杜皮鲁玛
特应性皮炎
医学
内科学
生物标志物
乳酸脱氢酶
胃肠病学
皮肤病科
生物
生物化学
酶
作者
A. Alexis,C. Heath,S.R. Desai,Z. Rice,A.B. Rossi,Z. Chen,F.A. Khokhar,A. Rodríguez Marco,P. Shah
标识
DOI:10.1016/j.reval.2023.103413
摘要
Most clinical atopic dermatitis (AD) studies enroll a higher proportion of White patients (pts), despite clinical presentation and susceptibility variation across racial subgroups. The effect of dupilumab treatment on biomarker levels was assessed across racial subgroups in pediatric populations. This analysis included pts aged 6 months to 17 years with moderate-to-severe AD who participated in one of three randomized, double-blind, placebo (PBO) controlled, phase 3 studies: Pts in LIBERTY AD PRESCHOOL (6 months to 5 years; NCT03346434 part B) were treated with either dupilumab 200/300 mg every 4 weeks (q4w) + topical corticosteroids (TCS; n = 83) or PBO + TCS (n = 79); Pts in LIBERTY AD PEDS (6 years to 11 years; NCT03345914), were treated with dupilumab 100/200 mg every 2 weeks (q2w) + TCS (n = 122), 300 mg q4w + TCS (n = 120) or PBO + TCS (n = 120); In LIBERTY AD ADOL (12 years to 17 years; NCT03054428), pts were treated with dupilumab 200/300 mg q2w (n = 82), dupilumab 300 mg q4w (n = 83) or PBO (n = 85). This post hoc subgroup analysis pooled data for all dupilumab treatment groups. For this analysis, thymus and activation-regulated chemokine (TARC) and lactate dehydrogenase (LDH) were assessed at week 4 and week 16 in each racial subgroup: white (dupilumab: n = 341, PBO: n = 175), black or African American (dupilumab: n = 69, PBO: n = 53), Asian (dupilumab: n = 40, PBO: n = 26) and other (dupilumab: n = 35, PBO: n = 25). Mean percent change in thymus and activation-regulated chemokine (TARC) and lactate dehydrogenase (LDH) were assessed at week 16 with significant (P < 0.0001) changes between dupilumab and PBO noted in TARC in the Asian racial subgroup and LDH in all racial subgroups. The proportion of pts with TEAEs were relatively similar across all racial subgroups: white (dupilumab: 70%, PBO: 77%), black or African American (dupilumab: 52%, PBO: 53%), Asian (dupilumab: 73%, PBO: 73%) and other (dupilumab: 60%, PBO: 84%). Dupilumab treatment demonstrates reductions in biomarker levels across observed racial subgroups in pediatric pts with moderate to severe atopic dermatitis. Overall safety was consistent with the known dupilumab safety profile.
科研通智能强力驱动
Strongly Powered by AbleSci AI