Bimekizumab Shows Sustained 5-Year Efficacy, Safety in Plaque Psoriasis Patients

In the BE BRIGHT trial, bimekizumab demonstrated high rates of clinical and health-related quality of life responses across 5 years in US and Canadian patients with moderate to severe plaque psoriasis. This study, led by Andrew Blauvelt, MD, from Blauvelt Consulting in Annapolis, Maryland, was presented at the 2025 Society of Dermatology annual summer meeting in Washington, DC, from June 25 to June 29th.

This data adds to the pooled analysis of phase 3 trials BE SURE, BE VIVID, BE READY, and BE BRIGHT, which showed that participants on bimekizumab achieved complete skin clearance, indicated by a Psoriasis Area and Severity Index (PASI) 100 by week 16.

BE BRIGHT, a 144-week extension of the phase 3 trials BE VIVID (52 weeks) and BE SURE (56 weeks), had 2 parts: the first open-label extension (OLE) and a second 48-week extension (OLE2). Patients entered BE BRIGHT OLE2 with or without a treatment break; those who got a break had completed the study before it was extended. This analysis included patients randomized to bimekizumab 320 mg at baseline who continuously received bimekizumab in OLE2, with no treatment break. All patients received bimekizumab every 8 weeks during OLE2.

The sample (n = 153), with a mean age of 45.7 years, had 66.7% males, 81% White participants, a mean baseline PASI of 19.7, and a mean baseline BSA of 24.4. More than half (65.4%) had prior systemic therapy, and 30.7% had prior biologic therapy, including anti-TNF (15.7%), anti-IL-17 (11.8%), anti-IL-23 (2.6%), and anti-IL-12/23 (5.2%). The mean duration of psoriasis was 19 years.

The analysis reported 5-year efficacy and safety data for bimekizumab treatment, up to OLE2 week 48, which was 244 or 248 weeks of total treatment.

At year 1 (week 52), 92.8% of patients on bimekizumab achieved 90% improvement in Psoriasis and Severity Index (PASI 90). At year 5 (week 244), 84.9% on bimekizumab achieved PASI 90.

Among the subgroup of patients who received bimekizumab every 4 weeks up to week 16 and then every 8 weeks thereafter (n = 52), 96.2% and 88.5% of patients achieved PASI 90, respectively.

As for the percentage of patients reaching remission, 75.2% and 67.7% of patients on bimekizumab at year 1 and 5 achieved 100% improvement in the PASI (PASI 100). In total, 78.8% and 76.9% of patients who received bimekizumab every 4 weeks then every 8 weeks, respectively, achieved PASI 100.

Investigator’s Global Assessment 0/1 achievement rates showed a similar trend to the scores of the PASI 90. Dermatology Life Quality Index 0/1 achievement rates were similar at year 1 and 5 for patients on bimekizumab but numerically greater for patients receiving bimekizumab for 4 weeks then 8 weeks at year 5 versus year 1.

Over 5 years, there were low reports of serious treatment-related adverse events (TEAEs) (3.6) and discontinuations due to TEAEs (0). The most common TEAEs included nasopharyngitis, oral candidiasis, coronavirus infection, and upper respiratory tract infection, with no new TEAEs identified.

Most events of oral candidiasis (99.3%) were mild to moderate, and none led to discontinuation.

Other TEAs included serious injections, active tuberculosis, fungal infections, definite or probable adjudicated IBD, adjudicated MACE, malignancies, excluding NMSC, adjusted SIB, neutropenia, ALT or AST >3x ULN, ALT or AST >5x ULNc, serious hypersensitivity reaction, and injection site reactions.

Patients who took bimekizumab every 4 weeks and then every 8 weeks had similar safety findings. However, the investigators noted that this sample was small, so results should be viewed with caution.

“Bimekizumab demonstrated high rates of clinical and health-related quality of life responses, which were highly durable to Year 5, in patients from the US and Canada with moderate to severe plaque psoriasis,” investigators concluded. “Bimekizumab was well-tolerated in this patient subgroup, with no unexpected safety findings.”

References

1. Blauvelt A, Khattri S, Rich P, et al. Bimekizumab efficacy and safety through 5 years in patients with moderate to severe plaque psoriasis in the US and Canada. Presented at SDPA 2025 from June 25 – 29th in Washington, DC

2. Derman, C. Bimekizumab Shows Long-Term Psoriasis Skin Clearance in 4-Year Phase 3 Data. HCPLive. June 27, 2025. https://www.hcplive.com/view/bimekizumab-shows-long-term-psoriasis-skin-clearance-in-4-year-phase-3-data. Accessed June 29, 2025.