The phase 3 trial, called ECLIPSE, enrolled 1048 patients to evaluate the efficacy and safety of Tremfya in comparison to Cosentyx.
While Tremfya is an interleukin (IL)-23-targeted biologic therapy, Cosentyx is an IL-17 inhibitor owned by Novartis, which was approved in the US in January 2015 for the treatment of plaque psoriasis.
Janssen revealed that 84.5% of patients, who were subjected to Tremfya, had shown an improvement of at least 90% in their baseline Psoriasis Area Severity Index (PASI) score at week 48. This was in comparison to 70.0% of patients on treatment with Cosentyx.
The primary endpoint of the late-stage study was the proportion of patients registering a PASI 90 response at week 48. ECLIPSE defined six key secondary endpoints that used a fixed statistical sequence procedure to control for different comparisons and included shorter and longer-term analyses.
In the first major secondary endpoint, Tremfya was shown to be non-inferior to Cosentyx, with 84.6% of patients on the Janssen drug achieving a PASI 75 response at weeks 12 and 48 compared to 80.2% of those on Cosentyx. However, Tremfya could not demonstrate superiority, said Janssen for that particular secondary endpoint.
The Johnson & Johnson (J&J) subsidiary said that as superiority was not shown for the first major secondary endpoint, p-values for all the following major secondary endpoints were considered nominal.
Janssen Research & Development immunology development head Newman Yeilding said: “Fortunately for patients, there are many good treatment options available for plaque psoriasis today. However, to make the best recommendation for their patients from among these options, physicians need long term comparative safety and efficacy data.
“We’re proud to have conducted this important trial to help guide clinical practice and continue to build on the robust database of clinical information that we’ve been able to generate on Tremfya, the first IL-23 inhibitor.”
Tremfya is approved in the US and Europe for the treatment of adults with moderate to severe plaque psoriasis.