Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose
The impact of certolizumab pegol (CZP) on clinical and Magnetic Resonance Imaging outcomes in patients (pts) with axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS) and non-radiographic (nr-) axSpA, has been described previously.1 However, structural progression in these pts measured by X-ray has not been previously reported. The objective of this report is to present structural progression, assessed using X-ray, over 96 weeks (wks) of CZP treatment in the RAPID-axSpA study (NCT01087762).2
RAPID-axSpA, 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 had adult-onset active axSpA. 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. X-ray assessment of the anterior vertebral edges of the cervical and lumbar spine was conducted using the modified Stokes Ankylosing Spondylitis Spine Score (mSASSS) at baseline (BL) and Wk96. X-rays were recorded in a subset of pts, and results reported for pts initially randomized to CZP with both available BL and Wk96 X-ray measurements (observed case). Definite mSASSS progression was defined as an mSASSS increase ≥2 units, and was assessed over 96 wks. Unadjusted descriptive analyses investigated mSASSS disease activity and response in subgroups of pts.
Results
218 pts were randomized to receive CZP, of which 109 were included in the imaging set, and 89 had both BL and Wk96 X-rays available for analysis. 22.2% of CZP pts in the imaging set had evidence of structural changes in the spine (mSASSS≥2, with ≥1syndesmophyte) at BL (32.3% of AS and 8.7% of nr-axSpA pts). Mean mSASSS at BL was 8.0 in axSpA pts. As expected, BL damage was more severe in AS pts compared to the nr-axSpA population (11.1 vs 3.2, Table). Over 96 wks of CZP treatment, mean mSASSS score of the axSpA population increased by 0.4 units, and 9.0% of pts experienced definite mSASSS progression ≥2 units. Radiographic progression was greater in AS pts compared to nr-axSpA pts (change from BL: 0.6 vs 0.2, definite mSASSS progression 13.0% vs 2.9%). A number of BL characteristics appeared to influence mSASSS progression over 96 wks (Table). However, these are unadjusted analyses, therefore further investigation is underway to determine whether these observations are influenced by confounding BL factors.
Conclusion
Limited radiographic progression was seen over 96 wks in CZP-treated pts. Further analyses are needed to confirm which subgroups of pts have an increased risk of progression.
1. van der Heijde D. Arthritis Rheum 2012;64(Suppl 10):S730
2. Landewé R. Ann Rheum Dis 2014;73:39-47
Disclosure:
D. M. 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;
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;
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.
ACR Meeting Abstracts - https://acrabstracts.org/abstract/structural-progression-of-the-spine-measured-by-x-ray-in-patients-with-axial-spondyloarthritis-treated-with-certolizumab-pegol-over-96-weeks-including-ankylosing-spondylitis-and-non-radiographic-axia/