Insights into Bimekizumab 2-Year Data for PsA, nr-asSpA, and AS

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Last month, UCB presented 2-year data from the phase 3 studies evaluating bimekizumab (Bimzelx; UCB) for psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS) at EULAR 2024 in Vienna, Austria. Researchers behind the study gave Dermatology Times a deeper look into the study, the results, what dermatology clinicians will want to keep in mind when collaborating with rheumatologists, and what may come next in a recent Q&A.¹

Background

Bimekizumab is currently approved in the US for moderate-to-severe plaque psoriasis, but its efficacy and safety in treating PsA, nr-axSpA, and AS are still under investigation.² The data suggest promising long-term outcomes and a potential impact on disease progression in axial spondyloarthritis, particularly AS, which was emphasized in late-breaking presentations.

Q&A

PsA Insights – Laura Coates, PhD

How did the patient-reported outcomes in PsA patients treated with bimekizumab align with clinical assessments like DAPSA?

There is quite good agreement between clinical assessments like joint counts and other physician assessments with patient-reported outcomes, including in this trial. We generally see that patients identify similar improvements in symptoms alongside the signs assessed by clinicians.

Did patients who achieved Disease Activity Index for Psoriatic Arthritis (DAPSA) low disease activity/remission or minimal disease activity treated with bimekizumab also have improvements in patient-reported outcomes?

The association between clinical assessments and patient-reported outcomes was not part of this analysis, but previous data have shown that patients treated with bimekizumab that achieve high treatment targets such as DAPSA low disease activity (LDA)/remission (REM) or minimal disease activity have a better quality of life and function, and less pain, fatigue and disease impact than those who do not achieve LDA/REM.

Were there notable differences in treatment response between biologic-naïve patients and those who had previously received biologic therapies?

Regardless of whether patients were biologic-naïve or TNFi-IR, those treated with bimekizumab sustained MDA/DAPSA LDA/remission out to 2 years. This response was similar between the 2 populations.

axSpA Insights – Xenofon Baraliakos, MD, PhD

Were there any specific subgroups within the axSpA population where bimekizumab demonstrated particularly robust efficacy and safety outcomes?

The data showed that patients with nr-axSpA and those radiographic axSpA, also known as AS, achieved sustained and consistent clinical and patient-reported outcomes up to 2 years, when treated with bimekizumab.

Specifically, across the full disease spectrum of axSpA, approximately 1 in 2 patients treated with bimekizumab over 2 years achieved and maintained ASAS40 – a 40 percent or greater improvement in signs and symptoms of axSpA. At two years, approximately 6 in 10 patients with either nr-axSpA or AS achieved ASDAS low disease activity, ASDAS <2.1, (Ankylosing Spondylitis Disease Activity Score) and 3 in 10 achieved a state of inactive disease (ASDAS <1.3). Importantly, results were consistent across patients who were new to biologics and those with prior inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).

The safety profile of bimekizumab in axSpA over 2 years was consistent with previous studies with no new safety signals observed. Incidence of uveitis was low; exposure-adjusted incidence rate per 100 patient-years (EAIR/100 PY): 1.6.

Can you discuss any unexpected findings or outcomes that emerged from the post hoc analyses of the BE MOBILE 1 (NCT03928704)and BE MOBILE 2 (NCT03928743)studies?

Prevention of structural damage is a key treatment goal for patients with axSpA, as spinal radiographic damage is an important determinant of spinal mobility and functional impairment. Current thinking suggests that inflammation identified on magnetic resonance imaging (MRI) leads to local repair processes and subsequent new bone formation, indicating that early anti-inflammatory treatment may not only halt inflammation but also prevent subsequent new bone formation and radiographic progression.

The 1-year results and post hoc analyses from BE MOBILE 1 and BE MOBILE 2 showed that treatment with bimekizumabsubstantially improved MRI inflammation, reduced erosions and increased backfill and fat in the sacroiliac joints of patients with both nr-axSpA and AS, suggesting evidence of tissue repair. Along with these findings the late-breaking radiographic progression data in patients with AS treated with bimekizumab revealed that over 90 percent of patients showed no spinal radiographic progression over 2 years, as defined by modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) change from baseline <2.

The totality of imaging data for bimekizumab presented at this year’s EULAR conference underscores the effect of bimekizumab treatment on halting active inflammation and radiographic progression, and is suggestive of tissue repair following treatment with bimekizumab.

Moving Forward - UCB

Looking ahead, what are the next steps in the clinical development of bimekizumab?

Earlier this year, the FDA accepted for review the supplemental Biologics License Applications (sBLAs) for bimekizumab in nr-axSpA, AS, and PsA. UCB expects FDA action on all 3 indications before the end of 2024. If approved, bimekizumab will be the first and only IL-17A and IL-17F inhibitor available in the US for the treatment of these rheumatic diseases.

References

1. UCB to share first presentations of bimzelx (bimekizumab-bkzx) two-year data in axial spondyloarthritis and psoriatic arthritis at EULAR 2024. News release. UCB. June 12, 2024. Accessed July 24, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-to-share-first-presentations-of-bimzelxr-bimekizumab-bkzx-two-year-data-in-axial-spondyloarthritis-and-psoriatic-arthritis-at-EULAR-2024 
2. BIMZELX® approved by the US FDA for the treatment of adults with moderate-to-severe plaque psoriasis. News Release. UCB. October 18, 2023. Accessed July 24, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelx-approved-by-the-us-fda-for-the-treatment-of-adults-with-moderate-to-severe-plaque-psoriasis#:~:text=ATLANTA%2C%20October%2018%2C%202023%20%E2%80%93,in%20adults%20who%20are%20candidates