Janssen's IL-23 Inhibitor Tremfya Demonstrates Long-Term Efficacy in Durably Improving Multiple Symptoms in Patients with Psoriatic Arthritis

On November 1, 2021, Janssen, a Johnson & Johnson company, announced that an updated analysis of Phase 3 clinical trial data for the selective interleukin (IL)-23 inhibitor Tremfya (guselkumab) demonstrated that, in adult patients with active psoriatic arthritis (PsA), compared with placebo, Tremfya (guselkumab) inhibited radiographic progression and provided substantial and sustained improvements in multiple joint symptoms, such as axial symptoms, dactylitis, and pain.

Psoriatic arthritis is a chronic inflammatory disease that can lead to irreversible joint deformity and disability. It is estimated that over 50 million people worldwide are affected by psoriatic arthritis. The disease typically first affects the joints of the fingers and toes, causing joint swelling and pain while impairing joint mobility, accompanied by nail and toenail lesions. In patients with severe disease, other joints may also be affected, significantly compromising motor function.

Tremfya is a specific anti-IL-23 monoclonal antibody developed by Janssen that binds to the p19 subunit of IL-23 to block its action. In 2017, Tremfya received U.S. FDA approval for the treatment of adult patients with moderate-to-severe plaque psoriasis. The press release noted that Tremfya is the first selective IL-23 inhibitor approved in the United States for the treatment of adult patients with moderate-to-severe plaque psoriasis and adult patients with active psoriatic arthritis (PsA). In December 2019, guselkumab (generic name: guselkumab; brand name: Tremfya) was approved in China for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

The key results obtained from this analysis are as follows:

The mean change in radiographic scores from Weeks 52 to 100 indicates that Tremfya is associated with a low rate of radiographic progression, a key indicator of structural damage in patients.

Tremfya treatment continued to improve symptoms of axial involvement in patients with active PsA and sacroiliitis (up to 100 weeks), with a substantial proportion of patients achieving and maintaining a clinically meaningful improvement in the Ankylosing Spondylitis Disease Activity Score (ASDAS).

Tremfya significantly improved dactylitis symptoms in 83% of biologic-naïve PsA patients (through 100 weeks).

In clinical trials, Tremfya also consistently and durably improved multiple measures assessing patient pain symptoms.

Analysis of safety data demonstrated that TREMFYA exhibited a consistent safety profile between patients with active PsA (2-year follow-up) and those with moderate to severe plaque psoriasis (5-year follow-up). The incidence of serious adverse events (SAEs), gastrointestinal-related SAEs, and adverse events of interest (including candidiasis, uveitis, and opportunistic infections) was low.

References:

[1] New Phase 3 First-in-Class Tremfya® (guselkumab) Data Show Durability of Joint Efficacy, Including Low Rates of Structural Damage Progression, and a Demonstrated Safety Profile in Adults with Active Psoriatic Arthritis (PsA). Retrieved November 1, 2021, from https://www.prnewswire.com/news-releases/new-phase-3-first-in-class-tremfya-guselkumab-data-show-durability-of-joint-efficacy-including-low-rates-of-structural-damage-progression-and-a-demonstrated-safety-profile-in-adults-with-active-psoriatic-arthritis-psa-301412935.html

(The original text has been abridged)

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