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

Certolizumab Pegol Treatment in Patients with Axial-Spondyloarthritis-Associated Acute Anterior Uveitis: a Narrative Review

“…Baseline characteristics for patients included in the phase 3/4 clinical studies are provided in Table 2. These studies confirmed the safety and efficacy profile of CZP in both r-axSpA and nr-axSpA populations; data pertaining to the treatment of axial symptoms in axSpA are reported in the original publications [21][22][23][24][25][26][27].…”

“…Across all studies, CZP led to a reduction in the number of patients reporting AAU flares compared with placebo or the pretreatment period [27]. Data pertaining to AAU flare event rate have also been reported [24,25]. In C-VIEW, the adjusted event rate was 1.87 in the pretreatment period compared with 0.34 in the 96-week treatment period (Fig.…”

“…Data in this review have been obtained from one phase 4 and three phase 3 industry-supported, interventional, clinical studies that assessed CZP in axSpA-associated AAU as primary, secondary, or post-hoc outcomes: C-VIEW (NCT03020992), C-axSpAnd (NCT02552212), C-OPTIMISE (NCT02505542), and RAPID-axSpA (NCT01087762, Table 1). Detailed study design and methods have been described previously-data included in this review include both data taken from the original study publications, and data on file [19,[21][22][23][24][25][26][27].…”

“…Patients were requested to contact their ophthalmologist when they suspected an AAU flare at any time during the study. Patients received CZP 400 mg at weeks 0, 2, and 4, then 200 mg every 2 weeks to week 96 [24,25].…”

“…Certolizumab pegol (CZP) is a PEGylated Fcfree TNFi, indicated for the treatment of adult patients with active axSpA by several regulatory authorities, and is the only FDA-approved TNFi for both r-axSpA and nr-axSpA [19,20]. Previous studies have shown CZP to be safe and efficacious for axial symptoms of axSpA; with these studies comes a growing body of evidence describing the impact of CZP on the incidence of axSpA-associated AAU [21][22][23][24][25][26][27].…”