Janssen’s Tremfya meets primary endpoint in Discover studies

12th November 2019 (Last Updated December 24th, 2019 06:52)

Janssen Pharmaceutical has reported positive data from the Phase III Discover-1 and Discover-2 clinical trials of Tremfya (guselkumab) in patients with active psoriatic arthritis (PsA).

Janssen’s Tremfya meets primary endpoint in Discover studies
Janssen is developing Tremfya to treat inflammatory diseases such as plaque psoriasis and psoriatic arthritis. Credit: Bic.

Janssen Pharmaceutical has reported positive data from the Phase III Discover-1 and Discover-2 clinical trials of Tremfya (guselkumab) in patients with active psoriatic arthritis (PsA).

According to the 24-week data, the drug met the primary endpoint of superior ACR20 responses, demonstrating at least a 20% improvement in signs and symptoms in a significantly greater proportion of patients compared to placebo.

Tremfya is a human monoclonal antibody targeting the p19 subunit of IL-23, which is involved in the pathogenesis of inflammatory diseases, including psoriatic arthritis.

The Discover-1 and Discover-2 trials assessed the safety and efficacy of a subcutaneous formulation of the drug in 381 and 739 adults with active PsA, respectively.

Discover-1 involved patients with an inadequate response to standard therapies, including those who previously received anti-tumour necrosis factor (TNF) alpha biologics.

Meanwhile, Discover-2 enrolled biologic-naive patients with an inadequate response to standard treatments.

In the Discover-1 study, the drug led to ACR20 response in 59% of participants treated every four weeks (q4w) and 52% of those treated at weeks zero and four followed by every eight weeks thereafter (q8w).

The response was observed in 22% of patients in the placebo group.

The trial also analysed the effect of the drug in patients with a >3% body surface area (BSA) affected with psoriasis and an >2 Investigator Global Assessment (IGA) score at baseline.

Data showed 75% of patients on Tremfya q4w and 57% on q8w experienced an IGA score of zero or one and a >2 grade decrease versus 15% with placebo.

In Discover-2, 64% of subjects treated with q4w or q8w dosing regimen had an ACR20 response, compared to 33% receiving placebo.

Compared to 19% of patients in the placebo arm, the IGA score was zero or one in 69% receiving q4w and 71% receiving q8w dosing.

During the trials, adverse events relating to the drug were generally consistent with prior studies.

Janssen Research & Development vice-president Alyssa Johnsen said: “These results from the discover programme represent a major step in the development of Tremfya as a treatment for psoriatic arthritis.”

The drug holds approval in multiple markets, including the US and EU, for the treatment of adults with moderate to severe plaque psoriasis.