Synopsis Objective To determine whether increased disease control in psoriasis with treatment translates into improvements in quality of life. Methods Patients reaching different absolute PASI thresholds were assessed for simultaneous achievement of DLQI 0/1. Results Week 52 Conclusion Patients treated with bimekizumab more frequently achieved PASI≤2 by Week 52, with the majority of these patients also achieving DLQI 0/1. Objective To examine how improved disease control translates to greater quality of life in patients with moderate to severe plaque psoriasis receiving bimekizumab compared with ustekinumab and placebo. Background • Psoriasis negatively impacts patients’ quality of life,1 and therefore it is important to determine whether improvements in disease control achieved with treatment may also be reflected in greater quality of life. • Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, both of which have a pivotal role in psoriasis immunopathogenesis.2-5 • Absolute Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) were assessed in patients with moderate to severe plaque psoriasis being treated with bimekizumab versus (vs) ustekinumab and placebo. Methods • In BE VIVID (NCT03370133) patients were randomized to bimekizumab through Week 52, ustekinumab through Week 52 or placebo; patients randomized to placebo switched to bimekizumab at Week 16 (Figure 1). • Psoriasis severity was assessed by PASI, where PASI=0 indicated complete skin clearance and PASI≤2, a relevant disease endpoint for a treat to target approach in psoriasis,6 indicated disease control. • Patients completed the DLQI questionnaire throughout treatment; DLQI of 0 or 1 indicated no impact on quality of life.7 • To evaluate how clinical response translates into health-related quality of life in these post hoc analyses, patients achieving DLQI 0/1 were grouped by PASI=0, PASI≤2, 2100 kg at baseline received two ustekinumab 45 mg injections; bBE BRIGHT: NCT03598790. Table 1 Baseline characteristics aBimekizumab dosing was 320 mg regardless of weight, while ustekinumab dosing was based on weight: patients ≤100 kg at baseline received one ustekinumab 45 mg injection and one placebo injection, patients >100 kg at baseline received two ustekinumab 45 mg injections; bIn each treatment group, one patient with mild IGA score was mistakenly enrolled. Figure 2 Simultaneous achievement of PASI=0 and DLQI 0/1 at Weeks 16 and 52 (OC)a N numbers represent the number of patients with both a PASI and DLQI assessment at that time point. aPatients randomized to placebo not shown. aWeek 52 data not shown for patients randomized to placebo as they switched to bimekizumab treatment at Week 16. Denominators used represent the number of patients in that treatment group with an assessment at that time point for each type of measure (PASI or DLQI). Of all patients, 283 randomized to bimekizumab, 141 to ustekinumab and 69 to placebo completed the study to Week 52. Table 2 Number (%) of patients achieving absolute PASI scores and DLQI 0/1 (OC) Bimekizumab 320 mg Q4W (n=321)a Ustekinumab 45/90 mg Q12W (n=163)a Placebo (n=83) Age (years), mean ± SD 45.2 ± 14.0 46.0 ± 13.6 49.7 ± 13.6 Male, n (%) 229 (71.3) 117 (71.8) 60 (72.3) Caucasian, n (%) 237 (73.8) 120 (73.6) 63 (75.9) Weight (kg), mean ± SD 88.7 ± 23.1 87.2 ± 21.1 89.1 ± 26.4 Duration of psoriasis (years), mean ± SD 16.0 ± 11.6 17.8 ± 11.6 19.7 ± 13.8 PASI, mean ± SD 22.0 ± 8.6 21.3 ± 8.3 20.1 (6.8) BSA (%), mean ± SD 29.0 ± 17.1 27.3 ± 16.7 27.0 ± 16.3 IGA, n (%)b 3: moderate 201 (62.6) 96 (58.9) 54 (65.1) 4: severe 119 (37.1) 66 (40.5) 28 (33.7) DLQI total, mean ± SD 9.9 ± 6.3 11.0 ± 6.9 10.0 ± 6.8 Any prior systemic therapy, n (%) 267 (83.2) 132 (81.0) 64 (77.1) Prior biologic therapy, n (%) 125 (38.9) 63 (38.7) 33 (39.8) Absolute PASI DLQI 0/1 PASI=0 PASI≤2 W e e k 4 Bimekizumab 48/318 (15.1) 148/318 (46.5) 120/320 (37.5) Ustekinumab 2/161 (1.2) 10/161 (6.2) 18/161 (11.2) Placebo 2/81 (2.5) 2/81 (2.5) 5/80 (6.3) W e e k 1 6 Bimekizumab 188/307 (61.2) 273/307 (88.9) 216/308 (70.1) Ustekinumab 35/156 (22.4) 84/156 (53.8) 69/156 (44.2) Placebo 0/76 (0.0) 3/76 (3.9) 10/76 (13.2) W e e k 5 2 a Bimekizumab 207/277 (74.7) 263/277 (94.9) 240/277 (86.6) Ustekinumab 63/139 (45.3) 98/139 (70.5) 103/141 (73.0) 80% 60% 40% 20% 100% 0% Bimekizumab Ustekinumab PASI≤2 only PASI≤2 + DLQI 0/1 70.5% 94.9% 59.7% 83.8% n=321 n=163 n=83 Week 16Baseline Week 52 2–5 weeks Bimekizumab 320 mg Q4Wa Bimekizumab 320 mg Q4WaPlacebo Ustekinumab 45/90 mg Q12Wa 20 weeks after last dose: safety follow-up Open-label extension study (BE BRIGHT)b Screening Initial treatment period Active comparator period Maintenance period 4:1:2 randomization N=567 Ustekinumab Bimekizumab Bimekizumab Week 16 Week 52 Ustekinumab PASI=0: PASI=0 and DLQI 0/1: Bimekizumab Ustekinumab 61.2% 74.7% 45.3% n=307 n=277 n=156 n=139 44.6% 68.6% 17.3% 40.3% 22.4% Figure 3 Simultaneous achievement of PASI≤2 and DLQI 0/1 at Weeks 16 and 52 (OC)a N numbers represent the number of patients with both a PASI and DLQI assessment at that time point. aPatients randomized to placebo not shown. Ustekinumab Bimekizumab PASI≤2: PASI≤2 and DLQI 0/1: Bimekizumab Ustekinumab Bimekizumab Week 16 Week 52 Ustekinumab n=307 n=277 n=156 n=139 88.9% 83.8% 94.9% 34.6% 59.7% 70.5% 53.8% 65.1%