Dupilumab treatment reduces caregiver-reported skin pain in patients with moderate-to-severe atopic dermatitis aged 6 months to 5 years

被引:0
|
作者
Paller, Amy S. [1 ,2 ]
Silverberg, Jonathan I. [3 ]
Gonzalez, Mercedes E. [4 ,5 ]
Schneider, Lynda C. [6 ,7 ]
Sidbury, Robert [8 ,9 ]
Chen, Zhen [10 ]
Bansal, Ashish [10 ]
Wang, Zhixiao [10 ]
Prescilla, Randy [11 ]
机构
[1] Northwestern Univ, Dept Dermatol & Pediat, Feinberg Sch Med, Chicago, IL 60611 USA
[2] Ann & Robert H Lurie Childrens Hosp, Div Dermatol, Chicago, IL 60611 USA
[3] George Washington Univ, Sch Med & Hlth Sci, Dept Dermatol, Washington, DC USA
[4] Pediat Skin Res, Coral Gables, FL USA
[5] Univ Miami, Phillip Frost Dept Dermatol, Miller Sch Med, Miami, FL USA
[6] Boston Childrens Hosp, Div Immunol, Boston, MA USA
[7] Harvard Med Sch, Boston, MA USA
[8] Univ Washington, Sch Med, Dept Pediat, Div Dermatol, Seattle, WA USA
[9] Seattle Childrens Hosp, Seattle, WA USA
[10] Regeneron Pharmaceut Inc, Tarrytown, NY USA
[11] Sanofi, Cambridge, MA USA
来源
FRONTIERS IN PEDIATRICS | 2024年 / 12卷
关键词
children; atopic dermatitis; skin pain; efficacy; dupilumab; PLACEBO; MANAGEMENT; CHILDREN; TRIALS;
D O I
10.3389/fped.2024.1446779
中图分类号
R72 [儿科学];
学科分类号
100202 ;
摘要
Background Moderate-to-severe atopic dermatitis (AD) often has a profound impact on the quality of life of young children and their caregivers. One of the most burdensome symptoms reported by patients is skin pain. Methods This post hoc analysis focuses on the impact of dupilumab treatment on skin pain in young children using data from the LIBERTY AD PRESCHOOL part B (NCT03346434), a 16-week randomized, double-blind, placebo-controlled, phase 3 study in 162 children aged 6 months to 5 years with moderate-to-severe AD receiving dupilumab or placebo, plus topical corticosteroids (TCS). Analyses were performed on the full analysis set and subgroups of patients who did not achieve an Investigator's Global Assessment score of 0 or 1 (IGA >1 subgroup), or who did not achieve a 75% improvement from baseline in the Eczema Area and Severity Index ( Results At week 16, change from baseline in the skin pain NRS was significantly greater in the dupilumab group vs. the placebo group (-3.93 vs. -0.62, p < 0.0001) and significantly more patients receiving dupilumab vs. placebo achieved a clinically meaningful improvement at week 16 (47.2% vs. 10.8%, p < .0001). Similar results between dupilumab vs. placebo were seen in the two subgroups IGA >1 and Conclusions This analysis showed rapid, clinically meaningful, and statistically significant improvements in skin pain in patients treated with dupilumab plus TCS vs. placebo plus TCS.
引用
收藏
页数:7
相关论文
共 50 条
  • [41] Treatment-emergent adverse events in patients aged 6 months to 5 years with moderate-to-severe atopic dermatitis treated with dupilumab in an open-label extension clinical trial
    Paller, Amy S.
    Siegfried, Elaine C.
    Sidbury, Robert
    Lockshin, Benjamin
    Cork, Michael
    Pinter, Andreas
    Xiao, Jing
    Khokhar, Faisal A.
    Bansal, Ashish
    Prescilla, Randy
    BRITISH JOURNAL OF DERMATOLOGY, 2023, 188
  • [42] LONG-TERM DUPILUMAB TREATMENT IS NOT ASSOCIATED WITH AN INCREASED OVERALL RISK OF INFECTIONS IN PATIENTS AGED 6 MONTHS TO 5 YEARS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS IN AN OPENLABEL EXTENSION STUDY
    Paller, Amy S.
    Ramien, Michele
    Cork, Michael J.
    Simpson, Eric L.
    Lee, Lara Wine
    Eichenfield, Lawrence F.
    Coleman, Anna
    Gherardi, Guy
    Tian, Tingting
    Zhang, Annie
    Cyr, Sonya L.
