Guselkumab offers long-term safety in all skin types

All patients self-identified as non-White and nearly 69% of treated subjects had objectively measured Fitzpatrick skin types IV through VI

Dr. Geeta Yadav

Dr. Andrew Alexis

The IL-23 inhibitor guselkumab demonstrated efficacy out to 100 weeks in the treatment of psoriasis across a spectrum of skin types, according to poster research presented at the 2026 annual meeting of the American Academy of Dermatology (AAD) in Denver. A full report will be published in the June 2026 issue of The Chronicle of Skin & Allergy.

The VISIBLE trial, a phase 3b randomized, placebo-controlled study, assessed the efficacy of the biologic in participants with skin of colour who had moderate-to-severe psoriasis in one cohort (Cohort A) and moderate-to-severe scalp psoriasis in another (Cohort B), with two-year findings from Cohort A released at the AAD.

A total of 103 participants were randomized three-to-one to receive 100 mg of guselkumab or placebo, with crossover to guselkumab at Week 16. Outcome measures included the Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), Psoriatic Arthritis Impact of Disease (PsAID)-12, and the Skin Discoloration Impact Questionnaire (SDIEQ).

Through the second year, about 70% of guselkumab-treated subjects achieved clear or almost clear skin, measured as an Investigator Global Assessment (IGA) score of 0/1 and PASI 90 at Week 100, and more than half reached complete clearance, measured as IGA 0 and PASI 100.

“The complete clearance rates are the headline for me,” said Dr. Geeta Yadav, a dermatologist, founder of FACET Dermatology in Toronto, and one of the trial investigators. “Over 50 per cent of participants achieved an IGA of 0 and PASI 100 at Week 100, and about 70 per cent maintained an IGA score of 0/1 and PASI 90. With mean BSA [body surface area] and PASI improvements consistently above 90 per cent, these are robust, durable numbers.

“Responses were not just maintained but continued to improve over 100 weeks,” she added. “And the crossover group, those who switched from placebo to guselkumab at Week 16, achieved outcomes comparable to the continuous treatment arm, which speaks to the reliability of the response regardless of when treatment was initiated.”

Dr. Yadav noted that the study stood out because of its population, with close to 69% of Cohort A subjects having Fitzpatrick skin types IV through VI.

“That matters because the historical evidence base in psoriasis skews heavily toward lighter skin types,” she said. “I think the VISIBLE study sets a precedent. When you design a trial with intentional diverse enrolment and include endpoints such as skin discolouration that matter to these populations, you raise the bar for what inclusive trial design looks like. I am hopeful, and frankly expectant, that other programs will follow. The evidence base should reflect the patients we are treating.”

Presenting author Dr. Andrew Alexis, Professor of Clinical Dermatology at Weill Cornell Medicine in New York City, said the trial's inclusive design may serve as a template for future clinical studies in dermatology.

“What we would hope is that going forward psoriasis trials would include a broad range of skin phototypes that is representative of the North American and global population of psoriasis, such that we can confirm the safety and efficacy across the different demographics, but also better understand some of the unique sequelae that disproportionately affect patients with skin of colour, such as pigmentary alteration,” said Dr. Alexis.

“Seeing robust prospective data for a psoriasis therapy in this diverse cohort fills a real gap in the literature.”

He noted that the trial was novel in its use of colourimetry at study entry to capture a patient's constitutive skin tone in an objective, precise manner, going beyond the traditional approach to Fitzpatrick skin phototyping.

The SDIEQ was also an innovative measure used to assess skin discolouration. “[SDIEQ] is an instrument that you do not see very often in this context, and it demonstrated a significantly reduced impact of the pigmentary alteration associated with psoriasis over this 100-week period,” said Dr. Alexis

No new safety concerns emerged over the extended investigation.

With files from Assistant Editor Darren Stallman

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