UCB has released new long-term data from its Phase 3 trials for BIMZELX (bimekizumab), a treatment for moderate-to-severe plaque psoriasis. The company presented the results at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris.
Bimekizumab is described as the first approved medication to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F). The new findings highlight sustained remission and disease control over three and four years, as well as the potential to reduce progression to psoriatic arthritis (PsA).
“Achieving high disease control is a key treatment target for all patients with plaque psoriasis, as it prevents the cumulative burden of disease and potentially progression to PsA,” said Richard B. Warren, Professor of Dermatology, University of Manchester and Northern Care Alliance NHS Foundation Trust. “It is therefore highly relevant to observe complete skin clearance sustained over four years in nearly half of patients who received bimekizumab, demonstrating long-term control of inflammation and the potential to improve patient outcomes.”
According to UCB, among patients who achieved complete skin clearance at week 16 and entered an open-label extension study (n=503), 48.9% maintained this response at every visit through year four. Additionally, 72% met criteria for remission with only minimal lapses in clearance during follow-up. High levels of body surface area control were also observed: 69.4% kept affected areas below or equal to one percent throughout four years, while 81.7% did so except for brief periods with slightly higher involvement.
Nail symptoms are also a concern in psoriasis management because they can indicate increased risk for PsA. In this analysis, more than 80% of patients achieved complete nail matrix or nail bed clearance by year three. Among those with multiple baseline risk factors for PsA, nearly all remained symptom-free over three years, and very few developed adverse events related to psoriatic arthritis over four years.
“The presentation of this three- and four-year data is further evidence of the depth and durability of response achieved with bimekizumab treatment in psoriasis, even at highly stringent measures of disease control,” said Donatello Crocetta, Head of Medical & Chief Medical Officer at UCB. “These results reinforce UCB’s commitment to developing evidence-driven solutions that aim to improve care for people living with chronic inflammatory diseases and reduce the risk of disease progression.”
The EADV Congress featured a total of 19 presentations from UCB on bimekizumab across various indications—including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis—and included an abstract on galvokimig, an investigational therapy for atopic dermatitis.
Plaque psoriasis is a chronic inflammatory skin condition affecting about two to three percent of people worldwide—approximately 125 million individuals (https://www.psoriasis.org/content/statistics). Symptoms may include red patches covered with silvery scales that itch or burn, cracked skin that can bleed, and changes in nails such as thickening or pitting (https://www.niams.nih.gov/health-topics/psoriasis#:~:text=Symptoms%20of%20psoriasis%20vary%20from,Thick%2C%20ridged%2C%20pitted%20nails).
Psoriatic arthritis is a systemic condition impacting both joints and skin; it affects around 30 percent of those diagnosed with psoriasis (https://www.psoriasis.org/about-psoriatic-arthritis/). It presents with joint pain or stiffness along with typical skin symptoms.
BIMZELX is currently approved in the European Union for several conditions: moderate-to-severe plaque psoriasis in adults eligible for systemic therapy; active psoriatic arthritis alone or combined with methotrexate; certain forms of axial spondyloarthritis; and moderate-to-severe hidradenitis suppurativa not responsive to conventional therapy.
The most common side effects reported include upper respiratory tract infections and oral candidiasis. Elderly patients may be more susceptible to some adverse reactions such as dermatitis or eczema when using bimekizumab. The drug should not be used by individuals allergic to its components or those with active infections like tuberculosis (https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf).
UCB is headquartered in Brussels and focuses on medicines targeting immune system disorders and central nervous system diseases. In 2024 it reported revenues totaling €6.1 billion.
For additional details about BIMZELX’s use or safety profile within Europe see the full product information provided by regulatory authorities (https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf).
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