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Tytuł pozycji:

Limited radiographic progression and sustained reductions in MRI inflammation in patients with axial spondyloarthritis: 4-year imaging outcomes from the RAPID-axSpA phase III randomised trial.

Tytuł:
Limited radiographic progression and sustained reductions in MRI inflammation in patients with axial spondyloarthritis: 4-year imaging outcomes from the RAPID-axSpA phase III randomised trial.
Autorzy:
van der Heijde D; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Baraliakos X; Ruhr-University Bochum, Herne, Germany.
Hermann KA; Department of Radiology, Charité Medical School, Berlin, Germany.
Landewé RBM; Academic Medical Center, Amsterdam and Atrium Medical Center, Heerlen, The Netherlands.
Machado PM; Centre for Rheumatology and MRC Centre for Neuromuscular Diseases, University College London, London, UK.
Maksymowych WP; Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Davies OR; UCB Celltech, Slough, UK.
de Peyrecave N; UCB Celltech, Slough, UK.
Hoepken B; UCB Pharma, Monheim, Germany.
Bauer L; UCB Pharma, Monheim, Germany.
Nurminen T; UCB Pharma, Monheim, Germany.
Braun J; Rheumazentrum Ruhrgebiet, Herne, Germany.
Źródło:
Annals of the rheumatic diseases [Ann Rheum Dis] 2018 May; Vol. 77 (5), pp. 699-705. Date of Electronic Publication: 2018 Jan 17.
Typ publikacji:
Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Język:
English
Imprint Name(s):
Publication: London : BMJ
Original Publication: London : H.K. Lewis
MeSH Terms:
Disease Progression*
Antirheumatic Agents/*therapeutic use
Certolizumab Pegol/*therapeutic use
Magnetic Resonance Imaging/*methods
Spondylarthritis/*diagnostic imaging
Adult ; Double-Blind Method ; Female ; Humans ; Induction Chemotherapy ; Inflammation/diagnostic imaging ; Male ; Middle Aged ; Radiography ; Sacroiliac Joint/diagnostic imaging ; Severity of Illness Index ; Spine/diagnostic imaging ; Spondylarthritis/drug therapy ; Spondylarthritis/pathology ; Treatment Outcome
References:
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Contributed Indexing:
Keywords: ankylosing spondylitis; anti-tnf; inflammation; magnetic resonance imaging; spondyloarthritis
Substance Nomenclature:
0 (Antirheumatic Agents)
UMD07X179E (Certolizumab Pegol)
Entry Date(s):
Date Created: 20180119 Date Completed: 20190114 Latest Revision: 20190114
Update Code:
20240104
PubMed Central ID:
PMC5909752
DOI:
10.1136/annrheumdis-2017-212377
PMID:
29343510
Czasopismo naukowe
Objectives: To report 4-year imaging outcomes in the RAPID-axSpA (NCT01087762) study of patients with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA), treated with certolizumab pegol (CZP).
Methods: This phase III, randomised trial was placebo-controlled and double-blind to week 24, dose-blind to week 48 and open-label to week 204. Patients fulfilling the Assessment of Spondyloarthritis International Society (ASAS) axSpA criteria with active disease were stratified (AS/nr-axSpA) according to the modified New York (mNY) criteria at randomisation. Spinal radiographs were assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). MRI inflammation used the Spondyloarthritis Research Consortium of Canada (SPARCC) score for sacroiliac joints (SIJ) and the Berlin spinal score (remission defined as SPARCC <2 and Berlin ≤2, respectively).
Results: MRI improvements from baseline (BL) to week 12 were maintained to week 204 (SPARCC BL: AS=8.5, nr-axSpA=7.5; SPARCC week 204: AS=1.3, nr-axSpA=2.4; Berlin BL: AS=7.4, nr-axSpA=4.4; Berlin week 204: AS=2.6, nr-axSpA=1.9). 66.7% of patients with AS and 69.6% of patients with nr-axSpA with BL SPARCC scores ≥2, and 65.4% of patients with AS and 57.3% of patients with nr-axSpA with BL Berlin score >2, achieved remission at week 204. Mean mSASSS change in AS from BL to week 204 was 0.98 (95% CI 0.34, 1.63); 0.67 (95% CI 0.21,1.13) from BL to week 96; and 0.31 (95% CI 0.02,0.60) from week 96 to week 204. Corresponding nr-axSpA changes were 0.06 (95% CI -0.17,0.28), -0.01 (95% CI -0.19,0.17) and 0.07 (95% CI -0.07,0.20). 4.5% of patients with nr-axSpA fulfilled the mNY criteria at week 204, while 4.3% of patients with AS no longer did so.
Conclusions: In patients with CZP-treated axSpA, rapid decreases in spinal and SIJ MRI inflammation were maintained to week 204. Overall, 4-year spinal progression was low, with less progression during years 2-4 than 0-2. Radiographic SIJ grading changes demonstrated limited progression.
Trial Registration Number: NCT01087762; Post-results.
Competing Interests: Competing interests: DvdH has received consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi and UCB Pharma, and is the director of Imaging Rheumatology BV. XB has received consulting and/or speaker’s fees and/or research grants from AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Chugai, Janssen, MSD, Novartis, Pfizer and UCB Pharma. K-GAH has received speaker’s fees for AbbVie, MSD, Pfizer and UCB Pharma. RBML has received consulting fees and/or research grants and/or speaker’s bureau from Abbott, Ablynx, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, GlaxoSmithKline, Merck, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth. PMM has received consulting/speaker’s fees from AbbVie, Centocor, Janssen, MSD, Novartis, Pfizer and UCB Pharma. WPM has received consulting and/or speaker’s fees and/or grants from AbbVie, Amgen, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi and UCB Pharma, and is the Chief Medical Officer of Canadian Research Education (CaRE) Arthritis. ORD, NdP, BH, LB and TN are employees of UCB Pharma. JB has received consulting fees/research grants from Abbott, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche and UCB Pharma.
(© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)
Comment in: Ann Rheum Dis. 2019 Aug;78(8):e84. (PMID: 29921572)
Comment in: Ann Rheum Dis. 2019 Aug;78(8):e85. (PMID: 29991474)

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