Johnson & Johnson has officially announced published results from a trial, which saw its drug TREMFYA® achieving clear or almost clear skin in the majority of adults with low body surface area (BSA), moderate plaque psoriasis (PsO), with special site involvement who had failed topical treatment.
In case you weren’t aware, sensitive or highly visible areas affected by PsO, including the scalp, face, skin folds and genitals, are considered “special sites” and can have significant impact on patients’ daily lives,
Anyway, talk about the condition on a slightly deeper level, Plaque PsO is an immune-mediated disease which triggers overproduction of skin cells that, in turn, cause inflamed, scaly, itchy, and potentially painful plaques. At present, the condition affects eight million Americans and more than 125 million people worldwide. In fact, nearly one-quarter of all people with plaque PsO have cases that are considered moderate to severe.
Against that, TREMFYA arrives on the scene as the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cell that produce IL-23).
To prove the efficiency of this drug, researchers at Johnson & Johnson also conducted a Phase 3b SPECTREM study, the first prospective, large-scale, randomized-controlled, double-blind clinical study to measure skin clearance and other treatment outcomes in low BSA moderate PsO with involvement across four special sites (scalp, face, skin folds and genitals), and previous topical treatment failure,
Going by the results of this study, a significantly greater proportion of patients who received TREMFYA® achieved the primary endpoint of an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal disease (1), compared to those who received placebo (74.2% versus 12.4%, respectively; p<0.001). These results were comparable irrespective of baseline BSA.
Furthermore, the study saw that complete clearance of each special site was consistently achieved in the majority of patients who received TREMFYA® versus placebo: scalp (60.3% versus 9.3%), face (75.7% versus 23.9%), intertriginous (76.6% versus 24.2%) and genital (72.7% versus 32.7%).
Moving on, the trial also had 52.9% participants achieving a Psoriasis Area Severity Index (PASI) 90 response, compared to 6.2% of participants who received placebo.
On top of that, the average patient experienced over 80% improvement from baseline for both BSA and PASI compared to those who received placebo (80.6% versus 6.1% and 82.6% versus 13.7%, respectively; p<0.001). Markedly enough, a greater proportion of TREMFYA®-treated patients also clocked Dermatology Life Quality Index (DLQI) scores of 0/1 compared to patients receiving placebo (48.9% versus 3.5%).
To go along with that, the trial saw an improvement of almost 4 points from baseline in Psoriasis Symptoms and Signs Diary (PSSD) itch, when pitted against placebo (62.7% versus 12.5%).
“People who have special site plaque psoriasis with lesions that cover a smaller total area of their body are often only prescribed topical treatments and not considered candidates for advanced therapies, as treatment decisions are often driven by body surface area coverage and not symptomatic burden,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health, and SPECTREM investigator. “Results of the SPECTREM study could represent a new approach to care for patients with low body surface area psoriasis.”
Beyond the therapeutic itself, Johnson & Johnson also unveiled TREMFYA® Clearance Photo Library, which happens to be an expansive, longitudinal database of before and after treatment photographs from a separate Phase 3b VISIBLE study.
According to certain reports, this particular tool basically makes it possible for patient images to be filtered based on clinical characteristics, such as disease severity, areas of involvement, and clearance outcomes across all skin tones. Beyond its existing database, the library will continue to be updated with more images from ongoing and future studies that address underrepresented PsO patient types.
To understand the significance of such a development, we must try and understand that only 4-19% of images in dermatology textbooks show PsO on darker skin tones, indicating a clear challenge in the recognition of disease across patients with skin of color.
