• Oral presentations include data on improvements in clinical and patient-reported outcomes with early CIMZIA (certolizumab pegol) treatment in non-radiographic axial spondyloarthritis, and a reduction in anterior uveitis flares in axial spondyloarthritis patients following one year of treatment with CIMZIA • Oral presentations of new 48-week data from Phase 2b trials of investigational molecule bimekizumab support the potential value of dual neutralization of IL-17A and IL-17F in psoriatic arthritis and ankylosing spondylitis • Oral presentation of data from the Phase 2b trial of investigational molecule dapirolizumab pegol in patients with moderately to severely active systemic lupus erythematosus
Brussels, Belgium – 08 November 2019 – UCB, a global biopharmaceutical company, today announced important new rheumatology data being presented on CIMZIA® (certolizumab pegol) and investigational molecules bimekizumab and dapirolizumab pegol at the 2019 American College of Rheumatology and the Association of Rheumatology Professionals (ACR/ARP) Annual Meeting in Atlanta, on November 8-13.
“UCB research presented at the 2019 ACR/ARP congress reflects our leadership in addressing unmet patient needs and providing treatment options that could make a meaningful difference for people living with axSpA, PsA and lupus. The breadth and depth of UCB’s 13 data presentations are intended to improve our understanding of how best to address these serious diseases, which can profoundly impact patients’ lives. UCB continues to deliver on its Patient Value Strategy to connect the unmet needs of patients with innovative science,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President, Immunology Solutions, UCB.
A post-hoc analysis of the 52-week data from the Phase 3 C-AXSPAND study of CIMZIA will be shared in an oral presentation. The analysis 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 4 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.
Additional presentations focus on patient-reported outcomes for axSpA patients treated with CIMZIA. Positive C-AXSPAND study results show substantial improvements in sleep quality and other clinical outcomes that are important to patients, such as stiffness and fatigue.New research on the impact of treatment with CIMZIA on improvements in work and household productivity as well as social participation for patients with nr-axSpA will be presented. Additional data from the RAPID-axSpA study showing that CIMZIA treatment in axSpA patients was associated with rapid and sustained reduction in active inflammation, no increase in sclerosis and erosions, and a negligible increase in fatty lesions in the vertebral edges of the spine also will be presented.
The RAPID-PsA study on CIMZIA in psoriatic arthritis (PsA) evaluated the relationship between PsA disease activity and structural progression over 216 weeks of treatment with CIMZIA. The study showed that it is important for patients to achieve remission or low disease activity to prevent long-term structural damage, particularly in patients at risk of radiographic progression.
An oral presentation will share efficacy and safety data from the Phase 2b clinical trial of the investigational molecule, dapirolizumab pegol, in patients with moderately to severely active systemic lupus erythematosus (SLE). The primary objective of the study was to establish a dose-response relationship for dapirolizumab pegol using pre-specified models. The study demonstrated consistent and potentially meaningful improvements for the majority of clinical endpoints in patients treated with dapirolizumab pegol compared with placebo. None of the pre-specified dose-response models could be selected; thus, the primary endpoint was not met. Dapirolizumab pegol demonstrated an acceptable safety profile. UCB and Biogen are collaborating on the development and commercialization of dapirolizumab pegol and have initiated preparations for a Phase 3 program in patients with active SLE despite standard-of-care treatment.
In addition, the company will share 48-week results from the Phase 2b dose finding studies of its investigational pipeline molecule, bimekizumab, in PsA and ankylosing spondylitis (AS) in separate oral presentations. The studies showed that treatment with bimekizumab resulted in achievement of low and/or minimal disease activity in patients with PsA, which were maintained to week 48 as well as sustained improvement in patients with active AS. The AS study showed that significantly more bimekizumab-treated patients achieved ASAS40 (Assessment of SpondyloArthritis International Society 40 percent response) at week 12, compared to placebo, and that these results were sustained to week 48 in the majority of patients. The safety profile was consistent with previous Phase 2 studies, with no new safety findings observed.
The safety and efficacy of bimekizumab and dapirolizumab pegol have not been established, and they are not approved by any regulatory authority worldwide.
UCB also will be sponsoring a symposium featuring a panel of experts discussing the challenges in recognizing, diagnosing and managing nr-axSpA. A full list of UCB-sponsored data can be found below.