Johnson & Johnson subsidiary Janssen has announced results from its phase III Eclipse trial comparing its Tremfya (guselkumab) with Novartis’ Cosentyx (secukinumab) in adults with moderate to severe plaque psoriasis.
Janssen’s drug demonstrated superiority for the primary endpoint at week 48.
The primary endpoint was at least 90% improvement in baseline psoriasis area severity index (PASI) score, referred to as PASI 90. In the trial, 84.5% of those taking Tremfya achieved PASI 90, compared to 70% of those taking Cosentyx.
For the four secondary endpoints at week 48, Tremfya also achieved better results than Cosentyx. The study showed that 84.6% of the Tremfya group achieved PASI 75 at both week 12 and 48, compared to 80.2% for Cosentyx, however, Janssen notes that this did not demonstrate superiority.
Additionally, 58.2% of Tremfya patients achieved PASI 100, compared to 48.2% of Cosenytx patients, and 62.2% of the Tremfya group had an Investigator’s Global Assessment (IGA) score of 0, and 87% had a score of 0 or 1, compared to 50.4% with an IGA of 0 and 74.9% with an IGA of 0 or 1 for the Cosentyx group.
The final endpoint was non-inferiority of Tremfya at week 12; at this point, Cosentyx demonstrated superiority to Janssen’s drug. The results showed 91.6% of the Cosentyx group achieved PASI, compared to 89.3% for Tremfya, and 76.1% of Cosentyx achieved PASI 90, compared to 69.1% for Tremfya group.
Eclipse study lead investigator Richard Langley said: “The response-over-time curves show that maximum response rates with Tremfya are achieved after six months and are maintained over time through one year, achieving superiority at the primary endpoint of the study.”
“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.”
This is the first head-to-head phase III study comparing these two drugs; Tremfya is an interleukin (IL)-23 inhibitor, while Cosentyx is an IL-17 inhibitor.
Novartis are carrying out its own comparator trial over 16 weeks; the results are expected in 2019.
Cosentyx was approved for plaque psoriasis by the US Food and Drug Administration in 2015, and Tremfya followed in 2017.