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The Phase III trial examined guselkumab compared with a placebo and Humira at treating moderate-to-severe plaque psoriasis.
Janssen Research and Development announced the results of the first of three Phase III studies involving the company’s guselkumab, an anti-interleukin (IL-23) monoclonal antibody (mAb) for the treatment of patients with moderate-to-severe plaque psoriasis. The results of the VOYAGE 1 trial, released on Oct. 1, 2016, showed that the mAb was superior to Humira (adalimumab) and a placebo across major study endpoints through 48 weeks of treatment. Data from the trial were presented at the European Academy of Dermatology and Venereology Congress.
Trial results showed that at week 24, 80.2% of patients receiving guselkumab achieved a Psoriasis Area Severity Index (PASI) 90 response, versus 53% of patients taking adalimumab. However, trial results showed guselkumab demonstrated a slightly higher instance of adverse events through week 16 of the study, when compared with adalimumab. Through week 48 of the trial, the proportion of patients reporting at least one adverse event was comparable between guselkumab and adalimumab.
“The high and durable rates of response in skin clearance were associated with significant improvements in quality of life among patients treated with guselkumab,” Chris Griffiths, foundation professor of dermatology at the University of Manchester and steering committee member said in a statement. “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.”