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March 3, 2017

Janssen Research & Development, LLC has announced new findings from two pivotal Phase 3 studies reporting the safety and efficacy of guselkumab in the treatment of adults with moderate to severe plaque psoriasis. Data from the VOYAGE 2 study showed that patients treated with guselkumab experienced substantial improvements in skin clearance and other measures of disease activity compared with placebo, and significantly greater improvements compared with the anti-tumor necrosis factor (TNF)-alpha treatment Humira® (adalimumab). Data from a third Phase 3 study (NAVIGATE) showed that patients who had an inadequate response following treatment with the anti-interleukin (IL)-12/23 monoclonal antibody (mAb) STELARA® (ustekinumab) and who then switched to guselkumab, showed significantly greater improvements in skin clearance compared with patients who continued to receive STELARA®.

Kristian Reich, Ph.D., M.D., Dermatologikum Hamburg, VOYAGE 2 study investigator, said: “The majority of patients treated with guselkumab achieved high levels of skin improvement (more than 80 percent IGA 0/1 and nearly 70 percent PASI 90) at week 16, while this was rarely seen in patients receiving placebo (less than 10 percent); a difference that was highly significant.  Higher rates in efficacy in major secondary endpoints comparing guselkumab with adalimumab were also demonstrated and significant. These findings are consistent with the previously presented Phase 3 VOYAGE 1 study results and further demonstrate the important role of selectively targeting IL-23 in an immune-mediated disease like plaque psoriasis.”

“Findings from NAVIGATE showed treatment with guselkumab provided significant benefit to patients who were not achieving clear or almost clear skin with STELARA® treatment. These data show the effectiveness of guselkumab in patients who had an inadequate response to treatment with STELARA®and provide further insights into the therapeutic profile of guselkumab in this patient population,” said Richard Langley, M.D., FRCPC, Professor, Division of Clinical Dermatology & Cutaneous Science, Department of Medicine, Dalhousie University.

“At Janssen, we are committed to building upon our understanding of psoriasis and bringing forward innovative therapies that continue to meet the needs of people living with immune-mediated diseases like psoriasis,” said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC.

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