Guselkumab displayed long-term efficacy in patients with moderate to severe psoriasis, according to study data published in the Journal of the American Academy of Dermatology. Safety signals were consistent throughout the 3-year treatment period.
Investigators abstracted data from 2 ongoing phase 3 trials of guselkumab: VOYAGE1 and VOYAGE 2. Each trial enrolled adult (≥age 18 years) patients with moderate to severe plaque psoriasis from multiple clinical sites worldwide. In both studies, patients were randomly assigned 2:1:2 to the following treatment arms: (1) guselkumab 100 mg every 8 weeks; (2) placebo; (3) an active comparator (adalimumab) at standard psoriasis dosing. At week 16, patients in the placebo group were crossed over to the guselkumab condition. Patients receiving adalimumab were crossed over to guselkumab at weeks 28 or 52. By week 76, all patients in both studies had received guselkumab every 8 weeks.. Efficacy was assessed using the Investigator’s Global Assessment (IGA) and the Psoriasis Area and Severity Index (PASI). The percentage of patients achieving nearly complete clearance (≥90% improvement in PASI [PASI 90] and IGA score of 0 or 1 [IGA 0/1]) and complete clearance (PASI 100 and IGA 0) by week 156 (year 3) were calculated. Adverse events were evaluated throughout the duration of each trial.
A total of 774 and 947 patients received treatment in VOYAGE 1 and VOYAGE 2, respectively. The percentage of the guselkumab groups achieving nearly complete clearance in VOYAGE 1 and VOYAGE 2, respectively, was 82.8% and 77.2% (PASI 90) and 82.1% and 83.0% (IGA 0/1). Complete clearance per PASI 100 was achieved by 50.8% and 48.8% of the VOYAGE 1 and VOYAGE 2 guselkumab groups, respectively; with IGA 0, the clearance rates were 53.1% and 52.9%. Overall, 3.4% and 4.5% of patients in VOYAGE 1 and VOYAGE 2, respectively, discontinued guselkumab treatment due to adverse events. Of 1721 patients treated with guselkumab, 60 (3.5%) reported injection site reactions. Across both trials, serious adverse events (5.68 per 100 person-years [PY]), serious infections (1.15/100PY), non-melanoma skin cancers (0.28/100PY), malignancies other than non-melanoma skin cancers (0.47/100PY), and major adverse cardiovascular events (0.28/100PY) occurred at relatively low rates. Safety events were consistent throughout the duration of the trials, with no new safety signals observed from years 1 to 3.
In 2 multisite, randomized clinical trials, guselkumab displayed durable efficacy and a consistent safety profile over the course of 3 years. As a study limitation, the investigators noted that neither trial employed a comparator arm beyond year 1; both placebo and adalimumab arms were crossed over to guselkumab by week 76. VOYAGE 1 and VOYAGE 2 will continue to collect data through year 5; the results will further inform the efficacy and safety profile of guselkumab.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures
Reich K, Griffiths CEM, Gordon KB, et al. Maintenance of clinical response and consistent safety profile with up to three years of continuous treatment with guselkumab: results from the VOYAGE 1 and VOYAGE 2 trials [published online December 3, 2019]. J Am Acad Dermatol. doi:10.1016/j.jaad.2019.11.040