Janssen reports positive results from plaque psoriasis trial

14th December 2018 (Last Updated December 14th, 2018 00:00)

Janssen Pharmaceutical Companies of Johnson & Johnson has reported positive results from the Phase III ECLIPSE trial that investigated the efficacy and safety of tremfya (guselkumab) in comparison with cosentyx (secukinumab) in adult patients with moderate to severe plaque psoriasis.

Janssen reports positive results from plaque psoriasis trial
Psoriasis is a painful, debilitating and life-long condition. Credit: Roland Tanglao.

Janssen Pharmaceutical Companies of Johnson & Johnson has reported positive results from the Phase III ECLIPSE trial that investigated the efficacy and safety of tremfya (guselkumab) in comparison with cosentyx (secukinumab) in adult patients with moderate to severe plaque psoriasis.

The results demonstrated that tremfya was more effective than cosentyx in treating patients with plaque psoriasis at week 48.

Data showed that 84.5% of patients receiving tremfya achieved the primary endpoint of a PASI 90 response at week 48 versus 70% of patients receiving cosentyx.

Tremfya also showed non-inferiority to cosentyx in the trial’s first major secondary endpoint, with 84.6% of patients treated with tremfya witnessing a PASI 75 response at both weeks 12 and 48 against 80.2% of the patients treated with cosentyx.

"Not only does this treatment offer patients high levels of skin clearance, but our current three-year data shows a consistent maintenance of efficacy."

However, this difference did not demonstrate superiority and therefore p-values for all the subsequent major secondary endpoints of the trial were considered nominal.

The results also revealed that the safety profiles of tremfya and secukinumab observed in the ECLIPSE trial were similar to those previously observed in the respective registration trials and current prescribing information.

Janssen Therapeutic Europe, Middle East and Africa Immunology area lead Dr Jaime Oliver said: “Psoriasis is a painful, debilitating and life-long condition, and those who suffer from it are in need of treatments that not only work well but work well for a long time.

“The evidence supporting guselkumab shows that not only does this treatment offer patients high levels of skin clearance, but our current three-year data shows a consistent maintenance of efficacy, something we hope to see continue as we gain more data.”

The ECLIPSE trial featured a multicentre, randomised, double-blind, active comparator design that enrolled 1048 patients.

Patients were randomised to receive either 100mg subcutaneous (SC) injection of tremfya at weeks zero and four followed by a maintenance dose every eight weeks, or two SC injections of 300mg Cosentyx at weeks zero, one, two, three, and four, followed by monthly maintenance dosing.