The Lancet publishes results from two bimekizumab phase III studies in psoriatic arthritis
UCB, announced that The Lancet has published two articles detailing 24-week results from the Phase III BE OPTIMAL study and 16-week results from the Phase III 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
Data from BE OPTIMAL and BE COMPLETE show that both studies met their primary and all ranked secondary endpoints. 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.
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.
See-"Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase III trial (BE OPTIMAL)": Prof Iain B McInnes, MD, Prof Akihiko Asahina, MD, Laura C Coates, PhD. et al. Open AccessPublished:December 05, 2022DOI:https://doi.org/10.1016/S0140-6736(22)02302-9.
See-"Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor inhibitors: a randomised, double-blind, placebo-controlled, phase III trial (BE COMPLETE)":Joseph F Merola, MD, Prof Robert Landewé, MD, Prof Iain B McInnes, FRCP, Prof Philip J Mease, MD.et al. Open AccessPublished:December 06, 2022DOI:https://doi.org/10.1016/S0140-6736(22)02303-0.
Related news and insights
Medtronic announced the United States launch of the Penditure left atrial appendage (LAA) exclusion system, an implantable clip preloaded on a single-use delivery system for LAA management during concomitant cardiac surgery procedures
GSK plc announced positive headline results from a planned interim efficacy analysis of the DREAMM-7 head-to-head phase III trial evaluating belantamab mafodotin as a second-line treatment for relapsed or refractory multiple myeloma