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Efficacy and safety of etanercept in children and adolescents aged > or = 8 years with severe plaque psoriasis.
Eur J Dermatol. 2010 May-Jun; 20(3):323-8.EJ

Abstract

Etanercept, a fully human soluble tumor necrosis factor (TNF)-alpha receptor, is approved in Europe for treatment of severe plaque psoriasis in children > or = 8 years. The efficacy and safety of etanercept for this population was evaluated in a retrospective analysis of a previous study, which included 211 children (4-17 years) with psoriasis involving > or = 10% body surface area and Psoriasis Area and Severity Index (PASI) > or = 12. In this subanalysis, subjects aged 8-17 years received once-weekly subcutaneous etanercept 0.8 mg/kg (< or = 50 mg) or placebo in double-blind fashion for 12 weeks, followed by 24 weeks of open-label etanercept. Baseline demographics and disease characteristics were similar across treatment arms (etanercept n = 95, placebo n = 97). At week 12, 54.7% subjects receiving etanercept versus 11.3% receiving placebo achieved 75% or greater improvement in PASI (PASI 75) compared with baseline (p < 0.001). PASI 50, PASI 90, and static Physician Global Assessment of psoriasis followed a similar pattern (p < 0.001). Efficacy during the open-label phase was sustained through Week 36. Exposure-adjusted rates of adverse events for etanercept were similar or lower than those for placebo. No appreciable differences were noted in the efficacy and safety profiles between the subjects aged > or = 8 years in this analysis and those in the original study population aged 4-17 years. In conclusion, etanercept provided significant, sustained improvement in disease severity and was well tolerated in children > or = 8 years with severe plaque psoriasis.

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Publisher Full Text

Authors+Show Affiliations

Landells I
Nexus Clinical Research, St. John's, Newfoundland, Canada.
Paller AS
No affiliation info available
Pariser D
No affiliation info available
Kricorian G
No affiliation info available
Foehl J
No affiliation info available
Molta C
No affiliation info available
Freundlich B
No affiliation info available

MeSH

AdolescentChildChild, PreschoolDisease ProgressionDose-Response Relationship, DrugDouble-Blind MethodEtanerceptFemaleFollow-Up StudiesHumansImmunoglobulin GImmunologic FactorsInjections, SubcutaneousMalePsoriasisReceptors, Tumor Necrosis FactorRetrospective StudiesSeverity of Illness IndexSkinTime FactorsTreatment OutcomeTumor Necrosis Factor-alpha

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20185386

Clinical Trial Links

Etanercept (Enbrel®) in Psoriasis - Pediatrics

Citation

Landells, Ian, et al. "Efficacy and Safety of Etanercept in Children and Adolescents Aged > or = 8 Years With Severe Plaque Psoriasis." European Journal of Dermatology : EJD, vol. 20, no. 3, 2010, pp. 323-8.
Landells I, Paller AS, Pariser D, et al. Efficacy and safety of etanercept in children and adolescents aged > or = 8 years with severe plaque psoriasis. Eur J Dermatol. 2010;20(3):323-8.
Landells, I., Paller, A. S., Pariser, D., Kricorian, G., Foehl, J., Molta, C., & Freundlich, B. (2010). Efficacy and safety of etanercept in children and adolescents aged > or = 8 years with severe plaque psoriasis. European Journal of Dermatology : EJD, 20(3), 323-8. https://doi.org/10.1684/ejd.2010.0911
Landells I, et al. Efficacy and Safety of Etanercept in Children and Adolescents Aged > or = 8 Years With Severe Plaque Psoriasis. Eur J Dermatol. 2010 May-Jun;20(3):323-8. PubMed PMID: 20185386.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of etanercept in children and adolescents aged > or = 8 years with severe plaque psoriasis. AU - Landells,Ian, AU - Paller,Amy S, AU - Pariser,David, AU - Kricorian,Gregory, AU - Foehl,Joanne, AU - Molta,Charles, AU - Freundlich,Bruce, Y1 - 2010/02/25/ PY - 2010/2/27/entrez PY - 2010/2/27/pubmed PY - 2010/7/30/medline SP - 323 EP - 8 JF - European journal of dermatology : EJD JO - Eur J Dermatol VL - 20 IS - 3 N2 - Etanercept, a fully human soluble tumor necrosis factor (TNF)-alpha receptor, is approved in Europe for treatment of severe plaque psoriasis in children > or = 8 years. The efficacy and safety of etanercept for this population was evaluated in a retrospective analysis of a previous study, which included 211 children (4-17 years) with psoriasis involving > or = 10% body surface area and Psoriasis Area and Severity Index (PASI) > or = 12. In this subanalysis, subjects aged 8-17 years received once-weekly subcutaneous etanercept 0.8 mg/kg (< or = 50 mg) or placebo in double-blind fashion for 12 weeks, followed by 24 weeks of open-label etanercept. Baseline demographics and disease characteristics were similar across treatment arms (etanercept n = 95, placebo n = 97). At week 12, 54.7% subjects receiving etanercept versus 11.3% receiving placebo achieved 75% or greater improvement in PASI (PASI 75) compared with baseline (p < 0.001). PASI 50, PASI 90, and static Physician Global Assessment of psoriasis followed a similar pattern (p < 0.001). Efficacy during the open-label phase was sustained through Week 36. Exposure-adjusted rates of adverse events for etanercept were similar or lower than those for placebo. No appreciable differences were noted in the efficacy and safety profiles between the subjects aged > or = 8 years in this analysis and those in the original study population aged 4-17 years. In conclusion, etanercept provided significant, sustained improvement in disease severity and was well tolerated in children > or = 8 years with severe plaque psoriasis. SN - 1167-1122 UR - https://www.unboundmedicine.com/medline/citation/20185386/Efficacy_and_safety_of_etanercept_in_children_and_adolescents_aged_>_or_=_8_years_with_severe_plaque_psoriasis_ L2 - http://www.john-libbey-eurotext.fr/medline.md?doi=10.1684/ejd.2010.0911 DB - PRIME DP - Unbound Medicine ER -