Bimekizumab response maintenance through two years of treatment in patients with moderate to severe plaque psoriasis who responded after 16 weeks: Interim results from the BE BRIGHT open-label extension trial

ObjectiveEvaluate maintenance of response rates among patients with moderate to severe plaque psoriasis receiving BKZ who had an initial response (IGA 0/1, BSA ≤1%, PASI 100) at Week 16 of the three phase 3 feeder studies and received continuous Q4W or Q8W BKZ maintenance dosing over two years.• In phase 3 clinical trials, BKZ led to substantial clinical improvements in patients with moderate to severe plaque psoriasis, with no unexpected safety findings.[2][3][4][5] • Given that psoriasis is a chronic disease, it is important to understand long-term treatment efficacy. Methods• Patients who completed one of three phase 3 studies (BE VIVID: NCT03370133; BE SURE: NCT03412747; BE READY: NCT03410992) could enroll in the BE BRIGHT (NCT03598790) twoyear open-label extension (OLE).[1][2][3] These analyses include patients randomized to BKZ 320 mg every 4 weeks (Q4W) who responded at Week 16 of the feeder study, received BKZ 320 mg Q4W or every 8 weeks (Q8W) maintenance dosing from Week 16, and enrolled in BE BRIGHT (Figure 1).• We report maintenance of Investigator's Global Assessment (IGA) 0/1, psoriasis body surface area (BSA) ≤1%, and 100% improvement in the Psoriasis Area and Severity Index (PASI 100, complete skin clearance) through two years of treatment (OLE Week 48) among Week 16 responders who received continuous BKZ maintenance dosing in the OLE (Q4W/Q4W/Q4W or Q4W/Q8W/Q8W).• Missing data were imputed using modified non-responder imputation (mNRI), non-responder imputation (NRI), and observed case (OC).-mNRI: Multiple imputation was used for missing data, except for patients with missing data following treatment discontinuation due to lack of efficacy where they were considered non-responders.• Safety over two years was evaluated for all patients who received ≥1 dose of BKZ in the phase 3 feeder studies or the OLE.-Treatment-emergent adverse events (TEAEs) were coded using MedDRA v19.0.Exposure-adjusted incidence rates (EAIRs) are the incidence of new cases per 100 patient-years (PY). Results• Patient demographics and baseline characteristics for Week 16 responders are reported in Table 1.• 989 patients were initially randomized to BKZ 320 mg Q4W; at Week 16, 87.5% achieved IGA 0/1, 74.9% achieved BSA ≤1%, and 62.7% achieved PASI 100 (NRI).• Among Week 16 IGA 0/1, BSA ≤1%, and PASI 100 responders, respectively, response rates were maintained to OLE Week 48 with both Q4W and Q8W maintenance dosing regimens (Figure 2).• The most common TEAEs (incidence >5%) were nasopharyngitis, oral candidiasis, and upper respiratory tract infection.No new safety signals were identified in the phase 3 feeder studies or the BE BRIGHT OLE (Table 2).

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