Two-Year Phase III Data Confirm Long-Term Efficacy, Safety of Bimzelx in Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, Ankylosing Spondylitis

Bimzelx. Image Credit: UCB

Two-year data from a series of Phase III trials and their open label extensions reinforced the long-term efficacy and safety of Bimzelx (bimekizumab-bkzx) in the treatment of active psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS).¹ Bimzelx is a humanized monoclonal IgG1 antibody that was developed to selectively inhibit the interleukin (IL)-17A and IL-17F, both of which are key cytokines that drive inflammatory processes.

“These new two-year data, revealing high levels of response, offer exciting insights into [Bimzelx’s] sustained efficacy in non-radiographic axial spondyloarthritis, ankylosing spondylitis, and psoriatic arthritis,” Fiona du Monceau, head of Patient Evidence, UCB, said in a press release. “The results reinforce the potential of bimekizumab-bkzx as an effective approach to targeting key inflammatory pathways involved in PsA, nr-axSpA, and AS through dual inhibition of IL-17A and IL-17F, reflecting our ambition to provide differentiated treatments for people living with chronic inflammatory diseases.”¹

Bimzelx was approved by the FDA to treat adults with PsA, nr-axSpA, and AS in September 2024.² The regulatory action represented the first approval of a medication for these conditions that selectively inhibits IL-17A and IL-17F. The drug was also approved by the FDA in October 2023 for adults with moderate to severe plaque psoriasis who are eligible for systemic therapies or phototherapies. It was also the first and only approved psoriasis treatment that selectively inhibits IL-17A and IL-17F.³

The latest long-term data for Bimzelx were gathered from the Phase III trials BE OPTIMAL (PsA), BE COMPLETE (PsA), and their open-label extension BE VITAL; and the Phase III BE MOBILE 1 (nr-axSpA), BE MOBILE 2 (AS), and their open-label extension BE MOVING.

The results showed strong maintenance of clinical responses, which includes complete skin clearance, minimal disease activity, improved joint pain, and patient reported outcomes across two years. Among week 16 responders, more than seven in 10 were able to sustain a 50% improvement in ACR response criteria over two years.

These responses were found to be consistent regardless of whether patients had ever taken a biologic disease-modifying anti-rheumatic drug before or having shown an inadequate response or intolerance to prior treatment with tumor necrosis factor inhibitors, according to the investigators. In patients with nr-axSpA and AS, two-year data showed Bimzelx maintained high levels of efficacy across all domains of axSpA and long-term maintenance of limited disease activity and remission, with more than eight in 10 who achieved ASAS40 at week 16 maintaining the response for two years.

One-year data showed that more patients with nr-axSpA or AS administered Bimzelx achieved remission as defined by objective signs of inflammation compared to ASDAS-Inactive Disease (ASDAS-ID), which investigators said emphasizes the need for optimized endpoints that guide clinical management of axSpA treatment. In terms of safety, a pooled analysis including data from three Phase IIb/III trials and their open-label extensions in patients with active nr-axSpA, AS, and active PsA showed the profile of Bimzelx to be consistent with prior findings and no new safety signals were reported.

A prior trial of the drug in patients with axSpA showed that the most commonly reported treatment-emergent adverse events in patients administered Bimzelx by exposure-adjusted incidence rate per 100 patient-years were SARS-CoV-2 infection (13.2), nasopharyngitis (10.2), and upper respiratory tract infection (6.0).⁴

“A major challenge for practicing rheumatologists is that existing treatments may lose efficacy over time, leaving patients vulnerable to debilitating symptoms,” Dr. Fabian Proft, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Germany, said in the release. “The new results presented at ACR Convergence 2024 show that [Bimzelx] met stringent clinical endpoints, with high levels of efficacy across multiple domains of axial spondyloarthritis and psoriatic arthritis, and were sustained for two years, demonstrating [Bimzelx’s] ability to remain effective over the long term.”¹

References

1. New BIMZELX® (bimekizumab-bkzx) Data at ACR Convergence 2024 Highlights UCB’s Efforts to Deliver Differentiated Care for Patients with Psoriatic Arthritis and Axial Spondyloarthritis. News release. UCB. November 14, 2024. Accessed November 15, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/new-bimzelxr-bimekizumab-bkzx-data-at-acr-convergence-2024-highlights-ucbs-efforts-to-deliver-differentiated-care-for-patients-with-psoriatic-arthritis-and-axial-spondyloarthritis

2. UCB Announces U.S. FDA Approvals for BIMZELX® (bimekizumab-bkzx) for the Treatment of Psoriatic Arthritis, Non-radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis. News release. UCB. September 23, 2024. Accessed November 15, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-announces-us-fda-approvals-for-bimzelxr-bimekizumab-bkzx-for-the-treatment-of-psoriatic-arthritis-non-radiographic-axial-spondyloarthritis-and-ankylosing-spondylitis

3. BIMZELX Approved by the U.S. FDA for the Treatment of Adults with Moderate-to-Severe Plaque Psoriasis. UCB. News release. October 18, 2023. Accessed November 15, 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

4. UCB to share first presentations of BIMZELX® (bimekizumab-bkzx) two-year data in axial spondyloarthritis and psoriatic arthritis at EULAR 2024. News release. June 12, 2024. Accessed November 15, 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