Efficacy and Safety of Bimekizumab in Patients with Moderate to Severe Plaque Psoriasis: Results from BE VIVID, a 52-Week Phase 3, Randomized, Double-Blinded, Ustekinumab- and Placebo-Controlled Study

ConclusionsSuperior PASI 90 and IGA 0/1 responses were observed with bimekizumab compared with ustekinumab at Week 16.After one dose, faster onset of response was observed with bimekizumab compared with ustekinumab.Clinical responses with bimekizumab were durable through Week 52.Bimekizumab was well-tolerated and the safety profile was consistent with previous studies.4,5,9,10 Objectives To compare the efficacy and safety of bimekizumab with ustekinumab and placebo in patients with moderate to severe plaque psoriasis treated for one year. BackgroundBimekizumab is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A.Both of these interleukins are implicated in the immunopathogenesis of psoriasis.1-3 Bimekizumab led to substantial clinical improvements in patients with moderate to severe plaque psoriasis (PSO) in the phase 2 BE ABLE study, with no unexpected safety findings.4,5 Methods Adult patients with moderate to severe PSO were enrolled in the pivotal phase 3 BE VIVID study (NCT03370133), a randomized, double-blinded superiority study in which patients were treated with bimekizumab, ustekinumab, or placebo (Figure 1).• The co-primary endpoints were superiority of bimekizumab versus placebo in 90% improvements from baseline in Psoriasis Area and Severity Index (PASI 90) and an Investigator's Global Assessment score of 0 or 1 (IGA 0/1).• Missing data were imputed with non-responder imputation (NRI).• Treatment emergent adverse events (TEAEs) were classified using MedDRA version 19.0. Results Patient Population• Baseline characteristics are shown in Table 1. Efficacy• At Week 16, the proportions of patients receiving bimekizumab who achieved PASI 90 and IGA 0/1 were significantly greater than for ustekinumab or placebo (Figure 2).• Response was rapid, with 76.9% of bimekizumab-treated patients achieving PASI 75 at Week 4, compared to 15.3% for ustekinumab and 2.4% for placebo (p<0.001vs ustekinumab and placebo). Safety• Overall, bimekizumab was well-tolerated and discontinuation due to TEAEs was low (Table 2).• The vast majority of the oral candidiasis cases were localized, mild or moderate superficial infections, and did not lead to discontinuation (Table 2).• All incidences of major adverse cardiac events (MACE) occurred in patients with ≥2 pre-existing cardiovascular risk factors (Table 2).• Overall incidence of MACE across the bimekizumab in PSO clinical program (phase 2/phase 3/open-label extension to Nov 1, 2019) was 0.66/100 patient-years and consistent with the background risk within the PSO population and incidence for other anti-IL biologics.6-8

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