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Title
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Effectiveness and safety of 12-month certolizumab pegol treatment for axial spondyloarthritis in real-world clinical practice in Europe
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Author
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Abstract
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| Objectives. The efficacy and safety of certolizumab pegol (CZP), an Fc-free, PEGylated anti-TNF, in axial spondyloarthritis (axSpA) has been established in clinical trial settings. We report CZP effectiveness and safety in European clinical practice in patients with axSpA, including radiographic (r-) and non-radiographic (nr-) axSpA. Methods. CIMAX (NCT02354105), a European non-interventional multicentre prospective study, observed CZP treatment response and safety over 12 months in a real-world axSpA cohort. The primary outcome was change from baseline in BASDAI to week 52, with additional outcomes pertaining to effectiveness and safety. Patients who received >= 1 dose CZP were followed up for adverse events, and those with baseline and >= 1 post-baseline BASDAI assessment were included in effectiveness analyses. Results. A total of 672 patients (r-axSpA: 469; nr-axSpA: 201; unconfirmed diagnosis: 2) from 101 sites received >= 1 dose of CZP, of whom 564 (r-axSpA: 384; nr-axSpA: 179; unconfirmed: 1) were included in the effectiveness analyses. The mean baseline BASDAI was 6.1 in the overall axSpA population and r-axSpA and nr-axSpA subpopulations. At week 52, the mean (s.D.) change in BASDAI was -2.9 (2.3; n = 439); for r-axSpA and nr-axSpA, it was -2.9 (2.2; n =301) and -2.8 (2.4; n =137), respectively (P <0.0001 for all). Similar improvements were seen across other axSpA disease measures. In total, 37.9% (255/672) patients experienced adverse events, and 1.8% (12/672) experienced >= 1 serious adverse events. Conclusion. Improvements observed in signs and symptoms of axSpA following one year of CZP treatment in real-world clinical practice were similar to those from previous randomized clinical trials, with no new safety concerns. |
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Language
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English
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Source (journal)
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Rheumatology. - London, 1999, currens
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Publication
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London
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2021
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ISSN
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1462-0324
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DOI
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10.1093/RHEUMATOLOGY/KEAA181
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Volume/pages
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60
:1
(2021)
, p. 113-124
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ISI
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000610050100034
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Pubmed ID
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32584415
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Full text (Publisher's DOI)
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Full text (open access)
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