Janssen’s GUIDE data demonstrate that patients treated with guselkumab less than 2 years after disease onset vs later are more likely to achieve “super-responder” at week 20 through 28.
New data for guselkumab (Tremfya; Janssen Pharmaceuticals) from the ongoing phase 3b GUIDE (NCT03818035) study, show that individuals who received the drug every 16 weeks maintain disease control of moderate to severe plaque psoriasis (Pso) that was non-inferior to individuals who received it ever 8 weeks.
Investigators found that individuals who received the every-16-week dosing maintained the disease control, using the absolute Psoriasis Area and Severity Index (PASI) score, at 92.6% compared with those who were on the every-8-week dosing at 91.9%, which met the study’s primary endpoint at week 68.
“These new results suggest patients who receive treatment soon after disease onset may see higher rates of psoriasis clearance and in the future, we hope that dosing-interval flexibility could be a consideration that would allow this patient population to have a therapy strategy tailored to them,” Kilian Eyerich, MD, professor and medical director of the Department of Dermatology at Medical Center – University Freiburg in Breisgau. Germany, said in a statement. “As we continue to analyze and understand the data from GUIDE, we hope to understand clinical outcomes from different patients with varying underlying immunological changes that may help inform individualized guselkumab therapeutic strategies in the future.”
Guselkumab is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits interaction with IL-23 receptors.
The GUIDE study was designed to understand the impact of early intervention and potential dosing interval flexibility on the long-term disease course in adult individuals with moderate to severe plaque Pso.
The data build on previous analyses that showed individuals with moderate to severe plaque Pso who initiated treatment with guselkumab less than or equal to 2 years from onset of signs and symptoms are more likely to achieve “super-responder status,” defined as those who received on-label treatment with guselkumab until week 20 and responses with a PASI score of 0d at both weeks 20 and 28.
In the 5-year VOYAGE 1 and VOYAGE 2 trials, investigators found that high levels of health-related quality of life, which was defined as Dermatology Life Quality Index score of 0 or 1, was achieved in individuals with complete or almost complete skin clearance. They also found that this was sustained at a consistent level, ranging from 87.1% to 95.5%, for those who achieved PASI 100, measured every 24 weeks from 100 weeks through 252 weeks of treatment with guselkumab.
They also found that clear skin responses were consistently maintained through 5 years with treatment for individuals with baseline scalp or nail plaque Pso, regardless of severity at baseline.
Furthermore, in a post-hoc analysis, investigators found that the majority of individuals with moderate to severe plaque Pso achieved either 90% improvement or greater in PASI or a 100% improvement in PASI. The data were durable and remained consistent through week 252.
Data from the GUIDE, VOYAGE 1 (NCT02207231), and VOYAGE 2 (NCT02207244) studies were presented at the European Academy of Dermatology and Venereology 31st Congress as 38 abstracts.
Tremfya (guselkumab) demonstrates higher rates of complete skin clearance with earlier treatment in adults with moderate to severe plaque psoriasis in phase 3b GUIDE study. News release. Janssen Pharmaceuticals. September 8, 2022. Accessed September 19, 2022. https://www.jnj.com/tremfya-guselkumab-demonstrates-higher-rates-of-complete-skin-clearance-with-earlier-treatment-in-adults-with-moderate-to-severe-plaque-psoriasis-in-phase-3b-guide-study