Ingenol mebutate gel for actinic keratosis: The link between quality of life, treatment satisfaction, and clinical outcomes - 17/04/15
, John H. Tu, MD b, c, Kim Mark Knudsen, PhD d, Sandra Erntoft, PhD d, Thomas Larsson, Dr Med Sci d, C. William Hanke, MD eAbstract |
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-cm2 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.
Le texte complet de cet article est disponible en PDF.Key words : actinic keratosis, clearance, ingenol mebutate, quality of life, Skindex-16, Treatment Satisfaction Questionnaire for Medication
Abbreviations used : AK, QoL, TSQM
Plan
| These studies (PEP005-014; PEP005-016; PEP005-025; PEP005-028) were funded by Peplin Operations Pty Ltd (subsequently acquired by LEO Pharma A/S). |
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| Disclosure: Dr Augustin has served as a consultant and investigator for LEO Pharma A/S and Almirall. Dr Tu reports industry relationships with TOLMAR, Photocure, Graceway Pharmaceuticals, Apotex, Nycomed Pharma, and Teva Pharmaceutical Industries. Drs Knudsen, Erntoft, and Larsson are employees of LEO Pharma A/S. Dr Hanke reports industry relationships with Allergan, Dermik, Educational Testing and Assessment Systems, Eli Lilly, Elsevier, Galderma, Informa, Kythera, LEO Pharma A/S, Merz Pharma, Orlando Dermatology Aesthetic and Clinical, Sanova Dermatology, and Springer. |
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Some of these data have been presented previously:
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Vol 72 - N° 5
P. 816-821 - mai 2015 Retour au numéro
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