Bimekizumab Remission and High Disease Control Over 4 years in Patients with Psoriasis Achieving Complete Skin Clearance at Week 16: Results from Four Phase 3 Trials

Abstract

Introduction Long-term maintenance of high efficacy levels in patients with psoriasis is important.¹ Here, maintenance of remission of psoriasis or high disease control, allowing for up to 4 visits with lower, yet still favorable, responses are reported over 4 years in patients who achieve complete skin clearance after 16 weeks of bimekizumab (BKZ) treatment.

Procedure Data were pooled from the 52-week BE VIVID (NCT03370133) and 56-week BE SURE (NCT03412747) and BE READY (NCT03410992) phase 3 trials, and their 144-week open-label extension (OLE) BE BRIGHT (NCT03598790).^2–5 Included patients received BKZ 320 mg every 4 weeks (Q4W) to Week 16, then Q4W or Q8W into the OLE; all patients received BKZ Q8W from Week 100/104 (OLE Week 48) or the next scheduled visit. Data are reported for patients who received continuous BKZ and entered the OLE, regardless of dosing regimen (BKZ Total), and for the subset who received BKZ Q4W to Week 16 then Q8W continuously thereafter (Q4W/Q8W; approved dosing regimen for most patients with psoriasis).⁶ Percentages of patients achieving PASI 0 at Week 16 who maintained PASI 0 at every subsequent study visit from Week 16–Year 4 (Week 196/200; 29/30 further visits [study-dependent]) are reported. Percentages of patients who maintained PASI 0 at every visit except up to 2/3/4 visits with PASI >0–≤2 (referred to here as remission) are also reported. Percentages of patients who maintained BSA ≤1%/PASI ≤2 at every study visit, and allowing for up to 2/3/4 visits with BSA >1%–≤3%/PASI >2–≤5 (referred to here as high disease control), are also presented. Thresholds were chosen based on target outcomes defined in treatment guidelines.^7,8 Patients who discontinued treatment due to lack of efficacy/treatment-related adverse events were considered non-responders at subsequent timepoints; last observation carried forward was used for other missing data (mNRI-LOCF).

Results Among Week 16 PASI 0 responders who entered the OLE (BKZ Total; N=503), 48.9% maintained PASI 0 at every visit from Week 16 to Year 4; 65.0%/68.6%/72.0% maintained PASI 0 at every visit except up to 2/3/4 visits with PASI >0–≤2. Additionally, 81.3% of Week 16 PASI 0 responders maintained PASI ≤2 at every visit to Year 4; 90.1%/91.5%/91.8% maintained PASI ≤2 at every visit except up to 2/3/4 visits with PASI >2–≤5. PASI results were consistent in the BKZ Q4W/Q8W group. Among Week 16 PASI 0 responders, 69.4% maintained BSA ≤1% at every visit to Year 4; 80.3%/81.1%/81.7% maintained BSA ≤1% at every visit except up to 2/3/4 visits with BSA >1%–≤3%. In the BKZ Q4W/Q8W group (N=147), 68.7% maintained BSA ≤1% at every visit; 81.6%/82.3%/83.0% maintained BSA ≤1% at every visit except up to 2/3/4 visits with BSA >1%–≤3%.

Conclusion High percentages of bimekizumab-treated Week 16 PASI 0 responders maintained remission or high disease control through 4 years.