ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1042

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

Desiree van der Heijde1, Xenofon Baraliakos2, Kay-Geert Hermann3, Robert Landewé4, Pedro Machado5, Walter Maksymowych6, Owen Davies7, Natasha de Peyrecave7, Bengt Hoepken8, Lars Bauer8, Tommi Nurminen8 and Jürgen Braun9, 1Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 2Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany, 3Charité – University Medicine Berlin, Berlin, Germany, 4Rheumatology, Academic Medical Center, Amsterdam & Zuyderland Medical Center Heerlen, Amsterdam, Netherlands, 5Centre for Rheumatology Research & MRC Centre for Neuromuscular Diseases, University College London, London, United Kingdom, 6Medicine, Department of Medicine, University of Alberta, Edmonton, AB, Canada, 7UCB Pharma, Slough, United Kingdom, 8UCB Pharma, Monheim, Germany, 9Rheumazentrum Ruhrgebiet, Herne, Germany

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: , ,

Session Information

Date: Sunday, November 13, 2016

Title: Spondylarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment II: Axial Spondyloarthritis – Treatment

Session Type: ACR Concurrent Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: RAPID-axSpA (NCT01087762) was a long-term study in patients (pts) with axial spondyloarthritis (axSpA) treated with certolizumab pegol (CZP). This is the first report of 4-year imaging results in CZP-treated axSpA pts, including ankylosing spondylitis (AS) and non-radiographic (nr-)axSpA.

Methods: RAPID-axSpA1 was double-blind, placebo (PBO)-controlled to Wk 24, dose-blind to Wk 48 and open-label to Wk 204. Pts fulfilling ASAS axSpA criteria were stratified according to presence/absence of radiographic sacroiliitis (AS/nr-axSpA) at randomization, and had active disease. Wk 0 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 (Table). 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).

Conclusion: 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. References: 1. Landewé R. Ann Rheum Dis 2014;73:39

Disclosure: D. van der Heijde, AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Celgene, Daiichi, Eli Lilly, Galapagos, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB Pharma, 5,Director of Imaging Rheumatology bv, 3; X. Baraliakos, AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Chugai, Janssen, MSD, Novartis, Pfizer and UCB Pharma, 2,AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Chugai, Janssen, MSD, Novartis, Pfizer and UCB Pharma, 5,AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Chugai, Janssen, MSD, Novartis, Pfizer and UCB Pharma, 9; K. G. Hermann, AbbVie, MSD, Pfizer and UCB Pharma, 8; R. Landewé, Abbott, Ablynx, Amgen, AstraZeneca, 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; P. Machado, AbbVie, Centocor, Janssen, MSD, Novartis and Pfizer, 5,AbbVie, Centocor, Janssen, MSD, Novartis and Pfizer, 9; W. Maksymowych, AbbVie, Amgen, Eli Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi, UCB Pharma, 2,AbbVie, Amgen, Eli Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi, UCB Pharma, 5,AbbVie, Amgen, Eli Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi, UCB Pharma, 9; O. Davies, UCB Pharma, 3; N. de Peyrecave, UCB Pharma, 3; B. Hoepken, UCB Pharma, 3; L. Bauer, UCB Pharma, 3; T. Nurminen, UCB Pharma, 3; J. Braun, Abbott, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, 2,Abbott, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, 5.

To cite this abstract in AMA style:

van der Heijde D, Baraliakos X, Hermann KG, Landewé R, Machado P, Maksymowych W, Davies O, de Peyrecave N, Hoepken B, Bauer L, Nurminen T, Braun J. Four Year Imaging Outcomes in Patients with Axial Spondyloarthritis Treated with Certolizumab Pegol, Including Patients with Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/four-year-imaging-outcomes-in-patients-with-axial-spondyloarthritis-treated-with-certolizumab-pegol-including-patients-with-ankylosing-spondylitis-and-non-radiographic-axial-spondyloarthritis/. Accessed .

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