VANCOUVER – Field therapy for actinic keratoses using topical ingenol mebutate resulted in improved patient-reported outcomes in an observational study, Dr. Thomas L. Diepgen reported at the World Congress of Dermatology.
Topical ingenol mebutate won regulatory approval for the field treatment of actinic keratoses on the strength of four randomized, double-blind placebo-controlled clinical trials, but patients and their physicians need to know how the drug performs in clinical practice. The answer is, quite well, said Dr. Diepgen of the University of Heidelberg (Germany), who presented the results of the observational study emphasizing patient-reported outcomes in 826 patients whose actinic keratoses (AKs) were treated with ingenol mebutate (Picato) in 292 German dermatologists’ offices.
Bruce Jancin/Frontline Medical Media
Dr. Thomas L. Diepgen
Unlike in randomized clinical trials, where strict eligibility criteria often result in a skewed population of participants, this observational study provided a representative snapshot of German patients seeking AK therapy. Their mean age was 73 years, with a mean 6.2-year duration of AKs and a median baseline of 5 lesions. Eighty percent of patients had previously undergone other types of therapy for the AKs, and 34% of them had a history of nonmelanoma skin cancer.
Participants completed the Skindex-16 quality of life questionnaire at their baseline office visit, and again 8 weeks later. The Skindex-16 doesn’t ask disease-specific questions, but this 16-item questionnaire was employed in the earlier pivotal randomized trials (N. Engl. J. Med. 2012;366:1010-19), and investigators felt they should utilize the same instrument, said Dr. Diepgen.
Scores on the Skindex-16 improved significantly from a mean baseline of 24.3 out of a possible 96 points to 12.1 after 8 weeks.
Similarly, when patients were asked to rate their skin roughness, wrinkling, and/or blotchiness on a 0-3 scale, their mean scores fell from 1.46 at baseline to 0.69 at follow-up. Ninety-eight percent of patients reported no new skin anomalies such as hypopigmentation in the treatment area.
Session cochair Dr. Marc Bourcier of the University of Sherbrooke (Que.) observed that this study underscores that the timing of quality of life assessment makes an enormous difference. Had the assessment taken place at day 4, for example, when ingenol mebutate–induced skin irritation would have been prominent, the results would have been very different. Dr. Diepgen agreed, noting that he and his coinvestigators wanted to evaluate patients’ response to the long-lasting results of the treatment, rather than to the transient experience of the therapy.
The study was sponsored by Leo Pharma. Dr. Diepgen reported having received research grants and speakers fees, and/or serving on advisory boards for Leo and more than a dozen other pharmaceutical companies.