Tremfya Safe, Effective Across Broad Patient Subpopulations Through 5 Years: Analysis

March 25, 2022
Tremfya Safe Effective Across Broad Patient Subpopulations Through Five Years Analysis image

Tremfya® (guselkumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson can provide a consistent, high degree of durable skin clearance through 5 years in a majority of adult patients across broad subpopulations with moderate to severe plaque psoriasis (PsO), based on an analysis of data from the phase 3 VOYAGE 1 and VOYAGE 2 clinical trials.

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

These data were among 10 abstracts presented at the 2023 American Academy of Dermatology Annual Meeting. Tremfya is the first selective IL-23 inhibitor therapy approved in the United States to treat both adults with moderate to severe plaque PsO who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis (PsA).

"The latest analyses of VOYAGE 1 and 2 complement the previously reported 5-year data from the studies," says Joseph Merola, MD, MMSc, an associate professor at Harvard Medical School, Brigham and Women's Hospital. "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."

Across the subgroups evaluated in VOYAGE 1 and 2, approximately 80% of patients achieved and maintained skin clearance, as measured by an Investigator's Global Assessment (IGA) Score of 0/1 or a Psoriasis Area Severity Index (PASI) 90 response.

Among Tremfya-treated patients, IGA 0/1 or PASI 90 responses were comparable across baseline disease severity characteristics, prior phototherapy, and prior nonbiologic systemic therapy. This trend was consistent across subgroups, and the level of efficacy was maintained at each time point evaluated.

Tremfya provided significant clinical improvements for patients across multiple measures of health-related quality of life. Results from VOYAGE 1 and 2 show patients with moderate to severe PsO receiving Tremfya reported social relationship difficulty and sexual difficulty measures improved as their skin symptoms improved, based on related questions included in the Dermatology Life Quality Index questionnaire and PASI scores. Two new analyses showed greater proportions of patients taking Tremfya versus placebo achieved clinically meaningful improvements in fatigue from baseline across both moderate to severe plaque PsO (at week 16) in the VOYAGE studies and active PsA (at week 24) in the DISCOVER-1 and 2 studies, as measured by the 36-Item Short-Form Health Survey vitality scale.

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