- Fresh head-to-head clinical data shows Johnson & Johnson's Tremfya edging out Novartis' Cosentyx, a key rival therapy, in treating plaque psoriasis over 48 weeks, J&J's subsidiary Janssen said Wednesday.
- A Phase 3 study pitted the two therapies against each other, measuring the effect of each on treating moderate-to-severe plaque psoriasis through 48 weeks. J&J's drug showed a statistically significant advantage over Novartis' on the study's primary goal, with about 85% of those given Tremfya achieving at least a 90% improvement in their baseline Psoriasis Area Severity Index scores compared to 70% of those in the Cosentyx arm.
- However, Tremfya failed to demonstrate statistical superiority on the study's first secondary endpoint of at least a 75% reduction at both weeks 12 and 48 — rendering subsequent secondary data nominal. Within those results, interestingly, Cosentyx showed slightly better response rates after 12 weeks than Tremfya.
In a crowded market for plaque psoriasis, the big pharmas have bet on head-to-head studies to differentiate their treatments.
While the Janssen trial focused on which product was better at clearing skin after 48 weeks, some of its secondary endpoints compared the two drugs after 12 weeks.
Overall, Tremfya (guselkumab) demonstrated superiority to Cosentyx (secukinumab) after 48 weeks in the ECLIPSE study. That's a win for J&J, as the lead study investigator said the data showed Tremfya hitting its "maximum response rates" after six months.
Yet the 12-week data showed Cosentyx came out on top — at least numerically so — with 76% of Cosentyx patients achieving at least a 90% reduction compared to 69% of the Tremfya arm.
"Results of the study confirm a slightly more rapid onset of response with Cosentyx, but importantly, in a chronic disease like psoriasis, these data provide new insights into comparative longer-term efficacy," said the investigator, Richard Langley of Dalhousie University, in a statement provided by J&J.
The new results suggest both drugmakers designed their trials to play to the strengths of their therapies. While J&J's study measured longer-term efficacy, with the primary endpoint set after 48 weeks of treatment, Novartis set its trial to run over a shorter timeframe of 16 weeks.
The Swiss drugmaker expects to provide trial results sometime next year. If the 12-week data from ECLIPSE are anything to go by, Cosentyx has a chance to come out on top there.
While the two drugs are both approved to treat plaque psoriasis, they target different interleukins, which are proteins that regulate immune response. Cosentyx is an IL-17 inhibitor while Tremfya targets IL-23.
The Food and Drug Administration OK'd Tremfya in July 2017, while Cosentyx secured an approval in January 2015. Novartis' drug has enjoyed a strong launch since then, posting $2 billion in sales through the first nine months of 2018, up about 40% from that same time range a year ago.
Tremfya isn't J&J's only competitor to Cosentyx. Stelara (ustekinumab), an IL-12 and IL-23 antagonist, predates Novartis' treatment with an initial approval in 2009, and outsells it as well, notching $3.7 billion in sales through the first three quarters of 2018.
In January, Novartis released additional head-to-head clinical data showing Cosentyx was better at treating plaque psoriasis than Stelara after 12 weeks, adding to a previous study that demonstrated superiority at 52 weeks.
Janssen presented the trial data Wednesday at the Inflammatory Skin Disease Summit in Vienna.