|The following article is part of conference coverage from the 2018 Fall Clinical Dermatology Conference in Las Vegas, Nevada. Dermatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in dermatology. Check back for the latest news from Fall Clinical Derm 2018.|
New findings from the VOYAGE 1 trial (N=837) presented at the 2018 Fall Clinical Dermatology Conference demonstrated that stably maintained rates of skin clearance achieved with guselkumab (Tremfya®; Janssen) at week 52 were maintained through week 156 among adults with moderate to severe plaque psoriasis.
The phase 3 randomized, double-blind, placebo-active comparator-controlled trial evaluated the safety and efficacy of guselkumab with placebo and adalimumab in adults with moderate to severe plaque psoriasis.
Long-term data from the open-label period showed that in the combined group of patients who initially received guselkumab or placebo with a crossover to guselkumab at week 16, 82.1% achieved an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal disease (1), 96.4% achieved at least a 75% improvement in the Psoriasis Area Severity Index (PASI 75) response, and 82.8% achieved at least a 90% improvement in the PASI response (PASI 90).
At week 156 (year 3), 53.1% of patients achieved an IGA score of 0 and 50.8% of patients achieved a PASI 100 response, indicating complete clearance of psoriasis plaques. The data were consistent with PASI 100 and IGA 0 findings seen at week 100.
Moreover, the patients’ responses based on the Psoriasis Symptoms and Signs Diary (PSSD) that evaluated patient-reported signs and symptoms (eg, skin dryness, cracking, scaling, shedding or flaking, redness, bleeding, itch, pain, stinging, burning, skin tightness) were consistent at both weeks 100 and 156. Specifically, 40.2% of patients reported a PSSD symptom score of 0 at week 100 and 40.4% of patients at week 156.
Regarding safety, the percentages of patients reporting adverse events (AEs), serious AEs, infections, and serious infections through week 156 were 86.2%, 13.4%, 67.8%, and 2.2%, respectively.
Tremfya, a human anti-interleukin (IL)-23 monoclonal antibody, is a subcutaneous injection currently approved to treat adults with moderate to severe plaque psoriasis who may benefit from taking systemic therapy or phototherapy.
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Janssen announces new three-year Tremfya® (guselkumab) data demonstrates stably maintained rates of skin clearance in patients with moderate to severe plaque psoriasis [news release]. Las Vegas, NV: Janssen Pharmaceutical Companies of Johnson & Johnson. Accessed October 19, 2018. https://www.prnewswire.com/news-releases/janssen-announces-new-three-year-tremfya-guselkumab-data-demonstrates-stably-maintained-rates-of-skin-clearance-in-patients-with-moderate-to-severe-plaque-psoriasis-300734035.html