Session Type: ACR Abstract Session
Session Time: 4:30PM-6:00PM
Acute anterior uveitis (AAU), inflammation of the anterior uveal tract, is the most common extraarticular manifestation in patients (pts) with axial spondyloarthritis (axSpA), reported by up to 40% of pts.1 Uveitis is associated with a significant clinical burden; common symptoms include blurred vision, photophobia and pain.2 Previous studies have shown that anti-TNFs can reduce the incidence of AAU flares in pts with radiographic axSpA (ankylosing spondylitis),3,4,5 but few have focused on pts across the full axSpA spectrum. The aim of the C-VIEW study was to analyze the impact of certolizumab pegol (CZP) treatment on AAU flares in pts with active axSpA (radiographic and non-radiographic) and a recent history of AAU.
Methods: C-VIEW (NCT03020992) is an ongoing multicenter, open-label, phase 4 study. Pts had active axSpA according to the Assessment of SpondyloArthritis international Society (ASAS) classification criteria, a history of recurrent AAU (≥2 AAU flares in total and ≥1 AAU flare in the year prior to study entry), were HLA-B27 positive, and were eligible for anti-TNF treatment (active axSpA, previous failure of ≥2 NSAIDs, biologic naïve or had failed at most one anti-TNF). Pts received CZP 400 mg at Weeks (Wks) 0/2/4, then 200 mg every 2 wks through 96 wks. The primary variable was the incidence of AAU flares compared to historic rates. A pre-specified interim analysis compared AAU incidence in the 48 wks prior to CZP treatment initiation with the 48 wks of treatment, using Poisson regression adjusted for possible within-patient correlations, with period (pre- and post-baseline) and axSpA disease duration as covariates. Incidence rates (IR) were calculated based on the number of cases per pts at risk over 48 weeks. Observed data are reported.
Results: Of 115 enrolled pts, 89 initiated CZP treatment and 85 completed Wk 48. Baseline characteristics are shown in the Table. The 48-wk interim analysis revealed significantly fewer AAU flares per pt during CZP treatment compared to before treatment (Figure; Poisson-adjusted IR: 0.2 vs 1.5, p< 0.001). The number of pts experiencing 1 and ≥2 AAU flares (64.0% and 31.5%, respectively) was substantially reduced during CZP treatment (12.4% and 2.2%). In the 13 patients who had AAU flares both pre- and post-baseline, the mean duration of AAU flares was also reduced during CZP treatment from 97.4 to 58.4 days. After 48 wks CZP, pts’ disease activity had improved substantially (mean ± SD Ankylosing Spondylitis Disease Activity Score [ASDAS]: 2.0 ± 0.9; BASDAI: 3.3 ± 2.1), with 31.4% of pts achieving ASAS partial remission and 29.1% ASDAS major improvement. No new safety signals were identified.
In this open-label study, we found a significant reduction in the AAU flare rate in axSpA pts with a history of recurrent AAU during the first 48 wks of CZP treatment. Pts also experienced significant improvement in axSpA disease activity during CZP treatment.
1. Martin TM. Curr Opin Rheumatol 2002;14:337–41; 2. Bacchiega ABS. Rheumatology (Oxford) 2017;56:2060–7; 3. van der Heijde D. Rheumatology (Oxford) 2017;56:1498–1509; 4. van Bentum RE. J Rheumatol 2019;46:153–9; 5. van Denderen JC. J Rheumatol 2014;41:1843–8.
To cite this abstract in AMA style:van der Horst-Bruinsma I, van Bentum R, Verbraak F, Rath T, Rosenbaum J, Misterska-Skóra M, Hoepken B, Irvin-Sellers O, VanLunen B, Bauer L, Rudwaleit M. Reduction of Anterior Uveitis Flares in Patients with Axial Spondyloarthritis Following 1 Year of Treatment with Certolizumab Pegol: 48-Week Interim Results from a 96-Week Open-Label Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/reduction-of-anterior-uveitis-flares-in-patients-with-axial-spondyloarthritis-following-1-year-of-treatment-with-certolizumab-pegol-48-week-interim-results-from-a-96-week-open-label-study/. Accessed June 7, 2020.
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