July/August 2025 • PharmaTimes Magazine • 8

// CLINICAL TRIALS //


Bimekizumab shows lasting efficacy at EULAR 2025

Image

UCB has announced new three-year data from phase 3 trials and its open-label extensions investigating BIMZELX (bimekizumab) in psoriatic arthritis and axial spondyloarthritis.

The results, presented at EULAR 2025, show sustained inflammation control and significant long-term improvements in symptom relief and physical function.

In psoriatic arthritis, 53.2% of biologic-naïve patients and 55.2% of those with prior inadequate response to tumour necrosis factor inhibitors maintained ACR50 at three years. Swollen joints were eliminated in nearly 60% of patients, while approximately half achieved minimal disease activity, indicating strong inflammation control.

Professor Laure Gossec from Sorbonne University Hospital said: “These bimekizumab data are notable for their consistency across treatment-naïve and experienced patients.”

In axial spondyloarthritis, long-term efficacy was maintained across both non-radiographic and radiographic disease subtypes. ASAS40 was achieved by 60.4% of patients with non-radiographic axial spondyloarthritis and 60.1% with radiographic axial spondyloarthritis at three years. Low disease activity, measured by ASDAS, was maintained by 61.8% and 59.9% of patients, respectively.

Professor Xenofon Baraliakos from Ruhr University Bochum said: “These endpoints are key indicators of durable inflammation control in axial spondyloarthritis.”

Bimekizumab is the first and only approved treatment designed to selectively inhibit interleukin 17A and interleukin 17F. The data presented reinforce its potential as a long-term treatment option for chronic inflammatory diseases.


NICE recommends mirikizumab for Crohn’s disease treatment

The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending mirikizumab (Omvoh) for adults with moderately to severely active Crohn’s disease who have not responded to previous biological treatment or cannot tolerate it.

The decision comes less than two months after the Medicines and Healthcare products Regulatory Agency granted marketing authorisation for mirikizumab in the UK. It will be available to eligible patients in England within 30 days of publication of the final guidance and within 60 days in Wales.

Mirikizumab demonstrated positive outcomes in the phase 3 VIVID-1 trial, with 45% of treated patients achieving clinical remission at one year, compared to 20% on placebo. Additionally, 38% of treated patients had visible healing of the intestinal lining at one year, compared to 9% on placebo.

James Lindsay, professor of inflammatory bowel disease at Barts and the London School of Medicine and Dentistry, Queen Mary University of London, and consultant gastroenterologist at Barts Health NHS Trust, said: “Many patients with Crohn’s disease have explored several of the currently available therapies but are still seeking a treatment option that effectively helps manage their symptoms.”

Marianne Radcliffe, CEO of Crohn’s & Colitis UK, said: “Crohn’s disease is a lifelong condition affecting more than 200,000 people in the UK. Expanding the treatment options for eligible people living with Crohn’s – with drugs like mirikizumab – can only be a good thing!”