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Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study
INTRODUCTION: Acute anterior uveitis (AAU), affecting up to 40% of patients with axial spondyloarthritis (axSpA), risks permanent visual deficits if not adequately treated. We report 2-year results from C-VIEW, the first study to prospectively investigate certolizumab pegol (CZP) on AAU in patients...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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SAGE Publications
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8010825/ https://www.ncbi.nlm.nih.gov/pubmed/33854572 http://dx.doi.org/10.1177/1759720X211003803 |
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author | van der Horst-Bruinsma, Irene E. van Bentum, Rianne E. Verbraak, Frank D. Deodhar, Atul Rath, Thomas Hoepken, Bengt Irvin-Sellers, Oscar Thomas, Karen Bauer, Lars Rudwaleit, Martin |
author_facet | van der Horst-Bruinsma, Irene E. van Bentum, Rianne E. Verbraak, Frank D. Deodhar, Atul Rath, Thomas Hoepken, Bengt Irvin-Sellers, Oscar Thomas, Karen Bauer, Lars Rudwaleit, Martin |
author_sort | van der Horst-Bruinsma, Irene E. |
collection | PubMed |
description | INTRODUCTION: Acute anterior uveitis (AAU), affecting up to 40% of patients with axial spondyloarthritis (axSpA), risks permanent visual deficits if not adequately treated. We report 2-year results from C-VIEW, the first study to prospectively investigate certolizumab pegol (CZP) on AAU in patients with active axSpA at high risk of recurrent AAU. PATIENTS AND METHODS: C-VIEW (NCT03020992) was a 104-week (96 weeks plus 8-week safety follow-up), open-label, multicenter study. Eligible patients had active axSpA, human leukocyte antigen-B27 (HLA-B27) positivity and a history of recurrent AAU (⩾2 AAU flares in total; ⩾1 in the year prior to baseline). Patients received CZP 400 mg at weeks 0, 2 and 4, then 200 mg every 2 weeks to week 96. The primary efficacy endpoint was the AAU flare event rate during 96 weeks’ CZP versus 2 years pre-baseline. RESULTS: Of 115 enrolled patients, 89 initiated CZP (male: 63%; radiographic/non-radiographic axSpA: 85%/15%; mean disease duration: 9.1 years); 83 completed week 96. There was a significant 82% reduction in AAU flare event rate during CZP versus pre-baseline [rate ratio (95% confidence interval): 0.18 (0.12–0.28), p < 0.001]. One hundred percent and 59.6% of patients experienced ⩾1 and ⩾2 AAU flares pre-baseline, respectively, compared to 20.2% and 11.2% during treatment. Age, sex and axSpA population subgroup analyses were consistent with the primary analysis. There were substantial improvements in axSpA disease activity with no new safety signal identified. CONCLUSION: CZP treatment significantly reduced AAU flare event rate in patients with axSpA and a history of AAU, indicating CZP is a suitable treatment option for patients at risk of recurrent AAU. TRIAL REGISTRATION CLINICALTRIALS.GOV: NCT03020992, URL: https://clinicaltrials.gov/ct2/show/NCT03020992 |
format | Online Article Text |
id | pubmed-8010825 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-80108252021-04-13 Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study van der Horst-Bruinsma, Irene E. van Bentum, Rianne E. Verbraak, Frank D. Deodhar, Atul Rath, Thomas Hoepken, Bengt Irvin-Sellers, Oscar Thomas, Karen Bauer, Lars Rudwaleit, Martin Ther Adv Musculoskelet Dis Extra-articular manifestations and comorbidities in spon INTRODUCTION: Acute anterior uveitis (AAU), affecting up to 40% of patients with axial spondyloarthritis (axSpA), risks permanent visual deficits if not adequately treated. We report 2-year results from C-VIEW, the first study to prospectively investigate certolizumab pegol (CZP) on AAU in patients with active axSpA at high risk of recurrent AAU. PATIENTS AND METHODS: C-VIEW (NCT03020992) was a 104-week (96 weeks plus 8-week safety follow-up), open-label, multicenter study. Eligible patients had active axSpA, human leukocyte antigen-B27 (HLA-B27) positivity and a history of recurrent AAU (⩾2 AAU flares in total; ⩾1 in the year prior to baseline). Patients received CZP 400 mg at weeks 0, 2 and 4, then 200 mg every 2 weeks to week 96. The primary efficacy endpoint was the AAU flare event rate during 96 weeks’ CZP versus 2 years pre-baseline. RESULTS: Of 115 enrolled patients, 89 initiated CZP (male: 63%; radiographic/non-radiographic axSpA: 85%/15%; mean disease duration: 9.1 years); 83 completed week 96. There was a significant 82% reduction in AAU flare event rate during CZP versus pre-baseline [rate ratio (95% confidence interval): 0.18 (0.12–0.28), p < 0.001]. One hundred percent and 59.6% of patients experienced ⩾1 and ⩾2 AAU flares pre-baseline, respectively, compared to 20.2% and 11.2% during treatment. Age, sex and axSpA population subgroup analyses were consistent with the primary analysis. There were substantial improvements in axSpA disease activity with no new safety signal identified. CONCLUSION: CZP treatment significantly reduced AAU flare event rate in patients with axSpA and a history of AAU, indicating CZP is a suitable treatment option for patients at risk of recurrent AAU. TRIAL REGISTRATION CLINICALTRIALS.GOV: NCT03020992, URL: https://clinicaltrials.gov/ct2/show/NCT03020992 SAGE Publications 2021-03-29 /pmc/articles/PMC8010825/ /pubmed/33854572 http://dx.doi.org/10.1177/1759720X211003803 Text en © The Author(s), 2021 https://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Extra-articular manifestations and comorbidities in spon van der Horst-Bruinsma, Irene E. van Bentum, Rianne E. Verbraak, Frank D. Deodhar, Atul Rath, Thomas Hoepken, Bengt Irvin-Sellers, Oscar Thomas, Karen Bauer, Lars Rudwaleit, Martin Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study |
title | Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study |
title_full | Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study |
title_fullStr | Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study |
title_full_unstemmed | Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study |
title_short | Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study |
title_sort | reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase iv c-view study |
topic | Extra-articular manifestations and comorbidities in spon |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8010825/ https://www.ncbi.nlm.nih.gov/pubmed/33854572 http://dx.doi.org/10.1177/1759720X211003803 |
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