Phase 3b Findings on Guselkumab Indicate Rapid Scalp Psoriasis Clearance in Patients of Color

Andrew Alexis, MD, MPH

Credit: Weill Cornell Medicine

Guselkumab (Tremfya) may lead to significant and rapid improvements in moderate-to-severe scalp psoriasis clearance among patients with skin of color, according to newly-announced findings, as well as improvements in health-related quality of life and post-inflammatory pigmentation.¹

These phase 2b findings on guselkumab were announced by Johnson & Johnson on January 22, having resulted from the VISIBLE study and having been presented at the Maui Derm Hawaii 2024 conference. Guselkumab is the first IL-23 inhibitor approved in the US for adult psoriasis patients who qualify for systemic therapy or for phototherapy.

The VISIBLE study represents the inaugural prospective, large-scale, randomized-controlled trial on guselkumab designed for individuals of diverse skin tones, specifically, who are experiencing plaque psoriasis and scalp psoriasis. The study had been designed to objectively examine outcomes related to both clearance and other measures using guselkumab.

"Scalp psoriasis is highly prevalent and can present unique challenges across diverse populations,” Andrew Alexis, MD, MPH, professor of clinical dermatology at Weill Cornell Medicine and lead study investigator, said in a statement. “In patients of color, cultural factors related to hair care practices and post-inflammatory pigment changes contribute to the burden of scalp psoriasis. These findings from VISIBLE are key to broadening our understanding of scalp psoriasis, and the role (guselkumab) can have in treating all patients with this disease.”

The study’s clinical program was designed to gather more than 20,000 clinical images spanning various types of skin tones. This may help to promote improved disease recognition as well as education among both psoriasis patients and among healthcare providers.

There were 3 posters highlighting these new findings, one of which was titled 'Guselkumab Significant and Rapid Scalp Clearance Data at Week 16.’ This poster showed the following:

• Following 3 total doses, those given guselkumab reported much greater improvement compared to placebo, at 16 weeks.
• Around 7 out of 10 study participants at Week 16 in the treatment arm ended up achieving the co-primary endpoints, a Scalp-Specific Investigator Global Assessment (ss-IGA) score of 0/1 and a Psoriasis Scalp Severity Index (PSSI) 90 response (68.4% versus 11.5% placebo and 65.8% versus 3.8% placebo, respectively).
• The investigators added that around 90% of subjects who met the co-primary endpoints reported complete clearance of the scalp (ss-IGA 0 or PSSI 100)
• Almost 90 percent improvement from baseline in participants’ PSSI was observed in the treatment arm (with 87.6% compared to 37.8% in the placebo arm) and in scores related to Scalp Surface Area (SSA) (86.6% versus 33.4% placebo)
• Additionally, no major new safety signals were observed by the research team.

In the second poster, titled 'Guselkumab Patient-Reported Health-Related Quality of Life (HRQoL) Improvements' the following findings were highlighted:

• The investigators reported 69.4% of subjects treated with guselkumab, compared to 24% in the placebo arm, were shown to have clinically meaningful Scalp Itch Numeric Rating Scale (NRS) improvements by the 16-week mark.
• By this same point in time, the team reported far greater Psoriasis Symptoms and Signs Diary (PSSD) and Dermatology Life Quality Index (DLQI) improvements among those in the treatment arm across all different skin tones.

The third poster highlighted in the announcement looked at data surrounding post-inflammatory pigment alteration (PIPA), which is noted as skin discoloration which may result from either inflammation or injury and is a part of conditions such as psoriasis. This is particularly the case among those with melanin-enriched skin.

In this poster, titled 'Guselkumab Patient-Reported Post-Inflammatory Pigmentation Data,' the following highlighted findings were included:

• Mean score at the point of baseline, evaluated through the Skin Discoloration Impact Evaluation Questionnaire (SDIEQ), showed that moderate effects of skin discoloration on HRQoL were seen.
• Participants treated with guselkumab, at 16 weeks, were shown to have reported improvements. It was added that only mild impacts related to skin discoloration were observed for their HRQoL. Guselkumab is not, however, designed for PIPA treatment.

In October 2023, this study had introduced Cohort A which had aimed at patients with skin-predominant psoriasis that also came from diverse ethnic backgrounds. Along with the recent discoveries seen in Cohort B, the research may lead to improved understanding of this patient population.

"The VISIBLE study will continue to generate insights and data that may help clinicians improve the disease journey and health outcomes for people of color with skin and scalp plaque psoriasis who have historically been undertreated and underrepresented in clinical research and in medical education,” Alexis said in a statement.

References

1. ^{TREMFYA® (guselkumab) Demonstrates Significant and Rapid Scalp Psoriasis Clearance in People of Color in New Large Phase 3b Study. Johnson & Johnson. January 22, 2024. https://www.prnewswire.com/news-releases/tremfya-guselkumab-demonstrates-significant-and-rapid-scalp-psoriasis-clearance-in-people-of-color-in-new-large-phase-3b-study-302040661.html. Date accessed: January 22, 2024.}