Phase III and IV study data shows benefits of Cimzia in axial spondyloarthrtis.- UCB

UCB announced important new rheumatology data being presented on Cimzia (certolizumab pegol) in treating axial spondyloarthrtis. A post-hoc analysis of the 52-week data from the Phase III C-AXSPAND study of Cimzia showed that non-radiographic axial spondyloarthrtis (nr-axSpA) patients with less than five years of symptoms prior to initiation of Cimzia treatment had greater improvements across signs and symptoms of disease and quality of life, compared to patients with at least five years of symptoms prior to Cimzia treatment. These data suggest the value of diagnosing nr-axSpA patients and initiating anti-TNF treatment at an early stage of disease to help improve clinical outcomes. Nr-axSpA is a chronic inflammatory arthritis predominantly affecting the spine and sacroiliac joints, and is a distinct condition within the spondyloarthritis family of chronic inflammatory diseases. In nr-axSpA, there is no definitive radiographic sacroiliitis, though more sensitive magnetic resonance imaging (MRI) testing may detect evidence of active sacroiliitis, visible as inflammation in the sacroiliac joints.

Earlier this year, Cimzia became the first and only treatment to gain FDA approval in the U.S. for the treatment of active nr-axSpA with objective signs of inflammation. The approval was based on the C-AXSPAND study, which demonstrated a statistically significant number of patients treated with Cimzia, in addition to non-biologic background medications (NBBM), reached a Major Improvement in ASDAS (Ankylosing Spondylitis Disease Activity Score) over the 52-week trial, versus placebo plus NBBM. Interim 48-week results from a Phase IV multicenter open-label C-VIEW study will be shared in an oral presentation, showing a significant impact of Cimzia on reductions in the acute anterior uveitis flare rate in axial spondyloarthritis (axSpA) patients. C-VIEW is the first study to include a broad population of axSpA patients with active disease, HLA-B27 positivity and a documented history of acute anterior uveitis, the most common extra-articular manifestation in axSpA, affecting up to 40 percent of patients and causing a significant burden. Data were presented at the 2019 American College of Rheumatology and the Association of Rheumatology Professionals (ACR/ARP) Annual Meeting.