Phase 3 data for Janssen psoriasis drug shows efficacy over Humira

Janssen has revealed new Phase 3 data for its human monoclonal antibody guselkumab in the treatment of adults with moderate to severe plaque psoriasis, showing the drug to produce significant efficacy compared to Abbvie’s blockbuster drug and market leader Humira (adalimumab).

Subcutaneously administered, guselkumab works by targeting the protein interleukin (IL)-23. The data from both studies showed that treatment with the drug led to "significant improvements" in skin clearance versus placebo and Abbvie’s anti-tumour necrosis factor (TNF)-alpha drug.

"The majority of patients treated with guselkumab achieved high levels of skin improvement at week 16, while this was rarely seen in patients receiving placebo; a difference that was highly significant," explained Kristian Reich, study investigator at Dermatologikum Hamburg. "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."

It also illustrated patients who switched to guselkumab after proving unresponsive to the company’s Stelara (ustekinumab) showed improvement in the disease between weeks 28 and 40 compared to those who did not switch.

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

Janssen R&D’s Head of Immunology Development Newman Yeilding also commented on the significance of the new results for the company: "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. Data from the Phase 3 VOYAGE 2 and NAVIGATE studies continue to demonstrate the potential that guselkumab may offer patients and physicians, and we are committed to working with health authorities around the world on our current and future applications."