Bimekizumab Shows Long-Term Efficacy in Nonradiographic AxSpA, Ankylosing Spondylitis

Data presented at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual European Congress of Rheumatology demonstrated the efficacy of bimekizumab at 2 years among patients with nonradiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS).^1,2

Xenofon Baraliakos, MD, PhD, professor of internal medicine and rheumatology at Ruhr-University Bochum in Bochum, Germany | Image Credit: Ruhr-University Bochum

Xenofon Baraliakos, MD, PhD, primary investigator of several studies on bimekizumab presented at EULAR 2024 and professor of internal medicine and rheumatology at Ruhr-University Bochum in Bochum, Germany, spoke with The American Journal of Managed Care^® (AJMC^®) via email to discuss findings surrounding bimekizumab in nr-axSpA and AS.

One study examined the efficacy and safety of bimekizumab at 2 years in the BE MOBILE 1 (NCT03928704) and BE MOBILE 2 (NCT03928743) studies, which encompass patients across the spectrum of axSpA.¹ Late-breaking data showed that patients with AS in the BE MOBILE 2 study had minimal spinal radiographic progression over 2 years of treatment with bimekizumab,² which is not yet approved for nr-axSpA or AS in the US.

Bimekizumab is currently FDA approved for moderate to severe plaque psoriasis in candidates for systemic therapy or phototherapy, and a supplemental biologics license was accepted by the FDA for bimekizumab in nr-axSpA and AS earlier this year.³

this transcript has been lightly edited for clarity.

AJMC: What were the main findings in the study on long-term efficacy across the spectrum of AS, and how do the data at 2 years of follow-up compare with prior data? Were any findings surprising?

Baraliakos: The data showed that patients with nr-axSpA and those with AS, also known as radiographic axSpA, experienced sustained and consistent clinical and patient-reported outcomes up to 2 years when treated with bimekizumab.¹ Specifically, across the spectrum of axSpA, approximately 1 in 2 patients treated with bimekizumab over 2 years achieved and maintained ASAS40—a 40% or greater improvement in signs and symptoms of axSpA.

At 2 years, approximately 6 in 10 patients with either nr-axSpA or AS achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) low disease activity (ASDAS < 2.1), and 3 in 10 achieved a state of inactive disease (ASDAS < 1.3). The safety profile of bimekizumab in axSpA over 2 years was consistent with previous studies, with no new safety signals observed.

These 2-year data build on the published 52-week data and show that dual inhibition of interleukin (IL)-17A and IL-17F with bimekizumab resulted in sustained and consistent response for patients across the full spectrum of axSpA.

AJMC: What were the main findings of the open-label extension study, and what do they add to what we know about the efficacy of bimekizumab in radiographic axSpA? How do the radiographic findings translate to clinical progression of axSpA?

Baraliakos: In addition to the 2-year results on AS shared above, late-breaking data showed that the majority of patients with AS treated with bimekizumab had no spinal radiographic progression over 2 years.² More specifically, more than 90% of patients—92.1%—with AS treated with bimekizumab showed no spinal radiographic progression over 2 years, as defined by modified Stoke Ankylosing Spondylitis Spinal Score change from baseline of less than 2.

Limiting structural progression through the abrogation of inflammation is essential since structural changes can lead to pain, decreased mobility, limited function, and impaired quality of life in patients with AS.

AJMC: How does the efficacy and tolerability of bimekizumab compare with the current standards of care in axSpA?

Baraliakos: AxSpA, which includes both nr-axSpA and AS, is a chronic, immune-mediated, inflammatory disease. With the appropriate therapy, progression of the disease can be slowed down. There is a need for additional treatment options since some people may not achieve long-term disease control.

The 52-week BE MOBILE 1 and BE MOBILE 2 phase 3 studies in nr-axSpA and AS, respectively, assessed bimekizumab across key clinical response criteria, measures of disease activity, patient-reported outcomes, and peripheral manifestations of disease.¹ Improvements across a range of outcomes at week 16 were sustained to week 52, with the safety profile consistent with previous studies. The most recent 2-year data showed that 1-year responses were sustained to 2 years in patients with both nonradiographic axSpA and ankylosing spondylitis.

AJMC: What are the main treatment goals at different stages of axSpA, and how has bimekizumab been shown to address them?

Baraliakos: At every stage of axSpA, the goal of treatment is to control inflammation in order to reduce symptoms, improve function, limit progression, and maintain quality of life. Treatments are needed that can improve patient symptoms rapidly; however, since axSpA is a chronic disease that can lead to spinal damage and disability, treatments that provide long-term sustained control of inflammation are equally needed.

The bimekizumab data in axSpA showed that patients with nonradiographic axSpA and AS achieved sustained suppression of inflammation over 2 years.^1,2 Patients reported sustained improvements in symptoms, including spinal pain, morning stiffness, and fatigue. Additionally, more than 90% of patients with AS treated with bimekizumab showed no spinal radiographic progression over 2 years, as defined by modified Stoke Ankylosing Spondylitis Spinal Score change from baseline of less than 2.²

References

1. Baraliakos X, Deodhar A, Van der Heijde D, et al. Minimal spinal radiographic progression in patients with radiographic axial spondyloarthritis over 2 years of bimekizumab treatment: results from a phase 3 open-label extension study. Poster presented at: EULAR 2024 Congress; June 12-15, 2024; Vienna, Austria. Poster POS0806.

2. Baraliakos X, Ramiro S, Maksymowych WP, et al. Long-term sustained efficacy and safety of bimekizumab across the full spectrum of axial spondyloarthritis: 2-year results from two phase 3 studies. Poster presented at: EULAR 2024 Congress; June 12-15, 2024; Vienna, Austria. Poster LBA0003.

3. McGovern G. FDA accepts sBLA For bimekizumab-bkzx in 3 new spondyloarthritides indications. Pharmacy Times^®. February 28, 2024. Accessed June 28, 2024. https://www.pharmacytimes.com/view/fda-accepts-sbla-for-bimekizumab-bkzx-in-3-new-spondyloarthritides-indications