Janssen reports positive long-term Phase III data of Tremfya for plaque psoriasis

19th September 2017 (Last Updated September 19th, 2017 18:30)

Janssen Research & Development has reported new positive two-year results from the open-label extension of the Phase III VOYAGE 1 trial of Tremfya (Guselkumab) to treat moderate-to-severe plaque psoriasis.

Janssen Research & Development has reported new positive two-year results from the open-label extension of the Phase III VOYAGE 1 trial of Tremfya (Guselkumab) to treat moderate-to-severe plaque psoriasis.

Tremfya is a human monoclonal antibody designed to selectively block the protein interleukin (IL)-23.

The longer-term data indicated consistent rates of skin clearance through week 100 in more than 80% of patients, including those who switched from the anti-tumour necrosis factor (TNF)-alpha agent Humira (adalimumab).

With a total of 837 adult subjects, the randomised, double-blind, placebo and active comparator-controlled Phase III trial assessed the safety and efficacy of Tremfya over 100 weeks, compared to placebo and adalimumab.

Patients initially administered with adalimumab were later switched to Tremfya.

The trial’s co-primary endpoints of the study were comparison of proportion of patients receiving Tremfya and those given placebo in achieving investigator’s global assessment cleared / minimal disease (iga 0/1) score and psoriasis area severity index (PASI 90) response.

"We look forward to continued collaborations with regulators as we work to bring Tremfya to patients around the world who may benefit from this novel therapy."

The ongoing open-label extension period of the trial was initiated at week 52.

Janssen Research & Development immunology development head Newman Yeilding said: “We are committed to advancing innovative therapies for immune-mediated diseases, like psoriasis, as we seek to improve outcomes for patients.

“We look forward to continued collaborations with regulators as we work to bring Tremfya to patients around the world who may benefit from this novel therapy.”

According to the latest data, at week 100 an IGA 0/1 score was achieved in 82.4% of patients and PASI 90 score in 82.1%, while 53.8% of patients achieved an IGA score of 0 and 49% achieved a PASI 100 score.

The results were found to be consistent with those observed at week 52, with an increase from 50.5% to 81.1% at week 100 in a proportion of patients achieving a PASI 90 score after transitioning from adalimumab.

In case of a proportion of patients achieving an IGA 0/1, the increase was from 60.4% at week 52 to 84% at week 100.