Bimekizumab Found to be Safe and Show Sustained Efficacy for AS Treatment in Phase 2b Trial

Treatment with the experimental therapy bimekizumab is safe and shows sustained efficacy over 48 weeks in people with ankylosing spondylitis (AS), data from a Phase 2b trial show.

In addition, the use of biologic therapies for AS is associated with more comorbidities and higher use of other treatments in women than in men, according to bimekizumab’s developer UCB, which presented the findings at the 2019 American College of Rheumatology and the Association of Rheumatology Professionals Annual Meeting, in Atlanta Nov. 8–13.

The bimekizumab research, “Dual Neutralization of IL-17A and IL-17F with Bimekizumab in Patients with Active Ankylosing Spondylitis: 48-Week Efficacy and Safety Results From a Phase 2b, Randomized, Blinded, Placebo-Controlled, Dose-Ranging Study,” detailed results from a Phase 2b clinical trial (NCT02963506) of the investigational treatment in people with AS.

Bimekizumab is an antibody that blocks the activity of interleukin (IL)-17A and IL-17F, two proteins that drive inflammation in AS.

In the UCB-funded trial, 303 people with AS were treated with one of four doses of bimekizumab (16, 64, 160, or 320 mg) or a placebo every four weeks for 12 weeks. Then, participants on the two lower doses of the therapy or on the placebo were randomly assigned to one of the two higher doses for an additional 36 weeks.

The study’s main efficacy endpoints, or goals, were measured using benchmarks from the Assessment in SpondyloArthritis International Society (ASAS).

Of 303 patients initially enrolled, 265 (87.5%) completed the 48-week treatment period. These participants were predominantly male (84.5%), their mean age was 42.2 years, and they had symptoms over a median of 12.3 years. Baseline characteristics, including the use of TNF inhibitors, were similar across all groups.

In general, improvements seen at 12 weeks were sustained up to 48 weeks of treatment. The percentage of participants who achieved 40% response based on ASAS (ASAS40) ranged from 35.5%–64.0%, with generally higher rates among those on higher dosages. The percentage achieving ASAS partial remission ranged from 20.6%–34.4%.

Of note, ASAS40 means that patients need to show improvement/reduction of at least 40% in a minimum of three out of four domains: patient global assessment of disease, pain, function, and inflammation.

Treatment with bimekizumab was generally well-tolerated, with no unexpected safety findings. Over 48 weeks, 235 (77.6%) participants experienced at least one adverse event (AE), 110 (36.3%) of which were deemed related to bimekizumab. The most common AE was inflammation in the nose and throat, or nasopharyngitis. Twenty (6.6%) AEs led to treatment discontinuation.

“Following positive results at Week 12, this Phase 2b study demonstrated the sustained efficacy of bimekizumab in [patients] with active AS to Week 48,” the researchers wrote.

Researchers at UCB also analyzed insurance claims made by people with AS in the United States between 2012 and 2017 in another study, “Gender Differences in Comorbidities and Treatment Utilization among Ankylosing Spondylitis Patients Initiating a Biologic in a Real-World Setting.”

They specifically looked at real-world data on the use of biologic therapies based on gender in 1,526 AS patients (668 women and 858 men) with at least one year of data. The most commonly used treatments were Humira (adalimumab) by 52% of patients and Enbrel (etanercept) by 31%.

At baseline, significantly more women than men had insurance claims related to anxiety (17% women vs. 8% men), depression (23% vs. 10%), fatigue (29% vs. 21%), and fibromyalgia (16% vs. 6%), as well as for opioids (59% vs 50%) or non-steroidal anti-inflammatory drugs (72% vs 67%). These trends in medication use persisted over the course of one year.

In addition, more men (55%) than women (43%) continued to use a biologic one year after beginning treatment. Women were less likely to be treated with a biologic after this period (71% vs 78%).

“The comorbidity and treatment exposures depict a more complex profile for women vs. men, which may be important to consider when determining the best approach to disease management,” the team wrote.

UCB also presented data on investigational treatments for other diseases, including dapirolizumab pegol for lupus, Cimzia (certolizumab pegol) for axial spondyloarthrtis (axSpA), and bimekizumab in psoriatic arthritis (PA).

“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,” Emmanuel Caeymaex, UCB’s head of immunology and executive vice president of immunology solutions, said in a press release.

“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,” he added.