The Lancet Publishes Results from Two Bimekizumab Phase 3 Studies in Psoriatic Arthritis

Two articles report results from the Phase 3 BE OPTIMAL and BE COMPLETE studies evaluating bimekizumab, a selective inhibitor of IL-17A and IL-17F, in patients with psoriatic arthritis

Brussels (Belgium), 7th December 2022 – 07:00 (CET) – UCB, a global biopharmaceutical company, today announced that The Lancet  has published two articles detailing 24-week results from the Phase 3 BE OPTIMAL study and 16-week results from the Phase 3 BE COMPLETE study, evaluating the efficacy and safety of bimekizumab in the treatment of adults with active psoriatic arthritis who were biologic-naïve and tumour necrosis factor inhibitor inadequate responders (TNFi-IR), respectively.^1,2

“Publication of two articles in tandem in The Lancet, one of the world’s most prestigious peer-reviewed journals, highlights the significance of these Phase 3 bimekizumab studies to the medical community. We look forward to continuing to work with regulatory agencies to make bimekizumab available to people living with psoriatic arthritis as soon as possible,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US, UCB.

Data from BE OPTIMAL and BE COMPLETE show that both studies met their primary and all ranked secondary endpoints.^1,2 A significantly higher proportion of patients treated with bimekizumab achieved improvements in joint symptoms at week 16 compared with placebo – as measured by ACR50, the primary endpoint – with a consistent clinical response observed in both biologic-naïve and TNFi-IR populations (p<0.0001 for each). In addition, at week 16, a significantly higher proportion of bimekizumab-treated patients compared with placebo achieved high levels of skin clearance – as measured by PASI 90, a secondary endpoint – with a consistent clinical response in both populations (p<0.0001 for each). The safety profile of bimekizumab was consistent with safety data seen in previous studies with no new observed safety signals.^1,2

In September 2022, UCB announced that the European Medicines Agency had accepted the marketing authorization application for bimekizumab for the treatment of active psoriatic arthritis in adults. 

The efficacy and safety of bimekizumab in the treatment of psoriatic arthritis have not been established and it is not approved for the treatment of psoriatic arthritis by any regulatory authority worldwide.

References

1.     McInnes I.B., Asahina A, Coates L.C. et al. Bimekizumab in patients with psoriatic arthritis, naïve to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL) The Lancet. 2022. Published online. Available at:  https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02302-9/fulltext

2.     Merola J.F., Landewé R, McInnes I.B. et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE) The Lancet. 2022. Published online. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02303-0/fulltext

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2. Mease PJ, Armstrong AW. Managing patients with psoriatic disease: The diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014;74(4):423–441.
3. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991–1001.
4. BIMZELX^® (bimekizumab) EU Summary of Product Characteristics. 
   https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last accessed: December 2022.
5. BIMZELX^® (bimekizumab) GB Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/12834; https://www.medicines.org.uk/emc/product/12833. Last accessed: December 2022.