J&J touts Tremfya win in Humira-resistant psoriatic arthritis patients amid showdown with AbbVie's Skyrizi

Tremfya
Johnson & Johnson showed its IL-23 inhibitor Tremfya could help psoriatic arthritis patients who didn't achieve an adequate response from anti-TNF blockers such as AbbVie's Humira. (Johnson & Johnson)

Johnson & Johnson’s Tremfya is relatively new to the psoriatic arthritis race, where multiple players are vying for market share. Facing a new high-profile in-class rival from AbbVie, the New Jersey pharma is building its case against older agents.

In patients who still suffered from active psoriatic arthritis despite previous treatment with anti-TNF agents—including AbbVie’s Humira—Tremfya significantly improved joint symptoms and cleared the skin in more patients than placebo did after six months of treatment.

Investigators presented the readout, from the phase 3b Cosmos trial, at the virtual EULAR meeting. It marked the first time that a selective IL-23 inhibitor worked in this difficult-to-treat TNF inhibitor-resistant patient population, J&J said.

Tremfya helped 44.4% of patients achieve at least 20% improvement in the American College of Rheumatology (ACR) criteria, a composite measurement of joint health, after 24 weeks. In comparison, only 19.8% of patients who received a placebo could say the same. The J&J drug also helped more patients improve at least 50% on the ACR score, as well as in physical function and general health outcomes.

On the skin clearance marker, 30.8% of Tremfya takers enjoyed completely clear skin, or a 100% improvement in the commonly used PASI score for psoriasis severity, compared with only 3.8% of patients in the placebo group.

RELATED: Challenging AbbVie and Lilly in psoriatic arthritis, J&J touts 2-year data for Tremfya

Tremya only entered the psoriatic arthritis space a year ago and is fighting for a place among a long list of competitors including Humira and newer biologics such as Novartis’ IL-17A antagonist Cosentyx, Eli Lilly’s IL-17A med Taltz and J&J’s own IL-12/23 inhibitor Stelara. Oral options such as Pfizer’s JAK inhibitor Xeljanz and Amgen’s Otezla are also vying for market share.

As if the space wasn’t already crowded enough, AbbVie—as part of a succession plan for megablockbuster Humira's patent cliff—is angling two new immunology agents for the same field. One of them, Skyrizi, is also an IL-23 inhibitor that’s working toward its own nods in psoriatic arthritis. AbbVie filed with the FDA and the European Medicines Agency in early April.

Skyrizi’s been turning up stronger-than-expected sales since its 2019 go-ahead in plaque psoriasis, a field where it’s already jostling against Tremfya. In a December update, AbbVie has put the peak sales estimate for Skyrizi in the core psoriatic arthritis and plaque psoriasis indications at $5.5 billion.

RELATED: AbbVie's big Rinvoq ambitions hit an FDA snag as JAK safety questions persist

In the first quarter of 2021, Skyrizi sales nearly doubled to $574 million. By contrast, J&J's earlier-to-market Tremfya, even with the extra indication of psoriatic arthritis, racked up global sales of $418 million.

The other new AbbVie drug, Rinvoq, an in-class rival to Xeljanz, is facing a delay at the FDA for its psoriatic arthritis review. After a heart safety signal from Xeljanz earlier this year, the agency’s taking extra caution with the entire JAK class and delayed several decisions for drugs with that mechanism of action.