Bimekizumab shows benefits in treating axSpA at 1 year in trials

2 studies show therapy safe, effective in inflammatory arthritis patients

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by Andrea Lobo |

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A year of treatment with bimekizumab was safe and significantly eased symptoms of axial spondyloarthritis (axSpA) in participants from two Phase 3 clinical trials, data show.

“Results at [one year] from the BE MOBILE trials suggest that [bimekizumab] is an effective treatment option resulting in sustained efficacy across the full disease spectrum of axSpA,” the researchers wrote.

The study, “Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies,” was published in the journal Annals of the Rheumatic Diseases.

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Bimekizumab Leads to Rapid Clinical Improvements in Phase 3 Trials

BE MOBILE trials tested bimekizumab in over 500 patients

Axial spondyloarthritis is a type of inflammatory arthritis affecting the joints of the spine, chest, and pelvis. It includes nonradiographic axSpA (nr-axSpA), where no damage is visible on an X-ray, and radiographic axSpA (r-axSpA), also known as ankylosing spondylitis (AS), where such damage is visible.

Bimekizumab is a monoclonal antibody designed to block the activity of interleukin-17A, known as IL-17A, and interleukin-17F, called IL-17F. These two molecules are implicated in inflammation.

Data from an earlier Phase 2b study indicated that the treatment could help reduce symptoms of AS. It’s now approved in the U.S. to treat plaque psoriasis under the brand name Bimzelx.

The therapy, developed by UCB, was approved in Europe this year to treat axSpA. That approval was based on two Phase 3 trials that evaluated the safety and efficacy of bimekizumab: BE MOBILE 1 (NCT03928704), which included 254 people with nr-axSpA, and BE MOBILE 2 (NCT03928743), which enrolled 332 people with AS.

In both trials, patients randomly received 160 mg of bimekizumab or a placebo — given via subcutaneous, or under the skin, injection — every four weeks for 16 weeks, or about four months. Then, all participants were treated with bimekizumab for up to one year.

Among the patients enrolled in BE MOBILE 1, 244 (96%) completed the 16-week phase, and 220 (87%) completed all 52 weeks. In BE MOBILE 2, the completion rate was 97% (322 patients) at week 16, and 90% (298 patients) at one year.

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Treatment with bimekizumab provided sustained benefits

Both trials met their main goal of at least 40% improvement on the Assessment of SpondyloArthritis International Society (ASAS40). This measure evaluates four areas: back pain, physical function, inflammation, and a patient global assessment of disease activity.

The percentage of patients who achieved an ASAS40 response was sustained throughout both trials. At week 16, 48% of people with nr-axSpA and 45% of those with AS had achieved this, and 61% of nr-axSpA patients and 58% of AS patients had done so after one year.

Treatment with bimekizumab provided sustained benefits in measures of disease activity compared with the placebo. The researchers noted improvements in C-reactive protein levels and MRI scans of the sacroiliac joints and spine, which are both used to assess inflammation. One year of treatment also improved patients’ physical function and quality of life, while easing spinal pain and morning stiffness.

After one year, the results from patients who switched from the placebo to bimekizumab at 16 weeks were comparable to the results of those who had been taking bimekizumab since the trials’ beginning.

For example, at the start of the studies, 73% of nr-axSpA patients and 60% of the AS group had enthesitis — inflammation of the sites where tendons or ligaments attach to bone. After one year, complete resolution of this issue was achieved by 54% of the nr-axSpA patients who’d been taking bimekizumab all 52 weeks, and 45% of those who’d started with the placebo. Similar findings were observed for AS patients.

Also, among AS patients, the results were similar regardless of whether or not they had taken anti-TNF medications — therapies that block a key protein in inflammation.

The observed efficacy of [bimekizumab] across measures of disease activity, patient-reported outcomes and peripheral manifestations demonstrates the potential of [bimekizumab] to elicit sustained responses in clinically relevant therapeutic targets.

Safety results of bimekizumab in the trials were consistent with the therapy’s known profile. After one year, at least one treatment-emergent adverse event was reported in 183 of those with nr-axSpA (75%) and in 249 people with AS (76%). Serious adverse events occurred in nine nr-axSpA patients and in 20 AS patients.

The most frequently reported adverse events included the common cold (12.3% of nr-axSpA patients and 9.1% of AS patients), upper respiratory tract infection (9.4% of nr-axSpA patients and 6.4% of those with AS), and oral candidiasis, a fungal infection (7.4% in the nr-axSpA group and 6.1% in AS).

Uveitis, an inflammatory condition of the eye, occurred in three people with nr-axSpA and seven with AS, while definite or probable inflammatory bowel disease was reported in two people with nr-axSpA and three with AS.

The long-term efficacy and safety of bimekizumab after up to three years of treatment is being assessed in the ongoing open-label extension study BE MOVING (NCT04436640). The upcoming five-year results of the BE AGILE Phase 2 trial (NCT02963506) also will provide further data on the treatment.

Overall, “the observed efficacy of [bimekizumab] across measures of disease activity, patient-reported outcomes and peripheral manifestations demonstrates the potential of [bimekizumab] to elicit sustained responses in clinically relevant therapeutic targets,” the researchers concluded.