Data from the BE VITAL OLE study, which included patients from the BE COMPLETE and BE OPTIMAL studies, suggests the benefits of bimekizumab in patients with psoriatic arthritis with inadequate response or intolerance to TNF inhibitors were sustained for up to 52 weeis.
New data from the BE COMPLETE study and its 52-week open-label extension provide new insight into the effects of bimekizumab on disease activity in patients with psoriatic arthritis who have struggled to achieve adequate response or have intolerance to tumor necrosis factors (TNF) inhibitors.
Results of the study, which add to the 16-week results of the trial, indicate the clinically meaningful improvements in composite measures of disease activity for both joint and skin domains seen with bimekizumab at 16 weeks were sustained out to 52 weeks.
“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.2
A phase 3 multicenter, randomized, double-blind, placebo-controlled trial, BE COMPLETE, which was presented at ACR Convergence 2022, was launched with the intent of exploring the effects of bimekizumab use in patients with psoriatic arthritis with an inadequate response to TNF inhibitors. Conducted in 92 centers across 11 countries, the trial enrolled 400 patients.1
For inclusion in the study, patients needed to be 18 years or older with adult-onset psoriatic arthritis with a history of inadequate response or intolerance to treatment with one or two TNF inhibitors for either psoriatic arthritis or psoriasis. Of note, a diagnosis of adult-onset psoriatic arthritis was defined as meeting the Classification Criteria for Psoriatic Arthritis for at least 6 months before screening.1
Overall, the trial enrolled and randomized 400 patients in a 2:1 ratio to either subcutaneous bimekizumab 160 mg every 4 weeks or placebo therapy. At the conclusion of the 16-week treatment period, the trial met its primary endpoints with significantly more patients treated with bimekizumab achieving 50% or greater improvement in disease activity from baseline relative to placebo, with disease activity measured by the American College of Rheumatology (ACR) 50 response.1
Patients who completed the trial were invited to participate in the BE VITAL open-label extension study. In addition to the 377 patients from the BE COMPLETE study, the BE VITAL OLE study also contained data from 347 patients from the BE OPTIMAL study.1
Upon analysis, results of the BE VITAL OLE study indicated efficacy of bimekizumab was sustained to week 52 in those randomized to bimekizumab treatment at week 0 as well as those who switched to bimekizumab at week 16 demonstrated improvements in efficacy responses out to week 52. At week 16, minimal disease activity was achieved by 6% of the placebo arm and 44.2% of bimekizumab-treated patients. At week 52, minimal disease activity was achieved by 33.1% of the group who started with placebo therapy at week 0 and 47.2% in those who received bimekizumab in week 0. Investigators also noted improved or sustained responses were observed for the proportions of bimekizumab patients achieving very low disease activity, ACR 50 and Psoriasis Area and Severity Index 100, Disease Activity Index for Psoriatic Arthritis and Psoriatic Arthritis Disease Activity Score thresholds at week 52.1
“Psoriatic arthritis and axial spondylarthritis 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 spondylarthritis,” said Emmanuel Caeymaex, executive vice president of Immunology and US Solutions with UCB.2