Ingenol mebutate gel for actinic keratosis: the link between quality of life, treatment satisfaction, and clinical outcomes

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Ingenol mebutate gel for actinic keratosis: the link between quality of life, treatment satisfaction, and clinical outcomes. / Augustin, Matthias; Tu, John H; Knudsen, Kim Mark; Erntoft, Sandra; Larsson, Thomas; Hanke, C William.

in: J AM ACAD DERMATOL, Jahrgang 72, Nr. 5, 05.2015, S. 816-821.

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@article{4a5b9b3d6a554e6d97fb963d4d0980df,
title = "Ingenol mebutate gel for actinic keratosis: the link between quality of life, treatment satisfaction, and clinical outcomes",
abstract = "BACKGROUND: Actinic keratosis therapy can elicit unsightly and painful local skin responses; assessment of treatment satisfaction and health-related quality of life (QoL) is important. Ingenol mebutate gel is a novel topical field therapy for actinic keratosis.OBJECTIVE: Post-hoc analyses were performed based on patient-reported outcomes from phase-III trials (n = 1005) to assess the effects of ingenol mebutate on QoL and the relationship between both QoL and treatment satisfaction, and degree of lesion clearance.METHODS: Patients received ingenol mebutate or vehicle for self-application to a 25-cm(2) contiguous area: 0.015% once daily for 3 consecutive days (face/scalp) or 0.05% once daily for 2 consecutive days (trunk/extremities). QoL (Skindex-16) and Treatment Satisfaction Questionnaire for Medication data were recorded.RESULTS: Significant, positive associations between Treatment Satisfaction Questionnaire for Medication score and degree of clearance were identified for patients in the face/scalp (effectiveness P < .0001 and global satisfaction P = .0002) and trunk/extremities (P < .0001 and P = .0014, respectively) groups. There was a significant association between Skindex-16 score and clearance for patients in the face/scalp group for change in symptoms (P = .0218), emotions (P = .0002), and overall Skindex-16 score (P = .0006) from baseline.LIMITATIONS: Clinical trial population findings may not be generalizable to clinical practice.CONCLUSION: Ingenol mebutate significantly improved patients' QoL and treatment satisfaction. Improvements were associated with higher degrees of actinic keratosis lesion clearance.",
keywords = "Administration, Topical, Diterpenes, Drug Administration Schedule, Gels, Humans, Keratosis, Actinic, Patient Satisfaction, Pharmaceutical Vehicles, Quality of Life, Self Administration, Surveys and Questionnaires, Treatment Outcome",
author = "Matthias Augustin and Tu, {John H} and Knudsen, {Kim Mark} and Sandra Erntoft and Thomas Larsson and Hanke, {C William}",
note = "Copyright {\textcopyright} 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.",
year = "2015",
month = may,
doi = "10.1016/j.jaad.2015.01.036",
language = "English",
volume = "72",
pages = "816--821",
journal = "J AM ACAD DERMATOL",
issn = "0190-9622",
publisher = "Mosby Inc.",
number = "5",

}

RIS

TY - JOUR

T1 - Ingenol mebutate gel for actinic keratosis: the link between quality of life, treatment satisfaction, and clinical outcomes

AU - Augustin, Matthias

AU - Tu, John H

AU - Knudsen, Kim Mark

AU - Erntoft, Sandra

AU - Larsson, Thomas

AU - Hanke, C William

N1 - Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

PY - 2015/5

Y1 - 2015/5

N2 - BACKGROUND: Actinic keratosis therapy can elicit unsightly and painful local skin responses; assessment of treatment satisfaction and health-related quality of life (QoL) is important. Ingenol mebutate gel is a novel topical field therapy for actinic keratosis.OBJECTIVE: Post-hoc analyses were performed based on patient-reported outcomes from phase-III trials (n = 1005) to assess the effects of ingenol mebutate on QoL and the relationship between both QoL and treatment satisfaction, and degree of lesion clearance.METHODS: Patients received ingenol mebutate or vehicle for self-application to a 25-cm(2) contiguous area: 0.015% once daily for 3 consecutive days (face/scalp) or 0.05% once daily for 2 consecutive days (trunk/extremities). QoL (Skindex-16) and Treatment Satisfaction Questionnaire for Medication data were recorded.RESULTS: Significant, positive associations between Treatment Satisfaction Questionnaire for Medication score and degree of clearance were identified for patients in the face/scalp (effectiveness P < .0001 and global satisfaction P = .0002) and trunk/extremities (P < .0001 and P = .0014, respectively) groups. There was a significant association between Skindex-16 score and clearance for patients in the face/scalp group for change in symptoms (P = .0218), emotions (P = .0002), and overall Skindex-16 score (P = .0006) from baseline.LIMITATIONS: Clinical trial population findings may not be generalizable to clinical practice.CONCLUSION: Ingenol mebutate significantly improved patients' QoL and treatment satisfaction. Improvements were associated with higher degrees of actinic keratosis lesion clearance.

AB - BACKGROUND: Actinic keratosis therapy can elicit unsightly and painful local skin responses; assessment of treatment satisfaction and health-related quality of life (QoL) is important. Ingenol mebutate gel is a novel topical field therapy for actinic keratosis.OBJECTIVE: Post-hoc analyses were performed based on patient-reported outcomes from phase-III trials (n = 1005) to assess the effects of ingenol mebutate on QoL and the relationship between both QoL and treatment satisfaction, and degree of lesion clearance.METHODS: Patients received ingenol mebutate or vehicle for self-application to a 25-cm(2) contiguous area: 0.015% once daily for 3 consecutive days (face/scalp) or 0.05% once daily for 2 consecutive days (trunk/extremities). QoL (Skindex-16) and Treatment Satisfaction Questionnaire for Medication data were recorded.RESULTS: Significant, positive associations between Treatment Satisfaction Questionnaire for Medication score and degree of clearance were identified for patients in the face/scalp (effectiveness P < .0001 and global satisfaction P = .0002) and trunk/extremities (P < .0001 and P = .0014, respectively) groups. There was a significant association between Skindex-16 score and clearance for patients in the face/scalp group for change in symptoms (P = .0218), emotions (P = .0002), and overall Skindex-16 score (P = .0006) from baseline.LIMITATIONS: Clinical trial population findings may not be generalizable to clinical practice.CONCLUSION: Ingenol mebutate significantly improved patients' QoL and treatment satisfaction. Improvements were associated with higher degrees of actinic keratosis lesion clearance.

KW - Administration, Topical

KW - Diterpenes

KW - Drug Administration Schedule

KW - Gels

KW - Humans

KW - Keratosis, Actinic

KW - Patient Satisfaction

KW - Pharmaceutical Vehicles

KW - Quality of Life

KW - Self Administration

KW - Surveys and Questionnaires

KW - Treatment Outcome

U2 - 10.1016/j.jaad.2015.01.036

DO - 10.1016/j.jaad.2015.01.036

M3 - SCORING: Journal article

C2 - 25770879

VL - 72

SP - 816

EP - 821

JO - J AM ACAD DERMATOL

JF - J AM ACAD DERMATOL

SN - 0190-9622

IS - 5

ER -