Bimzelx and psoriatic arthritis long term data

[Fred]

In patients with psoriatic arthritis with prior inadequate response to tumour necrosis factor inhibitors, Bimzelx (bimekizumab) demonstrated sustained joint and skin clearance responses to week 52.

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UCB today announced new long-term 52-week data from three Phase 3 studies – BE COMPLETE with its long-term extension study, BE MOBILE 1 and BE MOBILE 2 – evaluating the efficacy and safety profile of bimekizumab, an inhibitor of IL-17F in addition to IL-17A, in adults with active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) and active ankylosing spondylitis (AS), also known as radiographic axSpA (r-axSpA), respectively. These results from the bimekizumab phase 3 program in PsA and axSpA are being presented at the European Congress of Rheumatology, EULAR 2023, in Milan, Italy, May 31–June 3. The safety and efficacy of bimekizumab in PsA, nr-axSpA and r-axSpA have not been established, and it is not approved for use in PsA, nr-axSpA or AS by any regulatory authority worldwide.

“Psoriatic arthritis and axial spondyloarthritis are chronic and progressive inflammatory diseases requiring long-term management. The new long-term bimekizumab data presented at EULAR 2023 showed sustained clinical responses across multiple disease manifestations and patient populations up to one year. These results reinforce our belief in bimekizumab as a potential new future treatment for patients living with psoriatic arthritis and axial spondyloarthritis,” said Emmanuel Caeymaex, Executive Vice President, Immunology and U.S. Solutions, UCB.

Bimekizumab 52-week PsA data: patients with prior inadequate response to tumour necrosis factor inhibitors (TNFi-IR)
Key 52-week results from the BE COMPLETE open-label extension study (BE VITAL) build on the previously announced 16-week results from the BE COMPLETE study and 52-week results from the BE OPTIMAL study.

“The long-term data from BE COMPLETE showed that over six out of 10 patients continuously treated with bimekizumab achieved complete skin clearance and almost one in two had minimal disease activity at week 52. These results complement the previously reported 52-week results from the BE OPTIMAL study and highlight the consistent and sustained response seen with bimekizumab in both biologic-naïve and TNF inhibitor-experienced patients with psoriatic arthritis,” said Professor Iain McInnes, University of Glasgow, College of Medicinal Veterinary and Life Sciences, Glasgow, Scotland. 

• American College of Rheumatology (ACR) 50: At week 52, 51.7 percent of psoriatic arthritis patients (TNFi-IR) continuously treated with bimekizumab (160 mg every four weeks [Q4W]; n=267), and 40.6 percent of patients who switched from placebo to bimekizumab at week 16 (n=133) achieved ACR50.
  
• Complete Skin Clearance (PASI100): At week 52, in patients with baseline psoriasis ≥3 percent body surface area, 65.9 percent of patients continuously treated with bimekizumab (n=176) and 60.2 percent of patients who switched from placebo to bimekizumab at week 16 (n=88) achieved complete skin clearance (PASI100).
  
• Minimal Disease Activity (MDA): At week 52, 47.2 percent (n=126/267) of patients continuously treated with bimekizumab and 33.1 percent (n=44/133) of patients who switched from placebo to bimekizumab achieved MDA.
  

Over 52 weeks, 62.6 percent (n=243/388) of patients treated with bimekizumab had ≥1 treatment emergent adverse event (TEAE) and 5.9 percent (n=23/388) reported a serious TEAE.1 Candida infections were reported by 6.4 percent (n=25/388) of patients receiving bimekizumab with all cases reported as mild or moderate and none reported as systemic.

Source: ucb.com

Bimzelx (bimekizumab)