Janssen has presented Phase III data showing that its anti-interleukin (IL)-23 monoclonal antibody was superior to placebo and AbbVie's mega-blockbuster Humira at clearing skin in patients with plaque psoriasis.
Data from the VOYAGE 1 trial showed significantly higher proportions of patients receiving guselkumab achieved cleared/minimal disease compared with patients receiving placebo, as defined by at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90, near complete skin clearance) and an Investigator's Global Assessment (IGA) score of cleared (0) or minimal disease (1) at week 16, the study co-primary endpoints.
The results show that 85.1 percent of patients taking the drug at weeks 0 and 4 and then every eight weeks achieving cleared (IGA 0) or minimal disease (IGA 1) compared with 6.9 percent of patients receiving placebo. Nearly three-quarters of patients (73.3 percent) achieved a PASI 90 response versus 2.9 percent in the placebo arm.
The trial also included an active comparator arm evaluating guselkumab versus tumour necrosis factor blocker Humira (adalimumab). At week 16, following three injections of guselkumab and ten injections of Humira, significantly higher proportions of patients receiving guselkumab achieved IGA 0/1 and PASI 90 (85.1 percent and 73.3 percent, respectively) compared with those taking Humira (65.9 percent and 49.7 percent, respectively).
At week 24, the proportion of patients who achieved a PASI 90 response was significantly higher in the guselkumab group compared with the adalimumab group (80.2 percent vs. 53.0 percent, respectively), and higher levels of skin clearance in those taking Janssen's drug continued through weeks 24 and 48, the firm said.
On the safety side, serious adverse events were reported in 1.7 percent of patients receiving placebo, 2.4 percent of patients receiving guselkumab and 1.8 percent of patients receiving Humira, while the proportions of patients reporting at least one AE were comparable between the two groups at 73.9 percent and 74.5 percent, respectively.
"Results from the VOYAGE 1 study show the promise of guselkumab, an IL-23 inhibitor, as a future therapeutic for plaque psoriasis, an immune-mediated disease," noted Professor Chris Griffiths, Foundation Professor of Dermatology at the University of Manchester and steering committee member.
The findings were presented at the 25th European Academy of Dermatology and Venereology (EADV) Congress; additional data analyses from VOYAGE 1, and results from two other trials in the Phase III programme (VOYAGE 2 and NAVIGATE), will be released at future scientific congresses, Janssen noted.