Study Finds Bimekizumab Improves Genital, Scalp, Nail Psoriasis at 52 Weeks

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Bimekizumab treatment of scalp, genital, and nail psoriasis is effective for patients, according to new findings, with improvements of in Dermatology Life Quality Index (DLQI) scores at the 52-week mark.¹

These data resulted from new research authored in part by Teppei Hagino, MD, PhD, from the Nippon Medical School Chiba Hokusoh Hospital department of dermatology in Japan. Bimekizumab itself is a humanized monoclonal immunoglobulin G1 antibody which was formulated to impact interleukin (IL)-17A as well as IL-17F.

“Clinical trials have shown its high efficacy in treating psoriasis; however, real-world data on its long-term effectiveness, especially in difficult-to-treat areas like the genital region, scalp, and nails, remains limited,” Hagino and colleagues wrote.^1,2

Consequently, this new analysis by Hagino et al. was conducted with the aim of assessing the medication’s real-world effectiveness, specifically over the course of a 52-week period among individuals with psoriasis located in the genital region, nails, and scalp.

Background and Trial Design

The investigative team conducted their research in the period between May 2022 - August 2024, assessing the efficacy of bimekizumab among 62 adults known to have moderate-to-severe psoriasis. The study’s treatment period involved 320 mg bimekizumab administered subcutaneously on a basis of every 4 weeks up to the 16-week mark.

This would then be followed by either every 4 week dosing among 25 individuals or every 8 weeks among 37 individuals, based on subjects’ clinical responses to the treatment. The team highlighted that in the beginning of their analysis, participants’ average age was shown to be 55.8 years, and 72.6% were male.

The researchers noted that the subjects’ mean Psoriasis Severity Index score had been 9.6 (±9.2), indicating moderate to severe disease severity. Overall, the investigators’ work involved evaluating 33 subjects shown to have plaque psoriasis, 25 shown to have psoriatic arthritis, and 4 who have erythrodermic psoriasis, all of whom had been given treatment for 4 weeks minimum.

There were no other medications to be used concurrently. All study subjects were treated exclusively with bimekizumab monotherapy, with the investigators assessing the severity of psoriasis impacting the nails, genitals, and scalp at the 0, 4, 16, 24, 40, and 52-week marks using site-specific Physician's Global Assessment (PGA) tools.

The research team’s tools for evaluation included the fingernail PGA (PGA-F), the genital-specific PGA (PGA-G), and scalp-specific PGA (ss-PGA). They rated severity of lesions on a 5-point scale ranging from 0 - 4, indicating a clear score for the 0 and severe for 4.

For participants with baseline site-specific PGA scores of 2 or higher, the investigators assessed the rates of PGA score achievement of 0 or 1 (clear or almost clear) with a minimum 2-point improvement from the point of baseline at several different time points throughout their research.

Notable Findings on Bimekizumab

The research team found that over the 52 weeks of subcutaneous bimekizumab treatment, a notable increase was identified in subjects' scores of 0 and 1, in addition to there being a reduction in scores of 3 and 4, across various measures including PGA-F, PGA-G, ss-PGA, and DLQI.

For the 36 individuals showing a baseline PGA-G score of 2 or higher, it was found that 97.0% successfully achieved a genital PGA-G score of 0 or 1 by the 16-week mark. Additionally, 95.7% succeeded at this level by the 52-week mark.

Similarly, the investigative team found that 58.8% of subjects showing a baseline PGA-F score of 2 or greater succeeded in achieving a PGA-F score of 0 or 1 at the 16-week mark. An increase to 78.6% was noted by the 52-week mark.

Among the 56 individuals with an initial ss-PGA score of 2 or greater, the research team noted that 98.0% attained an ss-PGA score of 0 or 1 at 16 weeks, adding that there had been a somewhat lower but still notably significant 97.2% who achieved this milestone by the 52-week mark.

Correspondingly, DLQI-related improvements were also reported by the team, with the percentage of those achieving a DLQI score of 0 or of 1 rising to 75.6% at the 16-week mark. It rose to 87.9% by the 52-week mark.

Comparable clinical improvements were also observed by the investigators in both subjects with and without psoriatic arthritis.

“In conclusion, bimekizumab treatment showed high effectiveness on psoriasis in the genital region, scalp, and nails together with the improvement of DLQI for 52 weeks in real-world practice,” they wrote. “This study provides valuable data of long-term treatment outcomes on psoriasis at the difficult-to-treat areas, supporting the usefulness of bimekizumab in real-world practice.”¹

References

1. ^{Hagino T, Saeki H, Fujimoto E, Kanda N. Bimekizumab for the treatment of genital, scalp, and nail psoriasis: A 52-week real-world study. J Dermatol. 2024 Dec 2. doi: 10.1111/1346-8138.17569. Epub ahead of print. PMID: 39620595.}
2. ^{Hagino T, Onda M, Saeki H, Fujimoto E, Kanda N. Effectiveness of bimekizumab for genital, nail, and scalp lesions with psoriasis: a 24-week real-world study. J Dermatol. 2024. doi: 10.1111/1346-8138.17427.}