New findings from two pivotal Phase 3 studies evaluating the effectiveness and safety of Janssen’ guselkumab for the treatment of moderate to severe plaque psoriasis demonstrated the drug’s superiority compared to Humira (adalimumab).
Also, patients who had an inadequate response to Stelara (ustekinumab) and switched to guselkumab showed a greater improvement than patients who continued taking Stelara, according to the study.
Guselkumab is a subcutaneously administered anti-interleukin (IL)-12/23 monoclonal antibody (mAb) that specifically targets the protein IL-23, a key mediator of inflammation.
The Phase 3 data of the two trials, VOYAGE 2 (NCT02207244) and NAVIGATE (NCT02203032), was presented at the 2017 American Academy of Dermatology Annual Meeting (AAD 2017) March 3-7 in Orlando, Florida.
VOYAGE 2 is the second Phase 3 study to demonstrate the superiority of guselkumab over Humira, following VOYAGE 1 (NCT02207231).
All three Phase 3 VOYAGE 1, VOYAGE 2 and NAVIGATE studies comprise the comprehensive clinical development program evaluating guselkumab in the treatment of moderate to severe plaque psoriasis.
The VOYAGE 2 trial is a randomized, double-blind, placebo- and active-comparator controlled study that enrolled 993 plaque psoriasis patients to assess the safety and effectiveness of guselkumab compared to a placebo and Humira, and of guselkumab maintenance therapy compared to withdrawal of therapy.
The most important findings of VOYAGE 2 were that patients treated with guselkumab experienced significant improvements in skin clearance vs. a placebo and significantly improved results when compared to the anti-tumor necrosis factor (TNF)-alpha treatment Humira.
In total, 70% of patients receiving guselkumab achieved a near complete skin clearance (PASI 90), compared to 2.4% of patients on the placebo. At weeks 16 and 24, 34.1% and 44.2% of patients receiving guselkumab achieved PASI 100 responses, respectively.
“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. Higher rates in efficacy in major secondary endpoints comparing guselkumab with adalimumab [Humiera] were also demonstrated and significant,” Kristian Reich, PhD, MD, study investigator for VOYAGE 2, said in a press release.
“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,” Reich said.
The NAVIGATE study is a randomized, double-blind, multi-center study that enrolled 876 patients to evaluate the effectiveness and safety of guselkumab vs. Stelara plaque psoriasis patients who had inadequate responses to treatment with Stelara.
NAVIGATE showed that patients showed significantly greater improvements in skin clearance after switching to guselkumab compared to patients who continued taking Stelara.
Guselkumab was also shown to be superior to Stelara across major secondary endpoints in this trial, including the number of visits that patients achieved a PASI 90 response.
“Findings from NAVIGATE showed treatment with guselkumab provided significant benefit to patients who were not achieving clear or almost clear skin with ustekinumab treatment,” said Richard Langley, MD, study investigator for NAVIGATE. “These data show the effectiveness of guselkumab in patients who had an inadequate response to treatment with ustekinumab [Stelara] and provide further insights into the therapeutic profile of guselkumab in this patient population.”
Guselkumab is currently under review by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of adults with moderate to severe plaque psoriasis.