Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose
Previous results from RAPID-axSpA (NCT01087762) demonstrated that certolizumab pegol (CZP) reduced inflammation in the sacroiliac joints (SIJ) and spine, as assessed by Magnetic Resonance Imaging (MRI), after 12 weeks (wks) of therapy in patients (pts) with axial spondyloarthritis (axSpA) and in both ankylosing spondylitis (AS) and non-radiographic (nr-) axSpA subpopulations.1 The objective of this report is to present MRI outcomes from RAPID-axSpA to Wk96.
RAPID-axSpA,2 a Phase 3 study in axSpA pts, is double-blind and placebo-controlled to Wk24, dose-blind to Wk48 and open-label (OL) to Wk204. Pts originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks 0, 2, 4), continued on their assigned dose in dose-blind and OL phases. MRI scans of the SIJ and spine,3 using short-tau-inversion recovery sequences, were performed at baseline (BL) (±3 days), Wk12, Wk48 and Wk96. MRI endpoints were change from BL in the Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ score for inflammation and in the Berlin modification of AS spine MRI score for disease activity in the spine (ASspiMRI-a). MRIs were recorded in a subset of pts, and results reported for pts randomized to CZP using all observed MRI measurements.
Results
218 pts were randomized to receive CZP, of which 109 were included in the MRI set. 27 pts (24.8%) reported inflammation of SIJ (SPARCC≥2), but no spinal involvement (ASspiMRI-a≤2); 17 (15.6%) reported spine inflammation without SIJ involvement; and 31 (28.4%) reported inflammation of spine and SIJ. Mean BL SPARCC was similar between AS and nr-axSpA pts (7.2 in both groups), but mean BL ASspiMRI-a score was higher in AS pts (AS: 5.3 vs nr-axSpA: 2.8). Rapid improvement in SPARCC SIJ and ASspiMRI-a scores was observed at Wk12 and sustained to Wk96 (Table). Similar results were observed for both CZP dose regimens (data not shown). Similar improvement in SPARCC SIJ score was observed in AS and nr-axSpA pts. While improvement in spinal inflammation was observed in both AS and nr-axSpA pts, nr-axSpA pts had a lower mean ASspiMRI-a score at all time points.
Conclusion
Previously reported improvements in MRI scores at Wk12 were maintained to Wk96 in axSpA, AS and nr-axSpA pts.
References
1. van der Heijde D. Arthritis Rheum 2012;64(Suppl 10):S730
2. Landewé R. Ann Rheum Dis 2014;73:39-47
3. Lambert R. Arthritis Rheum 2007;56(12):4005-4040
Disclosure:
J. Braun,
Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma,
5,
Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma,
2;
W. P. Maksymowych,
AbbVie, Amgen, BMS, Eli Lilly, Janssen, Merck, Pfizer, Synarc, UCB Pharma,
2,
AbbVie, Amgen, BMS, Eli Lilly, Janssen, Merck, Pfizer, Synarc, UCB Pharma,
5;
R. B. M. Landewé,
Abbott, Ablynx, Amgen, Astra-Zeneca, Bristol Myers Squibb, Centocor, Glaxo-Smith-Kline, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth,
5,
Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth,
2,
Abbott, Amgen, Bristol Myers Squibb, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth,
8;
C. Stach,
UCB Pharma,
3,
UCB Pharma,
1;
O. Davies,
UCB Pharma,
3,
UCB Pharma,
1;
T. Nurminen,
UCB Pharma,
3;
D. van der Heijde,
AbbVie, Amgen, AstraZeneca, Augurex, BMS, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, Galapagos, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB Pharma, Vertex,
5,
Imaging Rheumatology bv,
9.
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