Originally Published by Johnson & Johnson.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced new long-term data from the open-label period of the VOYAGE 1 clinical trial demonstrating that stably maintained rates of skin clearance with TREMFYA treatment achieved from week 52 (1 year) were maintained through week 156 (3 years) among adult patients with moderate to severe plaque psoriasis. TREMFYA is the first anti-interleukin (IL)-23 monoclonal antibody that was approved by the U.S. Food and Drug Administration (FDA) and is administered by subcutaneous injection. The findings, presented at the 37th Fall Clinical Dermatology Conference in Las Vegas, Nevada, showed nearly 83 percent of patients receiving TREMFYA in the Phase 3 VOYAGE 1 study maintained at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90) response (near complete skin clearance), and an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal disease (1) at week 156.
“These findings are impressive as they demonstrate consistency in high rates of skin clearance with guselkumab treatment at weeks 48, 100 and 156 with every eight-week maintenance therapy,” said Andrew Blauvelt, M.D., MBA, President, Oregon Medical Research Center, and VOYAGE 1 study steering committee member.* “In the management of moderate to severe plaque psoriasis, including symptom relief as well as skin clearance, it is essential that we continue to evaluate the impact of treatments with long-term data like those presented today. The VOYAGE 1 findings help further our understanding of the long-term impact of targeting IL-23 with guselkumab in the treatment of plaque psoriasis.”
Results from the open-label extension of the VOYAGE 1 Phase 3 clinical study showed that at week 156, in the combined group of patients initially randomized to TREMFYA or to placebo with crossover to TREMFYA at week 16, 82.1 percent achieved an IGA score of 0/1 (cleared or minimal disease), 96.4 percent achieved a PASI 75 score, and 82.8 percent achieved a PASI 90 score.
At week 156, 53.1 percent of patients achieved an IGA score of 0 and 50.8 percent of patients achieved a PASI 100 response. These measures represent skin completely cleared of psoriasis plaques and are consistent with PASI 100 and IGA 0 results demonstrated at week 100.
Responses based on the Psoriasis Symptoms and Signs Diary (PSSD) were consistent at week 100 and week 156 as well. This tool evaluates patient-reported symptoms (i.e., itch, pain, stinging, burning and skin tightness) and signs (i.e., skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The percentage of patients reporting a PSSD symptom score of 0 was 40.2 at week 100 and 40.4 at week 156.
Of the 494 patients in the combined TREMFYA and placebo crossover to TREMFYA group, the percentages of patients reporting adverse events (AEs), serious AEs, infections, and serious infections through week 48 were 70.9 percent, 4.3 percent, 50.2 percent and 0.6 percent, respectively, and through week 100 were 80.0 percent, 9.1 percent, 61.1 percent and 1.2 percent, respectively. Among the same patient group, the percentages of events reported through week 156 were 86.2 percent, 13.4 percent, 67.8 percent and 2.2 percent respectively. No cases of active tuberculosis, opportunistic infections or serious hypersensitivity reactions were reported among TREMFYA-treated subjects.
“We are very pleased and excited by these results. The data adds to the growing body of safety and efficacy evidence with the use of TREMFYA over a three-year period,” said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. “As a part of our commitment to developing innovative therapies for chronic, immune-mediated disease like psoriasis, we have been focusing on generating long-term data so that patients and physicians can be more informed when making treatment decisions.”