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

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.

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.

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.

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.