Background Axial spondyloarthritis (axSpA) includes both ankylosing spondylitis (AS) and axSpA with no definitive sacroiliitis on X-ray (non-radiographic axSpA, nr-axSpA). These patients (pts) subgroups have similar clinical disease burden,1 however, the comparative health related Quality of Life (HRQoL) burden of these subgroups has been poorly researched. RAPID-axSpA (NCT01087762) investigated the effect of certolizumab pegol (CZP), a PEGylated Fc-free anti-TNF, which improves pt-reported outcomes (PROs) in rheumatoid arthritis,2 in axSpA.
Objectives To report the effect of CZP on PROs in axSpA, including AS and nr-axSpA pts.
Methods The ongoing 158-week (wk) Phase 3 RAPID-axSpA trial is double-blind and placebo (PBO)-controlled to Wk24.3 Recruited pts had adult-onset active axSpA according to the ASAS criteria,4 and included AS pts also meeting the modified New York criteria and nr-axSpA pts. 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). The primary endpoint was ASAS20 response at Wk12. Secondary PRO measures included physical function (BASFI), total back pain (NRS) and a daily pain diary to Wk4, fatigue (NRS from BASDAI), Ankylosing Spondylitis Quality of Life (AsQoL), and SF-36. Other PRO measures were Sleep Problems Index II domains of the MOS Sleep scale (MOS-SPI) and SF-36 domains. All PROs were analyzed in the full analysis set using analysis of covariance on change from baseline (BL) with LOCF imputation.
Results 325 pts were randomized. BL characteristics were similar between groups. Improvements in the CZP-treated arms were observed in pain NRS, fatigue NRS, BASFI and AsQoL from the first measurement at Wk1 through to Wk24 compared to PBO. Spinal pain was improved as early as day 2 after initiation of CZP compared to PBO. Pts in both CZP-treated dosage arms had greater improvements in MOS-SPI, SF-36 PCS, SF-36 MCS and SF-36 domains compared to PBO. More pts on CZP reached general population norms for SF-36 than pts on PBO. CZP had a similar impact on pain, fatigue and AsQoL in AS and nr-axSpA pts (Table). Relative to PBO pts, CZP treated nr-axSpA pts demonstrated a greater improvement in BASFI and sleep compared to AS pts (Table), and were more likely to reach population norms for SF-36.
Conclusions Both CZP dosing schedules rapidly improved all PRO including pain, fatigue, physical function and HRQoL of axSpA, in both AS and nr-axSpA pts.
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Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma.
Disclosure of Interest J. Sieper Consultant for: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly, Janssen, Speakers bureau: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly, Janssen, A. Kivitz Grant/research support from: Abbott, Pfizer, Merck, Janssen, Consultant for: Abbott, Pfizer, Merck, Janssen, A. van Tubergen Grant/research support from: Abbott, MSD, Pfizer, Roche, Consultant for: Abbott, Pfizer, UCB Pharma, Speakers bureau: Abbott, MSD, UCB Pharma, A. Deodhar Consultant for: UCB Pharma, G. Coteur Employee of: UCB Pharma, F. Woltering Shareholder of: UCB Pharma, Employee of: UCB Pharma, R. Landewé Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, Consultant for: Abbott, Ablynx, Amgen, AstraZeneca, BMS, Centocor, GSK, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, Speakers bureau: Abbott, Amgen, BMS, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth
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