Psoriasis Drug Guselkumab Shows Durable Skin Clearance Through 5 Years for Adults

Janssen Pharmaceutical Companies’ first-in-class interleukin (IL)-23 inhibitor guselkumab (Tremfya) provided a consistent, high degree of durable skin clearance through 5 years for a majority of adult patients across broad subpopulations with moderate to severe plaque psoriasis (PsO) in the phase 3 VOYAGE 1 and VOYAGE 2 clinical trials, the Johnson & Johnson subsidiary said in a statement.

A separate post-hoc analysis of the VOYAGE studies showed that guselkumab provided high rates of durability and efficacy through 5 years and similar safety outcomes among patients with and without metabolic syndrome status at baseline.

These data are among 10 abstracts presented at the 2022 American Academy of Dermatology Annual Meeting taking place March 25 to 29, 2022.

Guselkumab is the first selective IL-23 inhibitor therapy approved in the United States to treat both adults with active psoriatic arthritis and adults with moderate to severe plaque PsO who are candidates for phototherapy or systemic therapy, Janssen said in the statement.

“The latest analyses of VOYAGE 1 and 2 complement the previously reported 5-year data from the studies,” Joseph F. Merola, MD, a research/clinical fellow at Brigham and Women’s Hospital and an associate professor of dermatology at Harvard Medical School, said in a statement. “These additional insights into the potential for Tremfya to mitigate the varied symptoms of psoriasis across broad populations are helpful to physicians as we seek long-term treatment solutions for the many symptoms our patients face with this disease.”

For an estimated 125 million people worldwide, plaque PsO can be debilitating and have different symptoms, both physical and psychological. Plaque PsO can cause inflamed, scaly skin plaques, as well as social distress. 

A pooled analysis of VOYAGE 1 and 2 evaluated the efficacy of guselkumab in 1829 patients across subgroups based on disease severity and treatment history, including an open-label extension period from weeks 52 to 252. Across the subgroups evaluated, approximately 80% of patients achieved and maintained skin clearance as measured by an Investigator’s Global Assessment (IGA) score of 0/1b or a Psoriasis Area Severity Index (PASI) 90c response.

IGA 0/1 and PASI 90 responses were evaluated across subgroups defined by patients’ baseline PASI and IGA scores, body surface area, and prior PsO treatments. Among guselkumab-treated patients, IGA 0/1 or PASI 90 responses were comparable across baseline disease severity characteristics, prior non-biologic systemic therapy, and prior phototherapy. This trend was consistent across subgroups, and the level of efficacy was maintained at each timepoint evaluated.

In a separate post-hoc analysis of VOYAGE 1 and 2 data, guselkumab demonstrated high levels of skin clearance, assessed by the achievement of IGA 0/1, PASI 90, and PASI 100 responses among patients with and without metabolic syndrome (MetS).

Among guselkumab-treated patients, 77.7% with MetS (n=256) and 83.4% without MetS (n=1118) achieved PASI 90 at week 252. MetS is strongly associated with plaque PsO and should considered in treatment decisions. These levels of clear or almost clear skin were maintained over time from weeks 100 to 252 across both groups in patients with or without MetS.

Reference

New data show majority of adults with moderate to severe plaque psoriasis treated with first-in-class TREMFYA® (guselkumab) experienced durable skin clearance through five years regardless of metabolic syndrome status, baseline disease severity, or treatment history. Johnson & Johnson. News release. March 25, 2022. Accessed March 28, 2022. https://www.jnj.com/new-data-show-majority-of-adults-with-moderate-to-severe-plaque-psoriasis-treated-with-first-in-class-tremfya-guselkumab-experienced-durable-skin-clearance-through-five-years-reguardless-of-metabolic-syndrome-status-baseline-disease-severity-or-treatment-history