#EULAR2018 – Phase 2 Trial Results Show Bimekizumab Leads to Improvements in AS Activity

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by Alice Melao |

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bimekizumab shows potential in AS

The investigative therapy bimekizumab showed significant potential in reducing disease activity and it provided clinically meaningful improvements in ankylosing spondylitis (AS) patients, according to Phase 2b clinical trial data.

UCB Pharma recently presented the trial’s findings in a study, “Dual Neutralisation of IL-17a and IL-17F with Bimekizumab in Patients with Active Ankylosing Spondylitis (AS): 12-Week Results from a Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Study,” at the 2018 Annual Congress of the European League Against Rheumatism (EULAR) in Amsterdam, the Netherlands.

Bimekizumab (also known as CDP-4940 and UCB-4940) is an engineered antibody that selectively targets and neutralizes two molecules, IL-17A and IL-17F, known to be important mediators of immune-triggered inflammatory processes.

The ongoing Phase 2b BE AGILE trial (NCT02963506) is evaluating the safety and efficacy of increasing doses of bimekizumab to treat patients with active ankylosing spondylitis.

A total of 303 patients were randomized to receive subcutaneous injections of 16 mg, 64 mg, 160 mg, or 320 mg of the antibody or a placebo every four weeks for a total of 12 weeks. All the participants had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of four or above, indicative of active disease.

To date, 98% of enrolled participants completed the 12-week treatment period, of whom 84.5% were males with a mean age of 42.2 and median symptom duration of 13.3 years.

At week 12, more patients treated with bimekizumab achieved a 40% or greater disease response, as determined by the Axial Spondyloarthritis International Society 40% response criteria (ASAS40), than those who received placebo. This was true across all tested doses.

ASAS40 criteria include four domains: patient global, pain, function, and inflammation. To meet an ASAS40 response, three of the four domains should improve by at least 40%.

A total of 58.3% of patients who were treated with 160 mg bimekizumab and 72.1% of patients who were treated with 320 mg of the therapy achieved ASAS20 improvement criteria, compared to 28.3% in the placebo group.

These criteria are identical to the ASAS40; however, to meet an ASAS20 response, three of the four domains need only improve by at least 20%.

After 12 weeks of treatment, bimekizumab also reduced BASDAI scores and levels of C-reactive protein (a biomarker of inflammation), both of which indicate a significant improvement in disease activity.

During the study the incidence of treatment-related adverse events was similar between bimekizumab and placebo, with no new safety issues reported. The most frequent adverse effects included headaches and inflammation of the throat and nose.

Based on these results, researchers believe that “dual neutralization of IL-17A and IL-17F with bimekizumab” may be a potential therapeutic option to achieve “clinically meaningful improvements in disease outcome measures.”

According to Emmanuel Caeymaex, head of immunology and executive vice president of the immunology patient value unit at UCB, the data presented exemplifies UCB’s “mission to understand the needs of underserved patient populations, and connect them with scientific advancements that can provide real and immediate impact.”

“We are committed to serving as partners in care by understanding and supporting patients and rheumatologists, who are engaging especially challenging treatment situations, so we can bring the broadest possible value to patients in need,” Caeymaex said in a press release.

In addition to ankylosing spondylitis, the investigative therapy is also being evaluated as a potential treatment for chronic plaque psoriasis and psoriatic arthritis.