Ucb pharmaceutical company announces new 24-week data from two Phase 3 studies (Be Mobile 1 and Be Mobile 2) of bimekizumab in the treatment of active non-radiographic axial spondyloarthritis (nr-axSpa) and active ankylosing spondylitis (Sa). Both studies, presented at the European Congress of Rheumatology, (Eular 2022) – a company note reads – reached all the primary and secondary endpoints at week 16, with statistical significance, demonstrating important improvements compared to placebo at the level of disease signs and symptoms across the full spectrum of the axSpa, with consistent outcomes for patients with nr-axSpa and Sa. The safety profile of the monoclonal antibody, in both studies, was consistent with the safety data from previous studies, with no new safety signals observed.
In the same note, Ucb also announced new post-hoc analyzes, after the open-label extension of the Phase 2b study (Be Agile) – also presented at Eular – in which bimekizumab allowed to maintain clinical responses over three years in patients with active SA. Bimekizumab is not approved for administration in patients with nr-axSpa or Sa by the drug regulatory authorities.
“These results of the Be Mobile 1 and Be Mobile 2 studies today represent irrefutable evidence in support of the potential of bimekizumab, both in the case of nr-axSpa and in the case of Sa, and highlight the significant clinical results that can be achieved on the targets. -17F, as well as Il-17A “, says Atul Deodhar, professor of Arthritis and rheumatic diseases at Health & Science University in Portland (USA).” Patients with nr-axSpa and Sa – he continues – have a burden of disease which is similar and to have identified a treatment that could potentially show consistent results across the spectrum of the disease is encouraging. ”
As Désirée van der Heijde, professor of rheumatology Leiden University medical center, Leiden (The Netherlands) observes: “Patients with axSpa live with a range of debilitating symptoms, including chronic back pain and difficulty carrying out daily activities. Intermediate results from the Be Mobile 1 and Be Mobile 2 studies are encouraging, as they confirm that treatment with bimekizumab compared to placebo improved signs and symptoms, reduced disease activity and inflammation, and improved physical function. 52 weeks of these studies, expected by the end of the year “.
“We are pleased to share the first detailed data from our Phase 3 clinical program with bimekizumab for the treatment of non-radiographic axSpa and ankylosing spondylitis, confirming its clinical potential in improving patient outcomes across the full spectrum of this. debilitating disease, “said Emmanuel Caeymaex, executive vice president, Immunology solutions and Head of Us, Ucb. “People with axSpa often live with the disease for many years before diagnosis, even today with limited options for the treatment of non-radiographic axSpa. We want to propose differentiated solutions, which respond to unmet needs. These results represent an important step in our mission ”.
Axial spondyloarthritis (axSpa) – writes Ucb – including both non-radiographic axSpa and ankylosing spondylitis (Sa), also known as radiographic axSpa (r-axSpa), is a chronic, immune-mediated inflammatory disease. The nr-axSpa is clinically defined by the absence of definitive radiographic evidence of structural damage to the sacroiliac joints. AxSpa is a painful condition that primarily affects the spine and the joints that connect the pelvis and lower spine (sacroiliac joints). The main symptom of axSpa in most patients is inflammatory back pain, which improves with exercise, but not with rest. Other common clinical features often include anterior uveitis, enthesitis, peripheral arthritis, psoriasis, inflammatory bowel disease, and dactylitis. The overall prevalence of axSpa, which usually occurs before age 45, is between 0.3% and 1.3% of adults. About half of all affected patients suffer from nr-axSpa. Approximately 10-40% of nr-axSpa patients progress to ankylosing spondylitis over 2-10 years.
Bimekizumab is a humanized monoclonal Igg1 antibody designed to selectively inhibit both interleukin 17A (Il-17A) and interleukin 17F (Il-17F), two key cytokines that support inflammatory processes. The biologic is also in clinical development for the treatment of active psoriatic arthritis.