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Data Show Durable, Complete Plaque Psoriasis Skin Clearance Through 5 Years With Guselkumab - Pharmacy Times

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Guselkumab also showed promising results in the treatment of psoriatic arthritis, with improved disease activity in joints and across multiple domains through 1 year.

New research has shown promising results for guselkumab (Tremfya) in the treatment of moderate to severe plaque psoriasis, with durable, complete skin clearance rates in the majority of adults through 5 years, according to a press release. The treatment has also shown promise in the treatment of psoriatic arthritis.

“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, MD, PhD, lead author of the VOYAGE-2 study, in the press release. “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 [interleukin]-23 inhibitor treatment for moderate to severe plaque psoriasis and active psoriatic arthritis.”

Guselkumab is the only selective IL-23 inhibitor therapy approved to treat both adults with active psoriatic arthritis and adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The new data show sustained, durable skin clearance rates through 5 years, as well as improved disease activity and axial symptoms in adults with active psoriatic arthritis through 1 year.

In the VOYAGE-2 trial, 55.5% of patients in the group receiving guselkumab achieved an Investigator’s Global Assessment (IGA) score of 0, indicating complete skin clearance, and 53% achieved a Psoriasis Area Severity Index 100 skin clearance response (PASI 100) at week 252. Furthermore, 82% achieved a PASI 90 skin clearance response and 85% achieved an IGA score of 0/1, indicating clear or almost clear.

These high efficacy rates were maintained through 5 years of treatment with guselkumab, based on analyses using pre-specific treatment failure rules, according to a press release. Across both the VOYAGE-1 and -2 trials, 78.4% of patients with moderate to severe plaque psoriasis continued treatment through week 252. The trials showed a consistent safety profile from year 1 through year 5 with low rates of adverse effects (AEs) leading to discontinuation and serious AEs.

In addition to these findings, similar results have been seen in the treatment of psoriatic arthritis, based on data from the DISCOVER-1 and -2 trials.

Guselkumab 100 mg every 4 weeks and every 8 weeks improved psoriatic disease activity in joints and across multiple domains through 1 year in both DISCOVER trials. Differences in response rates between guselkumab and placebo were seen as early as week 8 of the trials, according to the press release. Data from a separate abstract also showed that guselkumab is the first IL-23 inhibitor to provide sustained improvements in psoriatic arthritis axial symptoms.

“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 at Janssen Research & Development LLC, in the press release.

REFERENCE

1. 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). News release. Johnson & Johnson; April 23, 2021. https://www.jnj.com/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. Accessed May 14, 2021.

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