The Janssen Pharmaceutical Companies of Johnson & Johnson has reported that open-label extension data from Phase III VOYAGE 1 trial of Tremfya (guselkumab) showed high rates of skin clearance in patients with plaque psoriasis.
Developed by Janssen, Tremfya is a human monoclonal antibody that selectively attaches to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor.
For the randomised, double-blind, placebo and active comparator-controlled trial, a total of 837 subjects enrolled.
It analysed the efficacy and safety of Tremfya compared with placebo and adalimumab in adults with moderate to severe plaque psoriasis.
The co-primary endpoints of the trial were the number of patients on Tremfya vs placebo achieving Investigator’s Global Assessment (IGA) 0 / 1 (clear / almost clear) and Psoriasis Area Severity Index (PASI) 90 response at week 16.
Efficacy was assessed using Treatment Failure Rules (TFR) for the primary analysis, while Non-Responder Imputation (NRI) and As Observed (OBS) methods were used for the secondary analyses.
In this trial, out of a total of 494 patients either randomised to Tremfya at week 0 or randomised to placebo and crossed over to receive Tremfya at week 16, 76.9% continued on Tremfya treatment through week 252.
At week 252 in the combined Tremfya group, 84% of patients achieved a PASI 90 response and 82.4% achieved an IGA score of 0 or 1.
Among patients in the combined Tremfya group, patients were either initially randomised to Tremfya or placebo with crossover to Tremfya at week 16.
Safety profiles were consistent with the previous data and no new safety signals were observed in the nearly five years of treatment.
Janssen Research & Development Immunodermatology Disease Area Leader vice-president Lloyd Miller said: “We are excited to share these data demonstrating Tremfya’s ability to help adults living with moderate to severe plaque psoriasis by providing sustained rates of clearance through nearly five years for the majority of patients.
“With remission as the ultimate goal, we are committed to continuing to apply the best science and disease insights to advancing therapies that improve the lives of patients.”
Separately, Janssen reported that five-year data from the Phase III IM-UNITI trial of Stelara showed long-term remission in patients with moderate to severe Crohn’s disease (CD).