2374: Bimekizumab Efficacy And Safety Through 5 Years In Patients With Moderate To Severe Plaque Psoriasis In The US And Canada

Background/Purpose: Given the chronic nature of psoriasis, and the loss of response observed with biologic therapies over time, it is crucial to establish the long-term efficacy and safety of biologic therapies for psoriasis. Here, we evaluate the efficacy and safety of bimekizumab (BKZ) treatment through 5 years in patients with moderate to severe plaque psoriasis from the US and Canada.

Methods: A US/Canadian patient subgroup completing the BE VIVID (NCT03370133)/BE SURE (NCT03412747)/BE READY (NCT03410992) phase 3 trials and their open-label extension (OLE), BE BRIGHT (NCT03598790; 4 years’ total treatment) could enter a second 48-week extension (OLE2), in which they received BKZ 320 mg every 4 weeks (Q4W) or Q8W depending on Investigator’s Global Assessment (IGA) response at entry.^1–4 Included patients received BKZ continuously from feeder study baseline to OLE2 entry; patients receiving BKZ Q4W to Week 16 then Q8W thereafter (BKZ Q4W/Q8W; approved dosing regimen) were also analyzed.⁵

Five-year efficacy data are reported (244 weeks’ total treatment). Patients discontinuing treatment due to lack of efficacy/treatment‑related adverse events were considered non-responders; multiple imputation was used for other missing data (modified non‑responder imputation). Treatment-emergent adverse events (TEAEs) are reported through 5 years (Weeks 0–244) using exposure-adjusted incidence rates/100 patient-years [PY]).

Results: In total, 153 US/Canadian patients were analyzed; 52 received BKZ Q4W/Q8W.

At Year 1 (Week 52) and Year 5 (Week 244), 75.2% and 67.7% patients treated with BKZ achieved 100% improvement from baseline in Psoriasis Area and Severity Index (PASI 100), respectively (BKZ Q4W/Q8W: 78.8% and 76.9%). At Year 1 and Year 5, 92.8% and 84.9% achieved PASI 90 (BKZ Q4W/Q8W: 96.2% and 88.5%).

Over 5 years, serious TEAEs (3.6/100 PY) and discontinuations due to TEAEs (0.3/100 PY) were low; zero deaths occurred. Most common TEAEs were nasopharyngitis (9.7/100 PY), oral candidiasis (7.6/100 PY), and corona virus infection (6.1/100 PY). The vast majority (99.3%) of oral candidiasis events were mild/moderate; none led to discontinuation. Safety results were generally similar in BKZ Q4W/Q8W patients.

Conclusion: BKZ demonstrated high rates of clinical response, which were durable over 5 years, in patients from the US and Canada with moderate to severe plaque psoriasis. BKZ was well-tolerated in this patient subgroup, with no unexpected safety findings.



References: 1. Reich K. Lancet 2021;397:487–98; 2. Warren RB. N Engl J Med 2021;385:130–41; 3. Gordon KB. Lancet 2021;397:475–86; 4. Strober B. Br J Dermatol 2023;188:749–59; 5. Bimekizumab Summary of Product Characteristics. 2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761151s000lbl.pdf [Accessed April 2025].

Previously presented at AAD 2025.