Bimekizumab Durability of High-Level Clinical and Quality of Life Responses in Early Responders with Moderate to Severe Plaque Psoriasis: 4-Year Results from Four Phase 3 Trials

Abstract

Introduction Bimekizumab (BKZ) has demonstrated rapid, sustained efficacy in moderate to severe plaque psoriasis, with many patients achieving skin responses at Week (Wk)4, after one dose.¹ While early clinical response is important to patients, as demonstrated using a cross-sectional survey by Gorelick et al., disease chronicity makes long-term durability crucial for both patients and clinicians.^2,3 Here, we examine the maintenance of clinical and quality of life (QoL) outcomes over 4 years (yrs) in patients achieving early skin responses with BKZ.

Procedure/study Data were pooled from the 52/56-wk phase 3 trials BE VIVID/BE SURE/BE READY and their 144-wk open-label extension (OLE), BE BRIGHT.^1,4–7 Patients received BKZ 320mg every 4 wks (Q4W) to Wk16, then BKZ Q4W or Q8W into the OLE (BKZ Total). All received BKZ Q8W from OLE Wk100/104 or next scheduled visit. A subgroup received BKZ Q4W to Wk16 then Q8W thereafter (BKZ Q4W/Q8W; approved dosing regimen for most patients with psoriasis).⁸ Maintenance of ≥75/≥90/100% improvement in Psoriasis Area and Severity Index (PASI 75/90/100) and Dermatology Life Quality Index (DLQI) 0/1 was assessed through Wk196/200 (Yr4) in Wk4 PASI 75/90 responders. Patients discontinuing treatment due to lack of efficacy/treatment-related adverse events were considered non-responders at subsequent timepoints; multiple imputation was used for all other missing data.

Results Overall, 771 patients received BKZ continuously and entered the OLE (BKZ Total); 592 (76.8%)/331 (42.9%) were Wk4 PASI 75/90 responders (BKZ Q4W/Q8W [N=197]: 158 [80.2%]/79 [40.1%]). Baseline characteristics were similar between Wk4 PASI 75/90 responders and the overall population. In the BKZ Total group, 95.3% of Wk4 PASI 75 responders maintained PASI 75 to Yr4. In BKZ Total Wk4 PASI 75 responders, PASI 90/PASI 100/DLQI 0/1 responses increased from Wk4 (55.9%/20.8%/41.3%) to Wk16 (95.2%/71.3%/73.6%) and were maintained to Yr4 (87.6%/67.5%/78.6%). Among BKZ Total Wk4 PASI 90 responders, 95.6%/89.2% maintained PASI 75/90 responses to Yr4. In Wk4 PASI 90 responders, PASI 100/DLQI 0/1 responses increased from Wk4 (37.2%/49.7%) to Wk16 (79.7%/79.4%) and were maintained to Yr4 (73.2%/80.7%). Responses were similar in the BKZ Q4W/Q8W subgroup.

Conclusion Patients with early skin improvement after 4 wks of bimekizumab maintained or improved high skin and QoL responses through 4 yrs, providing insight for clinicians and patients that bimekizumab may provide both rapid and durable psoriasis disease control.