogeneous inflammatory disease that has a substantial impact on patients' (pts) physical and emotional wellbeing.1 Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-TNF that has been shown to improve patient-reported outcomes (PROs) in pts with PsA over 96 weeks (wks) of treatment in the RAPID-PsA study (NCT01087788).2
Objectives To investigate whether initial improvements in PROs observed with CZP treatment were maintained over 4 years in the RAPID-PsA study.
Methods RAPID-PsA was double-blind and placebo-controlled to Wk24, dose-blind to Wk48, and open-label to Wk216. Pts were aged ≥18 years, with a diagnosis of active PsA, and had failed treatment with ≥1 DMARD. Pts originally randomized to CZP (400mg at Wks0,2,4 [loading dose] followed by either 200mg every 2 wks [Q2W] or 400mg every 4 wks [Q4W]) continued on their assigned dose during the open-label period. PROs assessed included Patient's Global Assessment of Arthritis Pain (PtAAP; visual analog scale), fatigue (numeric rating scale), Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 Physical and Mental Component Summary (SF-36 PCS/MCS), Psoriatic Arthritis Quality of Life (PsAQoL), and Dermatology Life Quality Index (DLQI; assessed in the subgroup of pts with ≥3% body surface area affected by psoriasis at baseline [BL]). Data are reported as the mean change from BL (CFB) for pts randomized to CZP at Wk0, with last observation carried forward (LOCF) imputation for Wk24, and LOCF imputation and observed case (OC) values for Wk216.
Results Of 273 pts randomized to CZP at Wk0, 248 (91%) completed Wk24 and 183 (67%) completed Wk216. Improvements observed to Wk24 of treatment were generally maintained over 4 years (to Wk216) in all PROs assessed, regardless of prior anti-TNF exposure (Table). Similar improvements were observed in both CZP dose regimens for all PROs examined, including PtAAP (CFB at Wk216 in the 200mg Q2W group [with LOCF imputation]: -30.5, in the 400mg Q4W group: -33.8); fatigue (-2.3, -2.3); HAQ-DI (-0.50, -0.49); SF-36 PCS (8.73, 8.77); SF-36 MCS (3.91, 3.28); PsAQoL (-4.6, -4.4); and DLQI (-8.4, -6.8).
Conclusions Early improvements with CZP treatment were maintained over 4 years in all PROs assessed in the RAPID-PsA study. Similar improvements were observed in pts with and without prior anti-TNF exposure, and in both CZP dose regimens.
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Gladman D. Value in Health 2014;17(7):A386.
Acknowledgements This study was funded by UCB Pharma. We thank the patients and their caregivers in addition to the investigators and their teams who contributed to this study. Editorial services were provided by Costello Medical Consulting.
Disclosure of Interest D. Gladman Grant/research support from: Abbott, Bristol-Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, UCB Pharma, Consultant for: Abbott, Bristol-Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, UCB Pharma, R. Fleischmann Grant/research support from: Genentech Inc, Roche, Abbott, Amgen, UCB Pharma, Pfizer, Bristol-Myers Squibb, Lilly, Sanofi-Aventis, MSD, Novartis, AstraZeneca, Janssen, Consultant for: Roche, Abbott, Amgen, UCB Pharma, Pfizer, Bristol-Myers Squibb, Lilly, Sanofi-Aventis, Novartis, AstraZeneca, Janssen, K. Harris Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, P. Mease Grant/research support from: (Abbott) AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB Pharma, Consultant for: (Abbott) AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo, Corrona, Dermira, Janssen, Lilly, Merck, Novartis, Pfizer, Sun, UCB Pharma, Zynerba, Speakers bureau: (Abbott) AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo, Genentech, Janssen, Novartis, Pfizer, UCB Pharma