TBA (17A200)

Four Year Imaging Outcomes in Axial Spondyloarthritis Patients Treated with Certolizumab Pegol, Including Patients with Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis

Author(s)

E. McGarry,1 D. van der Heijde,2 X. Baraliakos,3 K. G. Hermann,4 R. Landewé,5 P. M. Machado,6 W. P. Maksymowych,7 O. Davies,8 N. de Peyrecave,8 B. Hoepken,9 L. Bauer,9 T. Nurminen,9 J. Braun10

Department(s)/Institutions

1UCB Pharma, Dublin, Ireland; 2Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands; 3Ruhr-University Bochum, Herne, Germany; 4Charité Medical School, Berlin, Germany; 5Academic Medical Center, Amsterdam & Atrium Medical Center Heerlen, Netherlands; 6Centre for Rheumatology Research & MRC Centre for Neuromuscular Diseases, University College London, London, UK; 7Department of Medicine, University of Alberta, Edmonton, Alberta, Canada; 8UCB Pharma, Slough, UK; 9UCB Pharma, Monheim, Germany; 10Rheumazentrum Ruhrgebiet, Herne, Germany. 

Introduction

RAPID-axSpA (NCT01087762) was a long-term study in patients (pts) with axial spondyloarthritis (axSpA) treated with certolizumab pegol (CZP).

Aims/Background

his is the first report of 4-year imaging results in CZP-treated axSpA pts, including ankylosing spondylitis (AS) and non-radiographic (nr-)axSpA.

Method

RAPID-axSpA was double-blind, placebo (PBO)-controlled to Wk24, dose-blind to Wk48 and open-label to Wk204. Pts fulfilling ASAS axSpA criteria were stratified according to presence/absence of radiographic sacroiliitis (AS/nr-axSpA) at randomization, and had active disease. Wk0 CZP-randomized pts (200 mg Q2W/400 mg Q4W) continued assigned dose; PBO pts received CZP after Wk 16 or 24. Lateral X-rays of cervical/lumbar spine at BL, Wk 96 and 204 were assessed using mSASSS (average of 2 independent central readers blind to timepoint). SI joint X-rays were scored for sacroiliitis by 2 independent central readers (3rd reader adjudicated grade scoring differences) at BL and Wk 204. MRI scans using STIR sequences were performed at BL, Wk 12, 48, 96 and 204, and were assessed using SPARCC for SI joints and Berlin score for spine. Data are shown for CZP-treated pts (including those starting on PBO). mSASSS data were estimated for all pts by MMRM analysis covering all available observations. MRI data at each timepoint are shown as observed for pts with a valid assessment at that timepoint. SI joint X-ray data were assessed in pts with valid assessments at both BL and Wk 204. 

Results

Of 315 CZP-treated pts, 196 had available spinal X-rays and were included in MMRM analysis (BL mean mSASSS: 9.47). 158 pts had MRI assessments and were included in this reading campaign (BL mean SPARCC: 8.17 [n=151]; Berlin: 6.10 [n=153]) and 137 pts had SI Joint X-rays at BL and Wk 204 (BL: 67.9% radiographic sacroiliitis). In AS pts, mean mSASSS change between BL and Wk 204 was 0.98 (95% CI: 0.34–1.63); 0.67 (0.21–1.13) from BL to Wk 96 and 0.31 (0.02–0.60) from Wk 96 to Wk 204. These numbers were 0.06 (-0.17–0.28), -0.01 (-0.19–0.17), and 0.07 (-0.07–0.20) respectively for nr-axSpA. MMRM estimates were similar to observed values (axSpA Wk 204 mean change: 0.62 and 0.70 respectively). Limited changes in SI joint X-ray grading were observed to Wk 204: only 2/44 pts (4.5%) progressed to AS, while 4/93 (4.3%) shifted from an AS classification to nr-axSpA. MRI assessments showed maintained improvements in SPARCC and Berlin scores from Wk 12 to Wk 204 (Table).

Conclusions

This is the first report of imaging data from a clinical trial including both AS and nr-axSpA pts over 4 years. Limited spinal radiographic progression was observed in CZP-treated pts with lower progression between Wk 96 and Wk 204, compared to the first 96 wks. Limited change in radiographic sacroiliitis was observed and scores were even similar in both directions. Early reductions in MRI inflammation were maintained to Wk 204.

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