Janssen Research and Development, LLC

New Two-year Guselkumab Data Show Patients with Moderate to Severe Plaque Psoriasis Achieved Consistent Rates of Skin Clearance

GENEVA, Switzerland, September 16, 2017 /PRNewswire/ --

More than 80 percent of patients receiving guselkumab, including patients transitioned from HUMIRA^® (adalimumab) to the anti-interleukin (IL)-23 monoclonal antibody, demonstrated PASI 90 and IGA 0/1 scores at week 100  

Janssen Research & Development, LLC (Janssen) presented today new longer-term data from the open-label extension of the VOYAGE 1 trial demonstrating consistent rates of skin clearance with guselkumab treatment through week 100 among patients with moderate to severe plaque psoriasis receiving the subcutaneously administered anti-interleukin (IL)-23 monoclonal antibody.^[1] The longer-term findings from the Phase 3 VOYAGE 1 study, presented at the 26^th European Academy of Dermatology and Venereology (EADV) Congress, showed more than 80 percent of patients receiving guselkumab, including those initially treated with placebo or the anti-tumor necrosis factor (TNF)-alpha agent adalimumab, achieved at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90), or near complete skin clearance, and an Investigator's Global Assessment (IGA) score of cleared (0) or minimal disease (1) at week 100.^[1] The findings, presented during an EADV late-breaker session, follow the recent European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of guselkumab, and the United States Food and Drug Administration (FDA) approval of guselkumab in July.  

"These data show the rates of skin clearance with guselkumab were consistent at weeks 52 and 100 with every eight-week maintenance therapy. These important new findings contribute to the scientific evidence for targeting IL-23 in the treatment of moderate to severe plaque psoriasis," said Professor Chris Griffiths, Foundation Professor of Dermatology at the University of Manchester, UK, VOYAGE 1 study steering committee member. "Also noteworthy is that skin clearance rates in patients transitioned to guselkumab from adalimumab improved and the rates were consistent at weeks 52 and 100."

Results from the open-label extension of the Phase 3 VOYAGE 1 study showed that at week 100, among patients initially randomised to guselkumab, 82.4 percent achieved an IGA score of 0/1 (cleared or minimal disease) and 82.1 percent achieved a PASI 90 score (near complete skin clearance).^[1]  In addition, at week 100, 53.8 percent of patients achieved an IGA score of 0 and 49.0 percent of patients achieved a PASI 100 score.^[1] These measures represent skin completely cleared of plaques and were consistent with PASI 100 and IGA 0 results demonstrated at week 52.^[1] Among patients initially randomised to receive adalimumab and transitioned to guselkumab at week 52, the proportion of patients achieving a PASI 90 score increased from 50.5 percent at week 52 to 81.1 percent at week 100, and the proportion of patients achieving an IGA 0/1 increased from 60.4 percent at week 52 to 84 percent at week 100.^[1]  The proportion of patients who achieved PASI 100 and IGA 0 scores increased from 24.0 percent and 27.3 percent, respectively, at week 52 to 51.6 percent and 55.6 percent, respectively, at week 100.^[1] Results among patients initially randomised to placebo and crossed over to guselkumab at weeks 16 and 20 demonstrated consistent levels of skin clearance at weeks 52 and 100.^[1]