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. 2021 Mar 29:13:1759720X211003803.
doi: 10.1177/1759720X211003803. eCollection 2021.

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

Irene E van der Horst-Bruinsma  1 , Rianne E van Bentum  2 , Frank D Verbraak  3 , Atul Deodhar  4 , Thomas Rath  5 , Bengt Hoepken  6 , Oscar Irvin-Sellers  7 , Karen Thomas  6 , Lars Bauer  6 , Martin Rudwaleit  8
Affiliations

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

Irene E van der Horst-Bruinsma et al. Ther Adv Musculoskelet Dis. .

Abstract

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 clinicaltrialsgov: NCT03020992, URL: https://clinicaltrials.gov/ct2/show/NCT03020992.

Keywords: TNF inhibitor; axial spondyloarthritis; extra-articular manifestations; uveitis.

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Conflict of interest statement

Conflict of interest statement: Irene E. van der Horst-Bruinsma: Honoraria/consulting fees/research grants from AbbVie, BMS, MSD, Novartis, Pfizer, UCB Pharma; Rianne E. van Bentum: none; Frank D. Verbraak: Honoraria/consulting fees/research grants from Bayer, Novartis, IDxDR, UCB Pharma; Atul Deodhar: Honoraria/consulting fees/research grants from AbbVie, Amgen, Boehringer Ingelheim, BMS, Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB Pharma; Thomas Rath: Honoraria/consulting fees from AbbVie, BMS, Chugai, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma; Bengt Hoepken, Oscar Irvin-Sellers, Lars Bauer: Employees of UCB Pharma; Karen Thomas: Former contractor with UCB Pharma; Martin Rudwaleit: Honoraria/consulting fees from AbbVie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, UCB Pharma.

Figures

Figure 1.
Figure 1.
A. Percentage of patients experiencing 0, 1 or ⩾2 AAU flares. B. Mean number of AAU flares per patient. C. Poisson-adjusted AAU event rate per 96 weeks. Full analysis set (N = 89). AAU, acute anterior uveitis; CZP, certolizumab pegol; Q2W, every 2 weeks.
Figure 2.
Figure 2.
A. Mean ASDAS and B. mean BASDAI to week 96. Safety set (N = 89). Observed data are shown. ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity index; SD, standard deviation.
Figure 3.
Figure 3.
ASAS20, ASAS40 and ASAS partial remission response rates. Safety set (N = 89). Observed data are shown. ASAS, Assessment of SpondyloArthritis international Society; PR, partial remission.
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References

    1. Biggioggero M, Crotti C, Becciolini A, et al.. The management of acute anterior uveitis complicating spondyloarthritis: present and future. Biomed Res Int 2018; 2018: 9460187. - PMC - PubMed
    1. Bacchiega ABS, Balbi GGM, Ochtrop MLG, et al.. Ocular involvement in patients with spondyloarthritis. Rheumatology (Oxford) 2017; 56: 2060–2067. - PubMed
    1. Rosenbaum JT, Smith JR. Anti-TNF therapy for eye involvement in spondyloarthropathy. Clin Exp Rheumatol 2002; 20: S143–S145. - PubMed
    1. Frantz C, Portier A, Etcheto A, et al.. Acute anterior uveitis in spondyloarthritis: a monocentric study of 301 patients. Clin Exp Rheumatol 2019; 37: 26–31. - PubMed
    1. De Winter JJ, Van Mens LJ, Van Der Heijde D, et al.. Prevalence of peripheral and extra-articular disease in ankylosing spondylitis versus non-radiographic axial spondyloarthritis: a meta-analysis. Arthritis Res Ther 2016; 18: 196. - PMC - PubMed

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