학술논문

Efficacy and safety of guselkumab compared with placebo and adalimumab in Korean patients with moderate to severe psoriasis: Post-hoc analysis from the phase Ⅲ, double-blind, placebo- and active comparator-controlled VOYAGE1/2 trials
Document Type
Article
Source
프로그램북(구 초록집). Oct 31, 2018 70(2):402
Subject
Guselkumab
Psoriasis
VOYAGE1
VOYAGE2
Language
Korean
Abstract
Background: The Phase Ⅲ studies, VOYAGE 1 and 2, were conducted to assess guselkumab for the treatment of patients with moderate to severe psoriasis. However, these studies included a worldwide study population. Objectives: To determine the efficacy and safety of guselkumab in Korean patients. Methods: This analysis included 28 patients from VOYAGE 1 and 98 patients from VOYAGE 2. In total, 126 patients were analyzed. Outcomes through week 28 were analyzed due to differences in design after week28. Results: Of 126 Korean patients randomized, 30 received placebo, 63 were assigned to guselkumab, and 33 received adalimumab. Guselkumab was superior to adalimumab in achieving an IGA 0 score (clear skin) at week 12 (31.7% vs 0.0%, p<0.001) and at week 24 (52.4% vs 21.2%, p=0.004), respectively. Among patients treated with guselkumab, 40 of 63 (63.5%) achieved a PASI75 response at week 8; at week 24, a significantly higher proportion of guselkumab patients achieved a PASI 75 compared to adalimumab patients (93.7% vs 66.7%, respectively, p<0.001). In addition, higher proportions of guselkumab patients achieved PASI 90 and PASI 100 than adalimumab patients at week 24 (PASI90; 73.0% vs 57.6%, p=0.168 / PASI100; 20.6% vs 15.2%, p=0.591, respectively). Through week 28, guselkumab and adalimumab showed comparable safety profiles. Conclusion: The efficacy and safety of guselkumab in Korean psoriasis patients through 28 weeks was consistent with findings reported for the VOYAGE1 and 2 trials.

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