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( Joo Young Roh ),( Young Lip Park ),( Chun Wook Park ),( Joo Hee Lee ),( Zhen Chen ),( Brad Shumel ),( Ana B. Rossi ) 대한피부과학회 2020 대한피부과학회 학술발표대회집 Vol.72 No.1
Background: Dupilumab provided clinical improvement and favorable safety in patients with moderate-to-severe atopic dermatitis (AD) not controlled with topical medications. Objectives: To evaluate the effect of long-term dupilumab in adult Koreans with moderate-to-severe AD. Methods: LIBERTY AD OLE (NCT01949311) is a phase 3 study assessing 300mg weekly open-label dupilumab in adults with moderate-to-severe AD who previously participated in controlled (parent) studies of dupilumab. Results: 96 Korean patients were treated (65.6% male; mean age 30.2 years). At Week 124 (n=40), 57.5% of patients had Investigator’s Global Assessment ≤1, and 85.0% of patients had ≥75% improvement in Eczema Area and Severity Index (EASI-75); 46.9% had EASI-75 by Week 2 (n=96). Mean percent change of weekly averaged Peak Pruritus Numerical Rating Scale (PP-NRS) from parent study baseline to Week 124 (n=35) was -59.31%. In the total OLE population (n=2,677), 9.6% patients had serious treatment-emergent adverse events (TEAE). Most common TEAEs were nasopharyngitis (28.1%), AD exacerbation (16.4%), upper respiratory tract infection (13.1%), conjunctivitis (9.7%), headache (8.1%), oral herpes (7.0%). There was no increase in TEAE rates or new safety signals compared with the parent studies. Conclusion: Dupilumab treatment provided a sustained, multidimensional control in Korean patients with moderate-to-severe AD with the safety profile supporting dupilumab as long-term treatment option.