作者
J.I. Silverberg,K. Papp,Pablo de la Cueva,H. Zhang,Ainara Rodríguez Marco,Noah A Levit
摘要
Adult-onset AD accounts for ∼25% of adult patients (pts) and is described to have clinical characteristics distinct from childhood-onset AD. To report dupilumab efficacy in adults with moderate-to-severe AD, stratified by age of AD onset. In LIBERTY AD SOLO 1 and 2 (NCT02277743, NCT02277769), 2 identically designed phase 3 trials, 1379 pts aged ≥ 18 years with moderate-to-severe AD received subcutaneous dupilumab 300 mg every 2 weeks (q2w) or weekly (qw), or placebo (PBO) qw, for 16 weeks. Least squares (LS) mean percent change (standard deviation [SD]) from baseline (BL) in Eczema Area and Severity Index (EASI) and weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) scores in pts who received dupilumab q2w (n = 457) vs. PBO (n = 460) by age of AD onset are reported. Age of AD onset was self-reported; P values compared to the corresponding PBO are nominal: **P < 0.01, ***P < 0.001, ****P < 0.0001. In the dupilumab/PBO groups, mean age and duration of AD were 38.3/38.4 years and 27.9/28.8 years, respectively. BL distribution of age of AD onset (n [%]) in the < 5 years, 5–9 years, 10–19 years and ≥ 20 years age groups was 239 (52.3)/249 (54.1), 61 (13.3)/67 (14.6), 63 (13.8)/60 (13.0) and 91 (19.9)/79 (17.2), respectively, for the dupilumab/PBO arms. Disease severity measured by mean EASI and mean weekly PP-NRS showed high consistency at baseline across age of onset groups. At week 16, statistically significant improvements in EASI and PP-NRS scores were observed in the dupilumab vs. PBO groups in all age of onset groups: EASI, −69.7**** vs. −32.0, −65.8*** vs. −37.5, −70.0**** vs. −35.0, −70.4**** vs. −38.7; PP-NRS, −48.3**** vs. −18.6, −46.0** vs. −25.3, −39.3** vs. −18.3, −46.0**** vs. −19.1. Dupilumab was generally well tolerated, with an acceptable safety profile. Dupilumab is efficacious in adults regardless of age at AD onset. Approximately 1 in 5 adults reported onset of AD in adulthood. Total EASI scores were comparable by age of onset, and dupilumab had similar efficacy on EASI and PP-NRS scores during 16 weeks of treatment.