Bimekizumab Clinical Efficacy in Important Body Regions and Health-related Quality of Life in Patients with Plaque Psoriasis: Data from Four Phase 3/3b Comparator-controlled Trial Periods

Psoriasis affecting certain 'high-impact' areas, such as the scalp, nails, palms, and soles, can have a large impact on health-related quality of life (HRQoL).1,2 • In addition, psoriasis can have a different impact on patient HRQoL depending on the body regions it affects (head/neck, trunk, arms, legs).1-3 Objective To examine how achievement of complete skin clearance in various body regions and high-impact areas translates into HRQoL benefits perceived by patients treated with bimekizumab (BKZ) vs comparators.Methods • Data were analyzed from patients with moderate to severe plaque psoriasis who received BKZ 320 mg every 4 weeks (Q4W), or BKZ Q4W to Week 16 followed by every 8 weeks (Q8W), vs those who received comparators during controlled periods of four phase 3/3b trials: pooled BE VIVID/BE READY (BKZ vs placebo [PBO] to Week 16), 4,5 BE SURE (BKZ vs adalimumab [ADA] to Week 24), 6 BE RADIANT (BKZ vs secukinumab [SEC] to Week 48), 7 and BE VIVID (BKZ vs ustekinumab [UST] to Week 52). 4• Proportions of patients who achieved the following outcomes concurrently with Dermatology Life Quality Index (DLQI) 0/1 (no effect of skin disease on patient's life) are reported: body region-specific PASI 100 (100% improvement from baseline in Psoriasis Area and Severity Index [PASI] for head/neck, trunk, arms, and legs), and scalp Investigator's Global Assessment (IGA) 0, modified Nail Psoriasis Severity Index (mNAPSI) 0, and palmoplantar IGA 0 (complete scalp/nail/palmoplantar clearance).• Included patients had PASI >0 for the relevant PASI body region, scalp IGA ≥3, mNAPSI >10, or palmoplantar IGA ≥3 at baseline.Data are reported using non-responder imputation (NRI). Results• Pooled across BE VIVID/BE READY, 670 patients were randomized to BKZ and 169 to PBO.In BE SURE, 319 were randomized to BKZ and 159 to ADA.In BE RADIANT, 373 were randomized to BKZ and 370 to SEC.In BE VIVID only, 321 were randomized to BKZ and 163 to UST. PASI body region clearance and DLQI 0/1• In each study at Week 4 (after a single dose of BKZ), a greater proportion of BKZ-randomized patients achieved PASI 100 across each body region vs all comparators (Figure 1).• Concurrent PASI 100 and DLQI 0/1 achievement for each body region was greater in BKZ-randomized patients at Week 4 vs comparators (Figure 1).• These proportions increased through the end of comparator-controlled periods, remaining greater in BKZ-randomized patients vs comparators for each body region (Figure 1).Proportions were similar across body regions with BKZ by the end of controlled periods. High-impact area clearance and DLQI 0/1• A greater proportion of BKZ-randomized patients achieved palmoplantar IGA 0 and scalp IGA 0 vs comparators at each time point (Table 1, Figure 2; although some patient groups with palmoplantar involvement were small).• While few patients in any study achieved mNAPSI 0 at Week 4, reflecting the longer time taken for nails to grow, greater proportions of BKZ-vs comparator-treated patients achieved mNAPSI 0 at the end of controlled periods (Figure 2).• Similarly, across studies, greater proportions of BKZ-randomized patients achieved concurrent scalp IGA 0/palmoplantar IGA 0 and DLQI 0/1 at Week 4 vs comparators (Table 1).At the end of comparator-controlled periods, for each high-impact area, greater proportions of BKZ-randomized patients achieved concurrent clearance and DLQI 0/1 vs comparators (Figure 2). ConclusionsBimekizumab-treated patients experienced higher clinical responses in the scalp, nails, palms and soles, and each PASI body region compared to placebo, adalimumab, secukinumab, and ustekinumab in comparator-controlled studies, which translated concurrently into numerically greater patient-perceived HRQoL benefits.

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