Phase 3 data show Tremfya improves scalp psoriasis in patients with skin of color

Key takeaways:

• Significantly more patients treated with Tremfya vs. placebo achieved a nearly 90% improvement in severity (65.8% vs. 3.8%).
• 68.4% of Tremfya-treated patients achieved a Scalp-Specific IGA score of 0/1 vs. 11.5% of placebo.

Patients with skin of color that suffer from scalp psoriasis saw significant improvement in their disease severity, scalp itch and quality of life outcomes when treated with Tremfya, according to newly released phase 3 results.

“Despite strides in health care equity, patients with nonwhite skin or diverse skin tones living with plaque and scalp psoriasis still encounter significant obstacles stemming from factors like race, socioeconomic disparities, implicit bias and limited awareness of how the disease can present differently in people with nonwhite skin or diverse skin tones,” Jennifer Soung, MD, director of clinical research at Southern California Dermatology and one of the study’s authors, told Healio.

“Scalp psoriasis is a clinically proven difficult-to-treat area that some patients and doctors can mistake for other conditions, such as dandruff,” Soung continued. “It’s also believed that scalp psoriasis is more common and more severe in people with nonwhite skin or diverse skin tones.”

According to Soung, patients with skin of color can experience more severe scaling and itching than their white counterparts, but these patients often have textured hair that requires less washing, making it harder to remove scalp psoriasis flakes.

As a result, the prospective, large-scale, randomized, controlled, phase 3b VISIBLE study evaluated the efficacy of Tremfya (guselkumab, Janssen), an interleukin-23 inhibitor, for the treatment of scalp psoriasis specifically in patients with skin of color.

Results

While prior results from VISIBLE have been released, these new findings presented during Maui Derm Hawaii 2024 were from the second cohort, or cohort B.

In VISIBLE cohort B, 108 patients with skin of color were randomly assigned to receive guselkumab 100 mg or placebo at weeks 0, 4 and then every 8 weeks.

By week 16, after just three doses, 65.8% of Tremfya-treated patients achieved Psoriasis Scalp Severity Index 90, one of the study’s primary endpoints, vs. 3.8% of placebo-treated patients. Further, a significantly higher proportion of Tremfya-treated patients achieved a Scalp-Specific IGA score of 0/1, the other primary endpoint, vs. placebo-treated patients (68.4% vs. 11.5%).

A nearly 90% improvement from baseline in severity and scalp surface area involvement was achieved by 87.6% and 86.6% of patients treated with Tremfya, respectively, vs. 37.8% and 33.4% of patients treated with placebo. Significantly greater improvements in quality-of-life outcomes were also reported by Tremfya-treated patients compared with placebo across all skin tones.

While Tremfya is not indicated to treat post-inflammatory pigment alteration from psoriasis, a complication that often affects patients with skin of color, patients reported that, due to their improvement during Tremfya treatment, they experienced only mild skin discoloration.

Unique contributions

“Historically, people with nonwhite skin or diverse skin tones have been underrepresented in clinical research, accounting for only 14% of participants in some phase 3 psoriasis clinical studies,” Soung said. “Due to these representation gaps, people with nonwhite skin or diverse skin tones living with psoriasis encounter significant challenges, like delayed diagnosis, misdiagnosis and undertreatment.”

VISIBLE is the first phase 3 study to dedicate its resources entirely to people with skin of color with plaque and scalp psoriasis, according to Soung. The study was designed using a “holistic, community-driven approach,” wherein investigators intentionally selected patients from racially and ethnically diverse communities.

A committee of diverse dermatologists oversaw the study and were involved in protocol development, study execution, community engagement, awareness building and educational and cultural training support for the investigators.

According to Soung, the study also used colorimetry in order to maintain objective evaluations of progress and minimize the risk for investigator subjectivity given the diverse spectrum of patients.

“Recognizing psoriasis can be more challenging in individuals with darker skin tones as it may appear purple, gray or darker brown rather than the typical reddening seen in lighter skin — and this difference in presentation can sometimes lead to delayed or incorrect diagnoses,” Soung said. “By advocating for more diverse clinical studies within the dermatology space, clinicians and patients will ultimately be better equipped to recognize these conditions on darker skin tones and treat them appropriately.”

Impact

This study captured more than 20,000 images of disease presentation in patients with skin of color, a literary contribution that was much needed to better diagnose these patients.

“The collective data from both cohort A and cohort B reinforces that the unique study design of VISIBLE is a successful model to enroll, retain and support people with nonwhite skin or diverse skin tones who have historically been undertreated and underrepresented in clinical trials, and an inclusive research process may create lasting impact on furthering medical education and patient education,” Soung concluded.

Reference:

• Stein Gold L, et al. VISIBLE cohort B: Guselkumab improves key health-related quality of life measures at week 16 in participants with moderate to severe scalp psoriasis across all skin tones. Presented at: Maui Derm; Jan. 22-26, 2024; Wailea, Hawaii.