Bimekizumab Can Improve Outcomes of AS Patients, Phase 2b Trial Finds

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by Alice Melao |

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Inhibiting both IL-17A and IL-17F signaling molecules with the investigational antibody bimekizumab can effectively improve the outcomes of patients with ankylosing spondylitis, according to clinical results.

The study, “Dual Neutralisation of Il-17A and Il-17F with Bimekizumab Was Associated with Improvements in Patient-Reported and Quality-Of-Life Outcomes in Patients with Active Ankylosing Spondylitis: Results from a Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Study,” was recently presented during the 2019 Annual European Congress of Rheumatology (EULAR) in Madrid, Spain.

Bimekizumab, formerly known as UCB-4940, is a new humanized antibody being developed by UCB to selectively block the activity of IL-17A and IL-17F pro-inflammatory cytokines (small signaling proteins). These two signaling molecules have similar biological activity and can cooperate with other pro-inflammatory mediators to drive chronic inflammation and damage across tissues.

Preclinical studies have shown that neutralizing these two cytokines at the same time can reduce skin and joint inflammation, and prevent abnormal bone formation to a greater extent than the inhibition of IL-17A alone.

Researchers conducted a Phase 2b trial (NCT02963506) to explore the therapeutic activity of bimekizumab in patients with ankylosing spondylitis.

The trial enrolled 303 patients with active disease, as determined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of four or higher. Participants were randomized to receive subcutaneous (under the skin) injections every four weeks of increasing doses of bimekizumab or a non-active placebo.

Upon completion of 12 weeks of treatment, approximately 23.7–47.5% of bimekizumab-treated patients achieved at least a 50% improvement in key symptoms, including pain, fatigue, morning stiffness, and function, compared to placebo (11.9% ).

All bimekizumab tested doses were associated with greater reductions in individual BASDAI components. These included reductions of up to 3.1-fold in fatigue, 2.75-fold in neck, back, or hip pain, 2.73-fold in discomfort due to tenderness to touch or pressure, 2.92-fold in level of morning stiffness, and a reduction of up to 2.36-fold in duration of morning stiffness compared to placebo.

Treatment with bimekizumab also improved patients’ ability to be active, as shown by a 3.67-fold reduction of Bath Ankylosing Spondylitis Functional Index (BASFI) scores, which assess the degree of functional limitation in patients with ankylosing spondylitis.

Overall, bimekizumab was shown to improve patients’ health-related quality of life regardless of the dose administrated.

During the study, the incidence of treatment-related adverse events was similar between bimekizumab and placebo, with the majority being mild or moderate. The most commonly reported side effects were inflammation of the throat and nose and a headache.

These data suggest that “bimekizumab may deliver results that improve disease activity and outcomes that are most important from the patient perspective, like pain, fatigue, stiffness, mobility, and function,” Emmanuel Caeymaex, head of immunology and executive vice president of immunology patient value unit at UCB, said in a press release.

The potential of bimekizumab for ankylosing spondylitis, non-radiographic axial spondyloarthritis, psoriatic arthritis, and psoriasis is now being evaluated in Phase 3 trials, including BE MOBILE 2 (NCT03928743), which is currently recruiting up to 300 adults with moderate to severe active ankylosing spondylitis who do not respond to or cannot be treated with non-steroidal anti-inflammatory drugs (NSAIDs).

Find more information about trial locations and contacts here.