4.6 Article

Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials

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BRITISH JOURNAL OF DERMATOLOGY
卷 188, 期 3, 页码 330-340

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OXFORD UNIV PRESS
DOI: 10.1093/bjd/ljac089

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This study evaluated the efficacy and safety of switching to bimekizumab from adalimumab, ustekinumab, and secukinumab. The results showed rapid and durable improvements in clinical responses among nonresponders who switched to bimekizumab. Furthermore, the majority of patients who responded well to previous treatments maintained or improved their response after switching to bimekizumab. Overall, switching to bimekizumab was found to be highly effective and well tolerated for psoriasis patients.
Background Discontinuation of biologics is common among patients with psoriasis due to treatment failure or adverse events. To achieve improvements in disease management, patients and clinicians may choose to switch biologics. Objectives To evaluate the efficacy and safety of switching to bimekizumab from adalimumab, ustekinumab and secukinumab. Methods Data are reported for up to 80 weeks after patients switched to bimekizumab from adalimumab at week 24 in BE SURE, ustekinumab at week 52 in BE VIVID [upon entry into the BE BRIGHT open-label extension (OLE)] and secukinumab at week 48 in BE RADIANT (upon entry into the BE RADIANT OLE). Efficacy outcomes are reported by number of weeks after switching to bimekizumab and were split based on whether patients had achieved a >= 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at the time of switch. Treatment-emergent adverse events (TEAEs) are reported using exposure-adjusted incidence rates (EAIRs) per 100 patient-years. Trial registration: BE SURE (NCT03412747), BE VIVID (NCT03370133), BE BRIGHT (NCT03598790), BE RADIANT (NCT03536884). Results Rapid and durable improvements in clinical responses and benefits in health-related quality of life were observed among PASI 90 nonresponders who switched to bimekizumab. Most PASI 90 nonresponders achieved PASI 90 4 weeks after switching to bimekizumab from adalimumab (67%), ustekinumab (79%) and secukinumab (53%). After 48 weeks of bimekizumab, 91%, 90% and 79% of PASI 90 nonresponders had achieved PASI 90 after switching from adalimumab, ustekinumab or secukinumab, respectively. Durable improvements were also observed for PASI 100, Investigator's Global Assessment score 0/1, body surface area affected by psoriasis <= 1%, absolute PASI <= 2, and Dermatology Life Quality Index 0/1. Among PASI 90 responders, existing treatment responses were maintained or improved after switching to bimekizumab. The majority of TEAEs were mild or moderate. EAIRs were generally similar between active-comparator treatment periods and after switching to bimekizumab. EAIRs typically decreased with a longer duration of bimekizumab exposure. Conclusions High proportions of patients who did not adequately respond to adalimumab, ustekinumab or secukinumab achieved high levels of skin clearance after switching to bimekizumab. Bimekizumab was well tolerated and there were no new safety findings. For clinicians and for patients with psoriasis to make informed treatment decisions, it is important to assess the efficacy and safety of switching biologics. These analyses demonstrated that after switching to bimekizumab from adalimumab, ustekinumab, or secukinumab, high proportions of patients either achieved or maintained complete and/or near complete skin clearance. Switching to bimekizumab was well tolerated and there were no new safety findings.

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