Long-term bimekizumab delivers durable efficacy in moderate-to-severe plaque psoriasis

Treatment with bimekizumab for 4 years results in satisfactory levels of clinical and health-related quality of life responses, reports a study. The majority of patients with moderate-to-severe plaque psoriasis achieve near-complete skin clearance, while nearly two-thirds have complete skin clearance.

Furthermore, “[b]imekizumab was well-tolerated, as indicated by low rates of discontinuations due to treatment-emergent adverse events (TEAEs),” the researchers said. 

"TEAE rates did not increase with longer exposure to bimekizumab, and safety data were consistent with bimekizumab's known safety profile,” they added.

This study pooled data from three phase III trials (ie, BE VIVID, BE READY, and BE SURE) as well as their open-label extension (OLE; ie, BE BRIGHT). The researchers reported efficacy for patients treated with bimekizumab continuously from baseline to the OLE and safety for those who received ≥1 dose.

Overall, 771 patients received bimekizumab from baseline into the OLE. With regard to efficacy, a significant number of patients attained complete skin clearance (100-percent improvement from baseline in Psoriasis Area and Severity Index) at week 52 (76.2 percent) and maintained this through week 196 (64.7 percent). [J Am Acad Dermatol 2025;93:644-653]

In terms of safety, longer exposure to the study drug did not increase, with a 4-year TEAE rate of 169.8 per 100 patient-years (n=1,495). The most frequent TEAEs were nasopharyngitis, oral candidiasis, and upper respiratory tract infection. This is consistent with the known safety profile of bimekizumab.

“These results demonstrate that bimekizumab is an effective long-term treatment option for patients with moderate-to-severe plaque psoriasis,” the researchers said.

Liver parameters

Notably, longer exposure to bimekizumab did not lead to elevated rates of liver transaminase elevations, the occurrences of which were transient and rarely prompted treatment cessation. This finding supported that of a previous study on liver parameters. [J Am Acad Dermatol 2024;91:281-289]

Likewise, 4-year rates of suicidal ideation and behaviour were low at 0.1 per 100 person-years, which aligned with a previous study across nine trials. [J Am Acad Dermatol 2024;91:72-81]

Malignancies and adjudicated major adverse cardiac events (0.6 per 100 person-years) were also rare throughout the treatment duration and within Psoriasis Longitudinal Assessment and Registry ranges. [J Drugs Dermatol 2015;14:706-714; J Drugs Dermatol 2020;19:571-572]

In addition, the 4-year rate of definite or probable adjudicated inflammatory bowel disease was 0.2 per 100 person-years. Longer exposure to bimekizumab did not increase the annual rates.

“These analyses include data from the patient subgroup who received the bimekizumab dosing regimen approved for most patients with psoriasis, providing important supporting evidence for this regimen, which is now used in real-world clinical settings,” the researchers said. [https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf; https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761151s000lbl.pdf] 

“However, this subgroup contained a smaller number of patients, so variability in results can be expected,” they added.

Of note, generalizability of the current findings to real-world populations is limited due to the eligibility criteria and minimal racial diversity within the trials.