PracticeUpdate Conference Series World Congress of Dermatology 2019

Guselkumab Durably Effective in Psoriasis Patients After 3-Year Follow-Up Response rates were similarly high inmultiple subgroups of patients.

P atients with moderate-to-severe plaque pso- riasis maintain a consistent response to the anti-interleukin-23 human monoclonal anti- body guselkumab over 3 years, despite differences in background demographics, according to data from the ongoing VOYAGE 1 and 2 trials. Study investigators determined that psoriasis patients maintained a durable and consistent clinical response to guselkumab over 3 years of follow-up despite differences in gender, age, body weight and race. In both the VOYAGE 1 (n=837) and VOYAGE 2 (n=992), a pair of ongoing placebo/active com- parator-controlled phase III trials, patients were randomized to receive either guselkumab 100 mg at weeks 0, 4, and 12, then every 8 weeks; placebo at weeks 0, 4, and 12, followed by guselkumab at weeks 16 and 20, then every 8 weeks; or adali- mumab 80 mg at week 0, adalimumab 40 mg at week 1, and 40 mg again every 2 weeks until either week 47 (VOYAGE 1) or week 23 (VOYAGE 2). During weeks 52 to 156, all patients in VOYAGE 1 received open-label guselkumab 100 mg every 8 weeks. Patients in VOYAGE 2 received open-label guselkumab during weeks 76 to 156 using a rand- omized withdrawal study design.

Efficacy was assessed in VOYAGE 1 and 2 using prespecified treatment-failure rules, which were a composite of nonresponder status after discontin- uing for lack of efficacy, psoriasis worsening, and prohibited treatment. The total Investigator Global Assessment (IGA) 0/1 response rate was 83.1% at week 100 and 82.6% at week 156. Similar response rates were observed in various demographic subgroups, including men (82.8% at week 100 and 81.1% at week 156), women (83.9% at week 100 and 86.6% at week 156), patients younger than 45 years (83.5% at week 100 and 82.3% at week 156), patients 45 to 65 years of age (83.3% at week 100 and 84.9% at week 156), and patients ≥65 years of age (77.4% at week 100 and 66.0% at week 156). Neither body weight nor race significantly affected response rates. Patients weighing ≤90 kg experi- enced response rates of 86.9% at week 100 and 88.0% at week 156, whereas patients weighing >90 kg experienced response rates of 78.0% at week 100 and 75.4% at week 156. Similarly, response rates for Asian patients were 76.1% at week 100 and 78.1% at week 156, whereas response rates for white patients were 84.0% at week 100 and 83.4% at week 156. “We actually don't think any of these differences are statistically significant, so the conclusion is that regardless of gender, age, body weight, or race, there are durable and consistent responses out to 3 years,” study lead investigator and presenter Andrew Blauvelt, MD, of the Oregon Medical Research Center in Portland, told Elsevier’s PracticeUpdate. “The two most important themes of this study are durability, that the responses stayed durable over 3 years, because that is a common issue that arises with biologic therapy; over time, often patients will lose response,” Dr. Blauvelt said. “The second major point of this study is that it is highly encour- aging that efficacy was maintained over 3 years among the heaviest patients, 75.4%, which is still a great IGA 0/1 response, so that is actually a really positive number. “Continued safety is another important thing that practicing dermatologists worry about,” Dr. Blauvelt added. “No new safety issues were identified. “The study will continue for 5 years, so it will be interesting to see if this durability is maintained over an additional 2 years,” he concluded.

Dr. Andrew Blauvelt

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