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

被引:19
作者
van der Horst-Bruinsma, Irene E. [1 ]
van Bentum, Rianne E. [1 ]
Verbraak, Frank D. [2 ]
Deodhar, Atul [3 ]
Rath, Thomas [4 ]
Hoepken, Bengt [5 ]
Irvin-Sellers, Oscar [6 ]
Thomas, Karen [5 ]
Bauer, Lars [5 ]
Rudwaleit, Martin [7 ,8 ]
机构
[1] Amsterdam Univ Med Ctr, Locat VU Med Ctr, Dept Rheumatol, De Boelelaan 1117, NL-1081 HV Amsterdam, Netherlands
[2] Univ Amsterdam, Dept Ophthalmol, Acad Med Ctr, Amsterdam, Netherlands
[3] Oregon Hlth & Sci Univ, Div Arthrit & Rheumat Dis, Portland, OR 97201 USA
[4] St Franziskus Hosp, Dept Opthalmol, Munster, Germany
[5] UCB Pharma, Monheim, Germany
[6] UCB Pharma, Slough, Berks, England
[7] Klinikum Bielefeld, Clin Internal Med & Rheumatol, Bielefeld, Germany
[8] Charite, Dept Gastroenterol Infectiol & Rheumatol, Berlin, Germany
关键词
axial spondyloarthritis; extra-articular manifestations; TNF inhibitor; uveitis;
D O I
10.1177/1759720X211003803
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
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页数:13
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