
OR WAIT null SECS
In the phase 3b BE RADIANT trial and its open-label extension, bimekizumab treatment led to durable improvements in patient-reported outcomes over 3 years.
Bimekizumab therapy for individuals with plaque psoriasis may improve patient-reported outcomes (PROs) and health-related quality of life as early as 4 weeks and through 3 years of use, new data suggest.1
These findings on bimekizumab’s use in psoriasis were authored by such investigators as Matthias Augustin, MD, PhD, of the University Medical Center Hamburg-Eppendorf’s Institute for Health Services Research in Dermatology and Nursing (IVDP), and published in JAMA. According to Augustin et al, the BE RADIANT study was the first phase 3 analysis to evaluate dual inhibition of interleulin (IL)-17F and IL-17A versus IL-17A alone, by making a comparison of the impact and safety of bimekizumab with secukinumab.2
“Herein, we report an in-depth post hoc analysis of short- and long-term PROs, as well as concurrent achievement of clinical and health-related quality of life outcomes, in patients with moderate to severe plaque psoriasis from the BE RADIANT phase 3b trial,” Augustin and coauthors wrote.1
The investigative team highlighted several key facts about the BE RADIANT study, noting the multicenter, phase 3, randomized clinical trial also involved an open-label extension (OLE). It was made up a 48-week double-blind treatment period followed by a 96-week OLE, with a total of 3 years of therapy being included. Those assessed were initially assigned to be treated either with bimekizumab or secukinumab. At the 48-week mark, during entry into the OLE, subjects originally randomized to bimekizumab continued the same therapy (continuous bimekizumab cohort). Meanwhile, those assigned to secukinumab shifted to bimekizumab (secukinumab/bimekizumab cohort).
Outcomes included patient-reported skin pain, pruritus, and scaling symptoms, evaluated via the Psoriasis Symptoms and Impacts Measure (P-SIM). Additionally, the investigators looked at rates of complete skin clearance (Psoriasis Area and Severity Index [PASI] = 0) achievement and minimal quality-of-life impact (Dermatology Life Quality Index [DLQI] 0/1) attainment. Efficacy through the 1-year mark was assessed via nonresponder imputation, and data from years 1 - 3 were assessed via modified nonresponder imputation.
Those involved in the continuous bimekizumab arm were given 320 mg every 4 weeks through Week 16, and this was followed by dosing every 4 or 8 weeks through the first year and into the OLE period. Subjects initially treated with secukinumab received 300 mg every 4 weeks through Year 1, after which they shifted to bimekizumab 320 mg every 4 or 8 weeks. By the 64-week mark, all subjects were on bimekizumab, administered every 8 weeks. At the point of baseline, 373 individuals were randomized to bimekizumab and 370 to secukinumab; 336 and 318 individuals, respectively, were entered into the OLE.
By the 4-week mark, Augustin and colleagues noted a greater proportion of those in the bimekizumab group saw a complete resolution of their symptoms compared with those on secukinumab.1 Specifically, the team observed the absence of itching by 34.0% of those in the bimekizumab arm versus 25.1% of those in the secukinumab arm; a lack of skin pain was noted among 74.5% versus 222 60.0%; and a lack of scaling by 46.1% versus 21.6%, respectively.
Such differences persisted through the 1-year mark. Pruritus was still absent in 60.9% of those on bimekizumab versus 48.1% of those on secukinumab (nominal P < .001). In a similar set of findings, Augustin et al found 78.6% versus 70.8% had no skin pain (nominal P = .01), and 70.5% versus 49.7% saw no scaling (nominal P < .001), respectively.
Simultaneous PASI = 0 and DLQI 0/1 attainment was also observed by the investigative team more commonly among the bimekizumab cohort. At the 4-week mark, 11.5% in the bimekizumab group were shown to have achieved both endpoints compared with 4.6% in the secukinumab cohort (nominal P < .001). By the 1-year mark, such rates rose to 61.7% versus 42.7%, respectively (nominal P < .001). Among the individuals entered into the OLE, the high rates of complete symptom resolution on the P-SIM (score = 0) were sustained through the 3-year mark.
By the OLE’s initiation, concurrent PASI = 0 and DLQI 0/1 responses were noted by the investigators among 69.2% of continuous bimekizumab-treated individuals and 48.5% of individuals switching from secukinumab. Following the transition to bimekizumab, the response rates in the secukinumab/bimekizumab arm were noted to have improved. Additionally, by Year 3, similarly high proportions were maintained in both the continuous bimekizumab group and the switch group (62.2% and 63.8%, respectively).
“Many patients treated with bimekizumab had concurrent improvements in clinical outcomes and PROs, both of which are important for informing treatment decisions, suggesting that bimekizumab’s high clinical efficacy translates into benefits to patient-perceived symptoms and health-related quality of life,” the team concluded.1
References
Related Content: