Rapid Scalp, Nail Pain, Itch Improvements Observed with Ixekizumab Treatment of Psoriasis

Rapid improvements in symptoms of moderate-to-severe plaque psoriasis may occur with ixekizumab treatment, according to recent real-world findings, with scalp pain and itch, nail pain, and quality of life improvements noted specifically by the 4-week mark.¹

These data resulted from new research conducted given ixekizumab’s lack of real-world data related to the biologic’s rapid efficacy in high impact regions such as scalp and nails. The drug is approved as a biologic option for the treatment of moderate-to-severe psoriasis.

This recent study was known as the ‘Rapid Response of Ixekizumab on Scalp Itch, Scalp and Nail Pain, and Quality of Life from the Interim Analysis of the PSOriasis Special Areas (PSoSA) Observational Study.’ It was authored in part by Abel Jarell, MD, from Northeast Dermatology Associates Portsmouth in New Hampshire, and presented at Maui Derm NP+PA Fall 2024 in Nashville.

“This analysis evaluates patient reported outcomes (PROs) such as scalp itch, nail and scalp pain, and health-related quality of life, among patients with PsO in high impact sites,” Jarell and colleagues wrote.

Design and Findings

Jarell and colleagues conducted an interim analysis of the PSOriasis Special Areas (PSoSA) observational study based in the US. PSoSA was designed with the purpose of tracking adult subjects with diagnoses of moderate-to-severe psoriasis, and specifically patients reporting nail involvement, possibly scalp involvement, and who have been prescribed ixekizumab therapy.

Ixekizumab had shown promise following its US Food and Drug Administration (FDA) approval in 2016 for psoriasis. It had been shown to be efficacious and safe for up to 5 years among those with moderate-to-severe disease, with rapid response being a predictor of long-term response and body mass index (BMI) being the major predictor of non-early success.²

In Jarell and colleagues’ interim study of PSoSA, a descriptive analysis was carried out by the team on observed data. During their analysis, the investigators looked at 92 participants’ data.

The team assessed subjects’ percentage change from the point of baseline using the Scalp Itch Numeric Rating Scale (NRS), Nail Pain NRS, and Scalp Pain NRS, with assessments done at the 4 and 12-week marks.

The NRS is a scale made up of 11 points, with data being patient-administered and scores on the scale having a range from 0 (suggesting lack of any itch or pain) to 10 (a rating considered the worst imaginable pain or itch). The research team also considered the proportion of subjects reporting a score of 0 or 1 on the Dermatology Life Quality Index (DLQI), scores which would reflect minimal or no psoriasis impact on one’s quality of life.

DLQI score were also assessed by the investigators at the 4-week and 12-week marks. Patients’ DLQI scores have a range from 0 - 30, with higher scores suggesting greater levels of impairment.

A decrease in subjects’ baseline mean Scalp Itch NRS score of 5.5 (standard deviation [SD] = 2.6) of 44.7% was observed by the research team among 62 participants. The 44.7% decrease (SD = 71.1, 44 subjects) was noted at the 4-week mark and this decrease became 72.8% (SD = 35.0, 35 subjects) by the 12-week mark.

For the baseline mean Scalp Pain NRS of 3.4 (SD = 3.1, 61 subjects), investigators reported a reduction of 56.9% (SD = 49.3, 32 subjects) at the 4-week mark and 84.8% (SD = 35.2, 27 subjects) at the 12-week mark.

In a similar vein, the research team found that baseline mean Nail Pain NRS scores of 2.4 (SD = 2.4, 74 subjects) diminished by 23.3% (SD = 77.3, 37 subjects) at the 4-week mark and by 53.3% (SD = 59.0, 26 subjects) at the 12-week mark.

In their assessment of quality of life improvements while using ixekizumab, the team concluded that 21.4% of patients (15 of 70) had a DLQI score of 0 or 1 by the 4-week mark. This was shown to increase to 43.6% (24 of 55) by the 12-week mark.

Overall, the investigators’ interim analysis of the PSoSA study indicated rapid and substantial improvements to symptoms of their psoriasis, particularly among subjects with nail and possibly scalp involvement. Such real-world data support the clinical benefits of ixekizumab that had been seen in controlled trials.

References

1. ^{Jarell A, Serrao R, Merola J, et al. Rapid Response of Ixekizumab on Scalp Itch, Scalp and Nail Pain, and Quality of Life from the Interim Analysis of the PSOriasis Special Areas (PSoSA) Observational Study. Abstract presented at Maui Derm NP+PA Fall 2024. Nashville, TN. September 15-18, 2024.}
2. ^{Smith T. Ixekizumab Shown to be Safe, Effective for Up to 5 Years for Psoriasis. HCPLive. January 2, 2024. https://www.hcplive.com/view/ixekizumab-shown-to-be-safe-effective-for-up-to-5-years-for-psoriasis. Date accessed: September 16, 2024.}