The impact of certolizumab pegol treatment on the incidence of anterior uveitis flares in patients with axial spondyloarthritis: 48-week interim results from C-VIEW

Abstract

Background: Acute anterior uveitis (AAU) is the most common extra-articular manifestation in patients with axial spondyloarthritis (axSpA). C-VIEW investigates the impact of the Fc-free TNF inhibitor certolizumab pegol (CZP) on AAU flares in patients with active axSpA at high risk of recurrent AAU.

Methods: C-VIEW (NCT03020992) is a 96-week ongoing, multicentre, open-label, phase 4 study. Included patients had an axSpA diagnosis, a history of recurrent AAU (≥2 AAU flares, ≥1 flare in the year prior to study entry), HLA-B27 positivity, active disease, and failure of ≥2 non-steroidal anti-inflammatory drugs. Patients received CZP 400 mg at Weeks 0/2/4, then 200 mg every 2 weeks up to 96 weeks. This 48-week pre-planned interim analysis compares AAU flare incidence in the 48 weeks before and after initiation of CZP treatment, using Poisson regression to account for possible within-patient correlations.

Results: In total, 89 patients were included (male: 63%; radiographic/non-radiographic axSpA: 85%/15%; mean axSpA disease duration: 8.6 years). During 48 weeks' CZP treatment, 13 (15%) patients experienced 15 AAU flares, representing an 87% reduction in AAU incidence rate (146.6 per 100 patient-years (PY) in the 48 weeks pre-baseline to 18.7 per 100 PY during CZP treatment). Poisson regression analysis showed that the incidence rate of AAU per patient reduced from 1.5 to 0.2 (p<0.001). No new safety signals were identified.

Conclusions: There was a significant reduction in the AAU flare rate during 48 weeks of CZP treatment, indicating that CZP is a suitable treatment option for patients with active axSpA and a history of recurrent AAU.

Keywords: TNF inhibitor; axial spondyloarthritis; extra-articular manifestations; uveitis.

Figure 1

(A) Mean number of AAU flares pre- and post-baseline. (B) Proportion of patients experiencing AAU flares pre- and post-baseline. Safety Set (N=89). Four patients had an AAU flare in the 12 months prior to baseline but not during the 48-week pretreatment period. AAU, acute anterior uveitis; CZP, certolizumab pegol; Q2W, every 2 weeks.

Figure 2

Mean (A) ASDAS and (B) BASDAI up to Week 48. Safety Set (N=89). Observed data are shown. ASDAS, Ankylosing Spondylitis Disease Activity Score; AU, anterior uveitis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; CZP, certolizumab pegol; Q2W, every 2 weeks.

Figure 3

(A) ASAS20, ASAS40 and ASAS partial remission responder rates up to Week 48 in axSpA patients receiving CZP 200 mg Q2W and (B) ASDAS, CII, MI, and ID responder rates up to Week 48 in axSpA patients receiving CZP 200 mg Q2W. Safety Set (N=89). Observed data are shown; total number of patients assessed at each timepoint is shown. ASAS, Assessment of SpondyloArthritis international Society; ASAS20/40, ASAS 20%/40% response; axSpA, axial spondyloarthritis; CII, clinical important improvement; CZP, certolizumab pegol; ID, inactive disease; MI, major improvement; PR, partial remission; Q2W, every 2 weeks.