Certolizumab pegol reduces acute anterior uveitis in axial spondyloarthritis

Results from the ongoing, multicentre, open-label, phase 4 C-VIEW trial show that certolizumab pegol significantly reduces acute anterior uveitis (AAU) flare rate and axial spondyloarthritis (axSpA) disease activity [1].

AAU is an inflammation of the anterior uveal tract characterised by blurred vision, photophobia, and pain [2]. It is reported in up to 40% of axSpA patients, which makes it the most common extra-articular manifestation in axSpA patients [3]. Previous studies have shown that TNF inhibitor (TNFi) monoclonal antibodies may reduce AAU flare incidence in patients with radiographic axSpA, but data in non-radiographic axSpA is scarce [4-6].

Prof. Irene van der Horst-Bruinsma (Amsterdam University Medical Center, the Netherlands) presented the results of the phase 4 C-VIEW trial that analysed the impact of certolizumab pegol treatment on AAU in patients with active radiographic and non-radiographic axSpA and a recent history of AAU. Eligible patients (n=115) had adult-onset axSpA with ≥3 months symptom duration, active radiographic or non-radiographic axSpA (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥4 and spinal pain ≥4), inadequate response or contraindication to ≥2 non-steroidal anti-inflammatory drugs (NSAIDs), HLA-B27 positivity, and ≥2 prior AAU flares (with at least 1 flare in the 12 months pre-baseline). Exclusion criteria were any other inflammatory arthritis and prior exposure to >1 TNFi, or primary failure/hypersensitivity to any TNFi.

Participants received certolizumab pegol 400 mg at weeks 0, 2, and 4, then 200 mg every 2 weeks to week 96. The primary variable was incidence of AAU flares compared with historic rates. A pre-specified interim analysis compared AAU incidence in the 48 weeks prior to certolizumab pegol treatment with the 48 weeks of treatment, using Poisson regression adjusted for possible within-patient correlations, with pre- and post-baseline period and axSpA disease duration as covariates. The incidence rates (IR) were calculated based on the number of cases/patients at risk over 48 weeks. Of the 115 participants, 89 initiated certolizumab pegol treatment and 85 patients completed week 48. Mean age of the patients was 46.5 years, 37.1% was female, and 97.8% was Caucasian. The percentage of radiographic axSpA was 85.4%, and 14.6% had non-radiographic axSpA. Mean time since diagnosis was 8.6 years, and mean time since onset of first uveitis flare was 9.9 years. Mean Ankylosing Spondylitis Disease Activity Score (ASDAS) was 3.5 ± 0.9, and mean BASDAI was 6.5 ± 1.5.

Results from this 48-week interim analysis showed that significantly fewer patients had AAU flares during certolizumab pegol treatment than before treatment (IR 0.2 vs 1.5; P<0.001). The number of patients experiencing 1 or ≥2 AAU flares (64.0% and 31.5% at baseline, respectively) was substantially reduced during certolizumab pegol treatment (12.4% and 2.2%, respectively). After 48 weeks of treatment, disease activity improved substantially (mean ± SD ASDAS 2.0 ± 0.9; BASDAI 3.3 ± 2.1); 31.4% of patients achieved ASDAS partial remission and 29.1% ASDAS major improvement.

The authors concluded that 48 weeks of treatment with certolizumab pegol resulted in an 87% reduction in AAU flare rate and substantial improvements in axSpA disease activity, while no new safety signals came to light. These findings suggest certolizumab pegol may be a suitable treatment option for patients with axSpA and a history of recurrent AAU.

1. Van der Horst-Bruinsma I, et al. THU0379. EULAR E-Congress, 3-6 June 2020.
2. Bacchiega ABS, et al. Rheumatology 2017;56:2060-2067.
3. Martin TM, et al. Curr Opin Rheumatol 2002;14:337-341.
4. Van der Heijde D, et al. Rheumatology 2017;56:1498-1509.
5. Van Bentum RE, et al. J Rheumatol. 2019;46:153-159.
6. Van Denderen JC, et al. J Rheumatol 2014;41:1843-1848.

Posted on 14 August 202017 May 2024