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POS0897 (2021)
REDUCTION OF ANTERIOR UVEITIS FLARES IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS DURING CERTOLIZUMAB PEGOL TREATMENT: 96-WEEK RESULTS FROM THE C-VIEW STUDY
I. Van der Horst-Bruinsma1, R. Van Bentum1, F. Verbraak2, T. Rath3, B. Hoepken4, O. Irvin-Sellers5, T. Kumke4, L. Bauer4, M. Rudwaleit6,7
1Amsterdam University Medical Centre, Location VUmc, Department of Rheumatology, Amsterdam, Netherlands
2Academic Medical Centre, University of Amsterdam, Department of Ophthalmology, Amsterdam, Netherlands
3St Franziskus-Hospital, Department of Ophthalmology, Münster, Germany
4UCB Pharma, N/A, Monheim am Rhein, Germany
5UCB Pharma, N/A, Slough, United Kingdom
6Klinikum Bielefeld, Clinic for Internal Medicine and Rheumatology, Bielefeld, Germany
7Charité – Universitätsmedizin Berlin, Department of Gastroenterology, Infectiology and Rheumatology, Berlin, Germany

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 elsewhere 5 ). 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.

Changes in axSpA disease activity to Week 96

Disease activity measure Week 0 (n=89 ) Week 48 (n=86 ) Week 96 (n=82 )
ASAS responder rates, n (%)
ASAS20 N/A 65 (75.6) 62 (75.6)
ASAS40 N/A 46 (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


Citation: Ann Rheum Dis, volume 80, supplement 1, year 2021, page 705
Session: Spondyloarthritis – treatment (POSTERS only)