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.References:[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;56:1498–509[4]van Bentum RE. J Rheumatol 2019;46:153–9[5]van Denderen JC. J Rheumatol 2014;41:1843–8Acknowledgments:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Irene van der Horst-Bruinsma Grant/research support from: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Consultant of: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Rianne van Bentum: None declared, Frank Verbraak Grant/research support from: Bayer, Novartis, IDxDR, UCB Pharma, Consultant of: Bayer, Novartis, IDxDR, UCB Pharma, Thomas Rath Grant/research support from: AbbVie, Bristol-Myers Squibb, Chugai, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, James Rosenbaum Consultant of: AbbVie, Corvus, Eyevensys, Gilead, Novartis, Janssen, Roche, UCB Pharma; royalties from UpToDate, Maria Misterska-Skora: None declared, Bengt Hoepken Employee of: UCB Pharma, Oscar Irvin-Sellers Employee of: UCB Pharma, Brenda VanLunen Employee of: UCB Pharma, Lars Bauer Employee of: UCB Pharma, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma

Uveitis in spondyloarthritis

“…119,120 Initial results of the still-ongoing, open-label phase IV C-VIEW trial were recently presented, which included 115 SpA patients with recurrent AAU. 121 Patients experienced a significant reduction of AAU flare rate under certolizumab in the interim analysis after 48 weeks (64% before versus 12% under certolizumab treatment), and AAU flares were shorter under TNFi. 121 Infliximab is the only TNFi which is intravenously administered.…”

“…121 Patients experienced a significant reduction of AAU flare rate under certolizumab in the interim analysis after 48 weeks (64% before versus 12% under certolizumab treatment), and AAU flares were shorter under TNFi. 121 Infliximab is the only TNFi which is intravenously administered. Uveitis flares were reduced in AS patients under infliximab compared with placebo (13 AAU flares per 100 patient-years versus 37).…”

“…121 Patients experienced a significant reduction of AAU flare rate under certolizumab in the interim analysis after 48 weeks (64% before versus 12% under certolizumab treatment), and AAU flares were shorter under TNFi. 121…”