The Impact of Certolizumab Pegol Treatment on the Incidence of Anterior Uveitis Flares in Patients with Axial Spondyloarthritis: Responses by Gender

Abstract

Purpose : Acute anterior uveitis (AAU) is the most common extra-articular manifestation in patients (pts) with axial spondyloarthritis (axSpA). Male pts have been shown to be more likely to develop AAU than female pts; however, data from interventional studies on AAU in axSpA comparing response to treatment by gender are scarce.¹ Here, we report the impact of CZP treatment on AAU by gender in pts with active axSpA and a history of AAU from the C-VIEW study.

Methods : C-VIEW (NCT03020992) is an ongoing multicenter, open-label, phase 4 study. Pts had active axSpA, a history of recurrent AAU (≥2 AAU flares in total and ≥1 AAU flare in the year prior to study entry), and were HLA-B27 positive. Pts received CZP 400 mg at Weeks (Wks) 0/2/4, then 200 mg every 2 wks through 96 wks. A pre-specified interim analysis compared AAU incidence in the 48 wks prior to CZP treatment initiation with the 48 wks of treatment, using Poisson regression adjusted for possible within-patient correlations, with period (pre- and post-baseline) and axSpA disease duration as covariates. Incidence rates (IR) were calculated based on the number of cases per pt at risk over 48 wks. Outcomes by gender were analyzed post-hoc. Observed case data are reported; all p-values are nominal.

Results : Of 89 pts enrolled into the study, 56 were male and 33 were female; 85 pts completed treatment to Wk48. In the 48-wk pre-baseline period, the mean ± standard deviation (SD) number of AAU flares per pt was similar between male (1.3 ± 0.6) and female pts (1.4 ± 0.8). During 48 wks’ CZP treatment, the mean number of flares reduced in both groups to 0.2 ± 0.5 and 0.2 ± 0.4, respectively; using Poisson regression analysis, this represented a decrease in incidence from 1.5 to 0.2 in male pts (p<0.001), and 1.6 to 0.2 in female pts (p<0.001; Table). AAU flare incidence per 100 patient-years (PY) decreased from 145.6 to 17.7 per 100 PY in male pts, and from 148.2 to 20.5 per 100 PY in female pts (representing reductions of 88% and 86%, respectively).

Conclusions : CZP treatment led to a significant reduction in AAU flares in both male and female pts with axSpA and a history of recurrent AAU. Improvements in AAU incidence were similar between male and female pts.

References: 1. Smith WM. J Ophthalmol 2013;2013:928264.

This is a 2020 ARVO Annual Meeting abstract.

 

Impact of 48-week CZP treatment on AAU by gender