Effectiveness and Safety of Certolizumab Pegol in Axial Spondyloarthritis in a Real-World Setting in Greece: A Sub-Analysis of the Prospective Non-Interventional CIMAX Cohort Study.

Abstract

Objectives:We report the effectiveness and safety of certolizumab pegol (CZP) treatment in a real-world Greek axial spondyloarthritis (axSpA) population, including patients with radiographic (r-axSpA) and non-radiographic (nr-axSpA) disease.Methods:We performed a sub-analysis of the Greek cohort from CIMAX (NCT02354105), a multicentre, non-interventional cohort study that prospectively investigated CZP treatment in patients with axSpA. The primary outcome was change from baseline (CfB) in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 52.Results:Across 12 sites in Greece, 126 patients (r-axSpA: 91; nr-axSpA: 35) received ≥1 dose of CZP and were included in the Safety Set (SS), with 120 patients (r-axSpA: 86; nr-axSpA: 34) included in the Full Analysis Set (FAS). The mean (standard deviation [SD]) CfB in BASDAI at Week 52 was −3.8 (2.0) in the overall axSpA population, with numerically greater improvements observed for nr-axSpA patients compared with r-axSpA (nr-axSpA: −4.2 [2.1]; r-axSpA: −3.7 [2.0]). Improvements in the axSpA population, including r-axSpA and nr-axSpA subpopulations, were observed in key secondary and additional outcomes at Week 52. Overall, 14.3% (18/126) of patients in the axSpA population experienced ≥1 adverse event (AE). There were no serious AEs or deaths reported during the study.Conclusions:Patients with r-axSpA and nr-axSpA treated with CZP in clinical practice in Greece showed improvements in disease activity and key symptoms. CZP treatment may therefore help address the substantial health burden associated with axSpA in Greece.