Efficacy and Safety of Bimekizumab in Patients with Moderate to Severe Plaque Psoriasis: Results from BE READY, a 56-Week Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study with Randomized Withdrawal

ConclusionsHigh levels of skin clearance were observed with bimekizumab after one dose and at Week 16, compared with placebo.Clinical responses were durable through 56 weeks, regardless of bimekizumab dosing schedule.Bimekizumab was well-tolerated and the safety profile was consistent with previous studies.4-7 Objectives To compare the efficacy and safety of bimekizumab with placebo over 16 weeks in patients with plaque psoriasis, and evaluate the effect of randomized treatment withdrawal, compared with continued treatment, in Week 16 responders. BackgroundBimekizumab is a monoclonal IgG1 antibody that has been rationally designed to selectively inhibit IL-17F in addition to IL-17A.1,2 Both of these interleukins are implicated in the immunopathogenesis of plaque psoriasis (PSO).3 Bimekizumab led to substantial clinical improvements in patients with moderate to severe PSO in the phase 2 BE ABLE study (NCT02905006, NCT03010527), with no unexpected safety findings.4,5 Methods Adult patients with moderate to severe PSO were enrolled in the pivotal phase 3 BE READY study (NCT03410992), which incorporated a 16-week randomized, double-blinded, placebo-controlled period followed by a 40-week randomized withdrawal period (Figure 1).• The co-primary endpoints were a 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) and an Investigator's Global Assessment score of 0 or 1 (IGA 0/1) at Week 16.Secondary endpoints included PASI 100 at Week 16 and PASI 75 at Week 4. Other endpoints included PASI 75, PASI 90, and PASI 100 at other timepoints.• 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• Co-primary endpoints of PASI 90 and IGA 0/1 at Week 16 were achieved by 90.8% and 92.6% of bimekizumab-treated patients, respectively, compared with 1.2% and 1.2% in the placebo group, respectively (p<0.001 for both).• Response was rapid, with over 75% of bimekizumab-treated patients achieving PASI 75 at Week 4, after just one dose (Figure 2).• PASI 90 response was well-maintained in patients re-randomized to bimekizumab, regardless of dosing schedule (Figure 3).• Among patients re-randomized to placebo, loss of response was slow; median time to relapse (loss of PASI 75 response following re-randomization was ~28 weeks (~32 weeks from last bimekizumab dose). Safety• Overall, bimekizumab was well-tolerated; discontinuation due to TEAEs was low, and there were no deaths in the study (Table 2).• All cases of oral candidiasis were localized, mild, or moderate superficial infections, and no cases led to discontinuation (Table 2).The most common TEAEs with bimekizumab were nasopharyngitis, oral candidiasis, and upper respiratory tract infection.

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