    ACTA DERMATO-VENEREOLOGICA, 2023, 103 : 54 - 54
  • [43] DUPILUMAB TREATMENT RAPIDLY IMPROVES ITCH IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
    Silverberg, J.
    Chao, J.
    Eckert, L.
    Chen, Z.
    Ardeleanu, M.
    Shumel, B.
    Plaum, S.
    Graham, N.
    Pirozzi, G.
    Gadkari, A.
    ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY, 2017, 119 (05) : S95 - S95
  • [44] Dupilumab Treatment Rapidly Improves Itch in Patients With Moderate-to-Severe Atopic Dermatitis
    Silverberg, Jonathan I.
    Chao, Jingdong
    Eckert, Laurent
    Chen, Zhen
    Ardeleanu, Marius
    Shumel, Brad
    Plaum, Stefan
    Graham, Neil M. H.
    Pirozzi, Gianluca
    Gadkari, Abhijit
    JOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT, 2018, 16 : 29 - 29
  • [45] Dupilumab treatment restores skin barrier function in adult and adolescent patients with moderate-to-severe atopic dermatitis
    Goleva, E.
    Bissonnette, R.
    Berdyshev, E.
    Jurvilliers, P.
    Agueusop, I.
    Praestgaard, A.
    Levit, N. A.
    Rossi, A.
    Zhang, A.
    JOURNAL OF INVESTIGATIVE DERMATOLOGY, 2022, 142 (08) : S51 - S51
  • [46] Dupilumab Improves Skin Lipid Barrier in Pediatric Patients With Moderate-to-Severe Atopic Dermatitis
    Bronova, Irina
    Berdyshev, Evgeny
    Goleva, Elena
    Danby, Simon
    Bronoff, Anna Sofia
    Richers, Brittany
    Garcia, Shannon
    Gama, Marco Ramirez
    Taylor, Patricia
    Zahn, Joseph
    Agueusop, Inoncent
    Bafna, Shantanu
    Boguniewicz, Mark
    Ong, Peck
    Zhang, Annie
    Cork, Michael
    Leung, Donald
    JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 2024, 153 (02) : AB5 - AB5
  • [47] Dupilumab provides improvement in sleep in children aged ≥ 6 years with severe atopic dermatitis (AD) and adolescents with moderate-to-severe AD
    Paller, A.
    Wollenberg, A.
    Simpson, E.
    Beck, L.
    Hong, C-H
    Marcoux, D.
    Chen, Z.
    Levit, N.
    Bansal, A.
    Rossi, A.
    Chao, J.
    BRITISH JOURNAL OF DERMATOLOGY, 2021, 185 : 57 - 58
  • [48] Dupilumab significantly improves skin barrier function in patients with moderate-to-severe atopic dermatitis
    Berdyshev, Evgeny
    Goleva, Elena
    Bissonnette, Robert
    Bronova, Irina
    Bronoff, Anna Sofia
    Richers, Brittany N.
    Garcia, Shannon
    Ramirez-Gama, Marco
    Taylor, Patricia
    Praestgaard, Amy
    Agueusop, Inoncent
    Jurvilliers, Pauline
    Boguniewicz, Mark
    Levit, Noah A.
    Rossi, Ana B.
    Zhang, Annie
    Leung, Donald Y. M.
    ALLERGY, 2022, 77 (11) : 3388 - 3397
  • [49] Psoriasiform dermatitis during dupilumab treatment for moderate-to-severe atopic dermatitis in children
    Parker, Jennifer J.
    Sugarman, Jeffrey L.
    Silverberg, Nanette B.
    Gonzalez, Mercedes Elena
    Ramien, Michele L.
    Teng, Joyce M. C.
    Paller, Amy S.
    PEDIATRIC DERMATOLOGY, 2021, 38 (06) : 1500 - 1505
  • [50] Laboratory Safety from a Randomized 16-Week Phase III Study of Dupilumab in Children Aged 6 Months to 5 Years with Moderate-to-Severe Atopic Dermatitis
    Paller, Amy S.
    Siegfried, Elaine C.
    Cork, Michael J.
    Wollenberg, Andreas
    Arkwright, Peter D.
    Gonzalez, Mercedes E.
    Lockshin, Benjamin
    Chen, Zhen
    Bansal, Ashish
    Levit, Noah A.
    Prescilla, Randy
    PEDIATRIC DRUGS, 2023, 25 (01) : 67 - 77