TY - JOUR
T1 - Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment
T2 - final 2-year results from the multicenter phase IV C-VIEW study
AU - van der Horst-Bruinsma, Irene E.
AU - van Bentum, Rianne E.
AU - Verbraak, Frank D.
AU - Deodhar, Atul
AU - Rath, Thomas
AU - Hoepken, Bengt
AU - Irvin-Sellers, Oscar
AU - Thomas, Karen
AU - Bauer, Lars
AU - Rudwaleit, Martin
N1 - Funding Information:
The authors thank the patients, the investigators and their teams who took part in this study. The authors also acknowledge Theresa Rosario-Jansen, UCB Pharma, USA, for critical revision and Simone E. Auteri, UCB Pharma, Belgium for critical revision and publication coordination, as well as Abbie Rogers and Jessica Patel, from Costello Medical, UK, for medical writing and editorial assistance based on the authors’ input and direction. This study was funded by UCB Pharma.
Funding Information:
The authors thank the patients, the investigators and their teams who took part in this study. The authors also acknowledge Theresa Rosario-Jansen, UCB Pharma, USA, for critical revision and Simone E. Auteri, UCB Pharma, Belgium for critical revision and publication coordination, as well as Abbie Rogers and Jessica Patel, from Costello Medical, UK, for medical writing and editorial assistance based on the authors? input and direction. This study was funded by UCB Pharma. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was sponsored by UCB Pharma. This article was based on the original study AS0007/C-VIEW (NCT03020992) sponsored by UCB Pharma. Support for third-party writing assistance for this article, provided by Abbie Rogers and Jessica Patel, Costello Medical, UK, was funded by UCB Pharma in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).
Publisher Copyright:
© The Author(s), 2021.
PY - 2021
Y1 - 2021
N2 - 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-Journals-Accessible-Video-Player10.1177/1759720X211003803.M1sj-vid-1-tab-10.1177_1759720X211003803
AB - 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-Journals-Accessible-Video-Player10.1177/1759720X211003803.M1sj-vid-1-tab-10.1177_1759720X211003803
KW - TNF inhibitor
KW - axial spondyloarthritis
KW - extra-articular manifestations
KW - uveitis
UR - http://www.scopus.com/inward/record.url?scp=85103417488&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85103417488&partnerID=8YFLogxK
U2 - 10.1177/1759720X211003803
DO - 10.1177/1759720X211003803
M3 - Article
AN - SCOPUS:85103417488
SN - 1759-720X
VL - 13
JO - Therapeutic Advances in Musculoskeletal Disease
JF - Therapeutic Advances in Musculoskeletal Disease
ER -