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

BackgroundAcute 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.MethodsC-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.ResultsIn 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.ConclusionsThere 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.

Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study

“…Relevant improvements in patients' axSpA disease activity, according to ASDAS, BASDAI and ASAS responses, were also demonstrated in the C-VIEW study, which were in line with previous studies of CZP. 24,25,27 Moreover, CZP was well tolerated during the 96-week treatment period; no new safety signal was identified compared to previous reports 28 and only five of 89 subjects who initiated CZP discontinued the study due to adverse events, which was consistent with previous reports of CZP in axSpA. 24,25 The incidence and type of adverse events were also consistent with the known safety profile of CZP.…”

“…Further information on details recorded by treating ophthalmologists for AAU flares, both during the 2-year period prior to baseline and during the treatment period, have previously been reported. 28 …”

“…Assuming an approximate 50% reduction in AAU flares during CZP treatment, a sample size of 86 patients would provide a statistical power of 80%. 28 …”

“…Results from a 48-week interim analysis of C-VIEW data have been published previously. 28 Here, we report the final 2-year outcomes.…”

Treatment strategies in axial spondyloarthritis: what, when and how?

“…Data from the Swedish biologics registry and from a US claims database reported that adalimumab and infliximab are associated with reduced risk of acute anterior uveitis development and flares in patients with AS, compared with etanercept [ 58 , 59 ]. Data for golimumab and certolizumab are also suggestive of efficacy for uveitis in axSpA [ 60 , 61 ]. There are currently very limited data available for IL-17A and JAK inhibitors in uveitis, with secukinumab failing to meet the primary efficacy endpoints in three small linked RCTs of non-infectious uveitis [ 62 ].…”