Guselkumab Phase 3 Data Show Sustained Skin Clearance After 5 Years

The Janssen Pharmaceutical Companies of Johnson & Johnson announced new Phase 3 data which showed guselkumab (Tremfya) sustained durable, complete skin clearance rates in a majority of adults with moderate to severe plaque psoriasis (PsO) through 5 years (252 weeks), and improved disease activity and axial symptoms in adults with active psoriatic arthritis (PsA) through one year (52 weeks).

These data are being presented at the American Academy of Dermatology Virtual Meeting Experience 2021, where Janssen will present a total of 22 abstracts. TREMFYA is the first and only selective interleukin (IL)-23 inhibitor therapy approved in the U.S. to treat both adults with moderate to severe plaque PsO who are candidates for systemic therapy or phototherapy and adults with active PsA.

"People living with psoriatic disease can face a lifetime of physical pain and discomfort, which places a significant burden on their lives," said Kristian Reich,b MD, PhD, professor of translational research in inflammatory skin diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Germany, and lead author of the VOYAGE 2 study. "The signs and symptom improvements seen with TREMFYA are noteworthy for both patients who live with fear of disease recurrence and their physicians, as these data add to a growing body of evidence for this first-in-class IL-23 inhibitor treatment for moderate to severe plaque psoriasis and active psoriatic arthritis."

The Janssen Pharmaceutical Companies of Johnson & Johnson announced new Phase 3 data which showed TREMFYA® (guselkumab) sustained durable, complete skin clearance rates in a majority of adults with moderate to severe plaque psoriasis (PsO) through 5 years (252 weeks), and improved disease activity and axial symptoms in adults with active psoriatic arthritis (PsA) through one year (52 weeks). These data are being presented at the American Academy of Dermatology Virtual Meeting Experience 2021, where Janssen will present a total of 22 abstracts. TREMFYA is the first and only selective interleukin (IL)-23 inhibitor therapy approved in the U.S. to treat both adults with moderate to severe plaque PsO who are candidates for systemic therapy or phototherapy and adults with active PsA.

"People living with psoriatic disease can face a lifetime of physical pain and discomfort, which places a significant burden on their lives," said Kristian Reich,b MD, PhD, professor of translational research in inflammatory skin diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Germany, and lead author of the VOYAGE 2 study. "The signs and symptom improvements seen with TREMFYA are noteworthy for both patients who live with fear of disease recurrence and their physicians, as these data add to a growing body of evidence for this first-in-class IL-23 inhibitor treatment for moderate to severe plaque psoriasis and active psoriatic arthritis."

Results show:

• Durable and Complete Skin Clearance Rates: In the PsO trial VOYAGE 2 (POSTER #27859), 55.5 percent of patients in the TREMFYA group achieved an Investigator's Global Assessment (IGA) score of 0, indicating complete skin clearance, and 53% achieved a Psoriasis Area Severity Index (PASI) 100 skin clearance response (PASI 100) at week 252. Additionally, in the same trial, 82% achieved a PASI 90 skin clearance response and 85% achieved an IGA score of 0/1 (clear/almost clear). High efficacy rates were maintained through five years of TREMFYA treatment based on analyses using pre-specified treatment failure rules (patients discontinuing due to lack of efficacy, worsening of PsO, or use of a prohibited treatment were considered non-responders).
• Robust Joint Symptom Improvement: TREMFYA 100 mg every 4 weeks and every 8 weeks improved PsA disease activity in joints and across multiple domains through week 52 in both PsA trials, DISCOVER-1 and -2, as measured by the Disease Activity Index for PsA, Minimal Disease Activity, Very Low Disease Activity and remission determined using Disease Activity Index for PsA (POSTER #27038). Differences in response rates associated with composite indices between TREMFYA and placebo were seen as early as week 8 and increased over time through week 52. In addition, data from a separate abstract show TREMFYA is the first IL-23 inhibitor to provide sustained improvements in PsA axial symptoms based on change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and percentage of patients achieving a BASDAI 50 response through week 52 (POSTER #27851).
• Established Safety Profile: Across both PsO trials, VOYAGE 1 and 2, 78.4% of patients (n=1,349/1,721) with moderate to severe plaque PsO treated with TREMFYA continued treatment through week 252 (7,166 patient-years of follow-up). This comprehensive safety analysis of VOYAGE 1 and 2 showed a consistent safety profile for TREMFYA from year 1 through year 5 with low rates of adverse events (AEs) leading to discontinuation and serious AEs (POSTER #28095).

"The durable response rates seen in the majority of patients enrolled in the VOYAGE and DISCOVER trials further demonstrate the important role that TREMFYA has in helping patients with their moderate to severe plaque psoriasis and their active psoriatic arthritis and add to the volume of scientific insights provided by the comprehensive TREMFYA research program," said Lloyd S. Miller, MD, PhD, vice president, immunodermatology disease area leader, Janssen Research & Development, LLC.

This article was originally published by our sister publication Dermatology Times.

Reference

New Phase 3 Data Showed First-in-Class TREMFYA® (guselkumab) Provided Durable Complete Skin Clearance Through Five Years in Moderate to Severe Plaque Psoriasis (PsO) and Robust Joint Symptom Improvement Through 52 Weeks in Active Psoriatic Arthritis (PsA). Cision PR Newswire. April 23, 2021. Accessed April 24, 2021. https://www.prnewswire.com/news-releases/new-phase-3-data-showed-first-in-class-tremfya-guselkumab-provided-durable-complete-skin-clearance-through-five-years-in-moderate-to-severe-plaque-psoriasis-pso-and-robust-joint-symptom-improvement-through-52-weeks-in-active--301275807.html?tc=eml_cleartime