Janssen Pharmaceuticals has released topline data from one of the cohorts in the VISIBLE trial in plaque psoriasis.
The Phase IIIb study is investigating Tremfya (guselkumab) in plaque and scalp psoriasis patients across all skin tones.
The newly released data showed Tremfya met two co-primary endpoints at week 16. The majority of patients (74%) treated with Tremfya from Cohort A achieved a cleared or minimal disease score on the Investigator’s Global Assessment (IGA) scale. Also, more than half of them (57.1%) achieved at least a 90% improvement in the Psoriasis Area Severity Index (PASI 90) response.
Tremfya also demonstrated early efficacy in clearing scalp psoriasis. As early as week 4, patients treated with Tremfya showed a mean percentage change of 53.8% in the Psoriasis Scalp Severity Index (PSSI) compared to 12.3% in the placebo cohort. At week 16, 71.9% of treated patients achieved complete scalp clearance compared to 10% in the placebo cohort.
The VISIBLE trial (NCT05272150) enrolled 211 patients who self-identified as non-white. Cohort A included plaque psoriasis patients, whereas Cohort B recruited participants with scalp psoriasis. Participants received either a 100mg dose of Tremfya or a placebo. At week 16, the placebo cohort then crossed over to the Tremfya arm.
The trial is still ongoing with an active treatment period of dosing every eight weeks lasting from week 16 to 48, and a long-term extension through week 112. The study is being conducted in the US and Canada.
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Misrepresentation of skin colour
According to Janssen, the trial aims to expand the understanding and generate clinical images of plaque psoriasis across all skin tones. The company stated that only 4%-19% of images in dermatology textbooks showcase conditions in darker skin tones.
Central Connecticut Dermatology and VISIBLE Steering Committee member Dr Mona Shahriari said: “VISIBLE reinforces that to overcome the barriers of underrepresentation, undertreatment, and lack of access to care that many people of colour with plaque psoriasis face, additional data about the disease journey are needed to improve treatment outcomes and quality of life in people with skin of colour.”
Indeed, dermatology indications appear differently on various skin tones. For example, plaque psoriasis appears purple, grey or darker brown on darker skin tones compared to typical red tones on lighter skin. Clinical Trials Arena has previously reported on diversity challenges in dermatology clinical trials and the use of telemedicine.
To further tackle diversity, Janssen intentionally selected sites and investigators from diverse communities. Racially and ethnically diverse dermatologists were involved in the protocol development and trial execution. Inclusion of diverse staff in trials can help overcome diversity hurdles, especially in challenging disease areas such as mental health disorders.