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Scalp psoriasis remains a challenging dermatological condition to manage, especially in people of color, due to its unique presentation and treatment response. The quest for effective treatments is ongoing, and recent developments have put a spotlight on guselkumab as findings from the phase 3b VISIBLE study demonstrated significant and rapid clearance in moderate to severe scalp psoriasis in people of color.

The VISIBLE study is a phase 3b, multicenter, randomized, double-blind clinical trial. Its primary objective is to evaluate the efficacy and safety of guselkumab, an interleukin-23 blocker, for the treatment of moderate to severe scalp psoriasis among people of color. This subgroup often experiences a higher burden of disease and differences in treatment efficacy, making the results of this study particularly valuable.

Study Results

After three doses at week 16, individuals treated with TREMFYA demonstrated significantly greater improvements compared to those receiving a placebo:

• Nearly 70 percent of guselkumab recipients achieved the study's co-primary endpoints, including a Scalp-Specific Investigator Global Assessment (ss-IGA) score of 0/1 (68.4 percent vs. 11.5 percent for placebo) and a Psoriasis Scalp Severity Index (PSSI) 90 response (65.8 percent vs. 3.8 percent for placebo). Importantly, approximately 90 percent of patients meeting these endpoints attained complete scalp clearance (ss-IGA 0 or PSSI 100).
• Patients on guselkumab experienced an almost 90 percent improvement from baseline in both PSSI (87.6 percent vs. 37.8 percent for placebo) and Scalp Surface Area (SSA) (86.6 percent vs. 33.4 percent for placebo).
• In this previously understudied population, no new safety signals were reported through week 16.
• Almost seven in 10 patients treated with guselkumab experienced a clinically significant enhancement on the Scalp Itch Numeric Rating Scale (NRS).
• Individuals receiving guselkumab demonstrated notably greater enhancements in both the Psoriasis Symptoms and Signs Diary (PSSD) and the Dermatology Life Quality Index (DLQI) compared to those on placebo, encompassing all skin tones.
• The Skin Discoloration Impact Evaluation Questionnaire (SDIEQ) revealed that, at baseline, the mean score indicated patients were facing a moderate impact of skin discoloration on their Health-Related Quality of Life (HRQoL).
• Patients undergoing guselkumab treatment reported experiencing improvements, indicating only a mild impact of skin discoloration on their HRQoL.

The VISIBLE clinical program will also generate an extensive longitudinal dataset comprising over 20,000 clinical images, encompassing all skin tones, to aid patients and healthcare providers in recognizing and understanding the disease. Cohort B of the study enrolled 108 individuals with moderate-to-severe psoriasis predominantly affecting the scalp, an area known for its clinical challenges in treatment.

With these positive results, the VISIBLE study marks a step forward in the management of scalp psoriasis and guselkumab could bridge gaps in care for people of color affected by this chronic condition.

Reference

TREMFYA® (guselkumab) Demonstrates Significant and Rapid Scalp Psoriasis Clearance in People of Color in New Large Phase 3b Study. Johnson & Johnson Innovative Medicine. Accessed February 2, 2024. https://www.janssen.com/johnson-johnson-innovative-medicine.