MHRA (UK) approves Bimzelx for patients with active psoriatic arthritis and adult patients with active axial spondyloarthritis – UCB

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for bimekizumab (Bimzelx, UCB) for patients with active psoriatic arthritis and adult patients with active axial spondyloarthritis.

Bimekizumab is a humanised monoclonal IgG1 antibody designed to inhibit both IL-17A and IL-17F – two key cytokines driving inflammatory disease – selectively and directly. It was first approved in the UK in August 2021 for the treatment of adults with moderate to severe plaque psoriasis who were candidates for systemic therapy.

Psoriatic arthritis affects over 600,000 people in the UK, and often affects the small joints of the hands and feet. Axial Spondyloarthritis, which includes ankylosing spondylitis, affects 220,000 people in the UK and causes significant and long-lasting pain in the lower back, buttocks, and hips.

Professor Karl Gaffney, consultant rheumatologist at The Norfolk and Norwich University Hospital NHS Foundation Trust, explained that psoriatic arthritis and axial spondyloarthritis were chronic, painful conditions “with no cure”. He pointed out that “the unfortunate reality for many patients is that they will have to cycle through a number of treatments before eventually finding one that works for them”.

The MHRA has approved bimekizumab, alone or in combination with methotrexate, for the treatment of adults with active psoriatic arthritis who have had an inadequate response or have been intolerant to one or more disease-modifying antirheumatic drugs.

In active axial spondyloarthritis, the MHRA has approved bimekizumab for the treatment of adults with active non-radiologic axial spondyloarthritis with objective signs of inflammation, as indicated by elevated C-reactive protein and/or magnetic resonance imaging, who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs, and for the treatment of adults with active ankylosing spondylitis (also now known as radiographic axial spondyloarthritis) who have responded inadequately or are intolerant to conventional therapy.