THU0379 REDUCTION OF ANTERIOR UVEITIS FLARES IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS FOLLOWING ONE YEAR OF TREATMENT WITH CERTOLIZUMAB PEGOL: 48-WEEK INTERIM RESULTS FROM A 96-WEEK OPEN-LABEL STUDY

Abstract

Background:Acute anterior uveitis (AAU), inflammation of the anterior uveal tract, is reported in up to 40% of patients (pts) with axial spondyloarthritis (axSpA).1AAU is associated with significant clinical burden; symptoms include blurred vision, photophobia and pain.2Previous studies have shown that TNF inhibitors (TNFi) can reduce AAU flare incidence in pts with radiographic axSpA,3-5but few have focused on pts across the full axSpA spectrum.Objectives:To analyse the impact of certolizumab pegol (CZP) treatment on AAU in pts with active radiographic and non-radiographic axSpA and a recent history of AAU.Methods:C-VIEW (NCT03020992) is an ongoing multicentre, open-label, phase 4 study. Pts had active axSpA according to the ASAS classification, 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 TNFi treatment (previous failure of ≥2 NSAIDs, biologic naïve or had failed ≤1 TNFi). Pts received CZP 400 mg at Weeks (Wks) 0/2/4, then 200 mg every two wks (Q2W) to Wk 96. The primary variable was incidence of AAU flares compared to historic rates. A pre-specified interim analysis compared AAU incidence in the 48 wks prior to CZP treatment with the 48 wks of treatment, using Poisson regression adjusted for possible within-pt correlations, with period (pre- and post-baseline) and axSpA disease duration as covariates. Incidence rates (IR) were calculated based on the number of cases/pts at risk over 48 wks. Observed data are reported.Results:Of 115 enrolled pts, 89 initiated CZP treatment; 85 completed Wk 48. Baseline characteristics are shown in the Table. The 48-wk interim analysis revealed significantly fewer AAU flares/pt during CZP treatment vs 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) substantially reduced during CZP treatment (12.4% and 2.2%). After 48 wks CZP treatment, disease activity improved substantially (mean ± SD Ankylosing Spondylitis Disease Activity Score [ASDAS]: 2.0 ± 0.9; Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]: 3.3 ± 2.1), with 31.4% pts achieving ASAS partial remission and 29.1% ASDAS major improvement. No new safety signals were identified.Table.Baseline characteristicsCZP 200 mg Q2W (N=89)Age (years), mean ± SD46.5 ± 11.2Male, n (%)56 (62.9)Racial group, n (%) Caucasian87 (97.8) Other2 (2.2)Diagnosis, n (%) Radiographic axSpA76 (85.4) Non-radiographic axSpA13 (14.6)Duration of axSpA (years), mean ± SD8.6 ± 8.4Time since onset of first uveitis flare (years), mean ± SD9.9 ± 9.0ASDAS, mean ± SD3.5 ± 0.9BASDAI, mean ± SD6.5 ± 1.5Conclusion:In this open-label study, AAU flare rate significantly reduced in axSpA pts with a history of recurrent AAU during the first 48 wks of CZP. Pts also experienced substantial improvements in axSpA disease activity.