POS0897 REDUCTION OF ANTERIOR UVEITIS FLARES IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS DURING CERTOLIZUMAB PEGOL TREATMENT: 96-WEEK RESULTS FROM THE C-VIEW STUDY
Authors: Van der Horst-Bruinsma I. , Van Bentum R. , Verbraak F. , Rath T. , Hoepken B. , Irvin-Sellers O. , Kumke T. , Bauer L. , Rudwaleit M. 
Published: May 2021

Background:

Acute anterior uveitis (AAU) is the most common extra-articular manifestation in axial spondyloarthritis (axSpA), affecting up to 40% of patients and causing significant burden.1 Previous studies have shown that tumour necrosis factor inhibitors (TNFi) can reduce the incidence of AAU flares in patients with radiographic axSpA (ankylosing spondylitis),2-4 but few have focused on patients across the full axSpA spectrum.1

Objectives:

To report 2-year outcomes from the phase 4, open-label C-VIEW study (NCT03020992), which investigated the impact of certolizumab pegol (CZP) treatment on AAU in patients with active axSpA and a recent history of AAU.

Methods:

C-VIEW prospectively investigated patients with active axSpA who were HLA-B27 positive and had recurrent AAU, with a history of ≥1 AAU flare in the year prior to baseline (additional study criteria and study design are described elsewhere5). The primary efficacy variable was the incidence of AAU flares during 96 weeks of CZP treatment versus the 2-year pre-baseline period. AAU incidence was evaluated using Poisson regression adjusted for duration of time in each period, with period (pre- and post-baseline) and axSpA disease duration as covariates. Secondary efficacy variables were Assessment of SpondyloArthritis international Society 20%/40% (ASAS20/40) response rates, as well as mean Ankylosing Spondylitis Disease Activity Score (ASDAS) and mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 96.

Results:

Of 115 enrolled patients, 89 initiated CZP treatment; 83 completed Week 96. The primary analysis revealed an 82% reduction in the incidence of AAU flares during CZP treatment compared with pre-baseline (Figure 1A; rate ratio [95% CI]: 0.18 [0.12, 0.28], p<0.001). The percentage of patients experiencing ≥1 and ≥2 AAU flares reduced from 100% and 59.6% pre-baseline to 20.2% and 11.2% during treatment (Figure 1B). There were also improvements in axSpA disease activity (Table 1): by Week 96, 75.6% and 58.5% of patients had achieved ASAS20 and ASAS40 responses, respectively. ASDAS and BASDAI also improved substantially over the 96-week treatment period. No new safety signal was identified, compared to previous reports.5

Conclusion:

These data support the use of CZP for the treatment of patients with axSpA and a history of recurrent AAU. During 96 weeks’ CZP treatment, there was a significant reduction of 82% in the AAU flare rate compared to pre-baseline. There were also substantial improvements in patients’ axSpA disease activity.

References:

[1]Martin TM. Curr Opin Rheumatol 2002;14:337–41.

[2]van der Heijde D. Rheumatology (Oxford) 2017;56:1498–509.

[3]van Bentum RE. J Rheumatol 2019;46:153–9.

[4]van Denderen JC. J Rheumatol 2014;41:1843–8.

[5]van der Horst-Bruinsma I. RMD Open 2020;6:e001161.

Table 1.

Changes in axSpA disease activity to Week 96

Disease activity measureWeek 0
(n=89)Week 48
(n=86)Week 96
(n=82)ASAS responder rates, n (%)ASAS20N/A65 (75.6)62 (75.6)ASAS40N/A46 (53.5)48 (58.5)ASDAS, mean (SD)3.5 (1.0)2.0 (0.9)1.9 (1.0)BASDAI, mean (SD)6.5 (1.5)3.3 (2.1)3.0 (2.1)

Observed data are shown. Patients received CZP 400 mg at Weeks 0/2/4, then 200 mg Q2W through 96 weeks. ASAS20/40: Assessment of SpondyloArthritis international Society 20%/40%; ASDAS: Ankylosing Spondylitis Disease Activity Score; axSpA: axial spondyloarthritis; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; CZP: certolizumab pegol; Q2W: every 2 weeks; SD: standard deviation.

Acknowledgements:

This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.

Disclosure of Interests:

Irene van der Horst-Bruinsma Speakers bureau: AbbVie, BMS, MSD, Pfizer, UCB Pharma, Consultant of: AbbVie, Eli Lilly, MSD, Novartis, UCB Pharma, Grant/research support from: AbbVie, MSD, Pfizer, Rianne van Bentum: None declared, Frank Verbraak Speakers bureau: Bayer, IDxDR, Novartis, UMC, Consultant of: Bayer, Novartis, Grant/research support from: Bayer, Thomas Rath Speakers bureau: AbbVie, BMS, Chugai, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Consultant of: AbbVie, BMS, Chugai, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Bengt Hoepken Shareholder of: UBC Pharma, Employee of: UCB Pharma, Oscar Irvin-Sellers Shareholder of: UCB Pharma, Employee of: UCB Pharma, Thomas Kumke Shareholder of: UCB Pharma, Employee of: UCB Pharma, Lars Bauer Shareholder of: UCB Pharma, Employee of: UCB Pharma, Martin Rudwaleit Speakers bureau: AbbVie, Eli Lilly, Novartis, UCB Pharma, Consultant of: AbbVie, Celgene, Eli Lilly, Janssen, Novartis, UCB Pharma