AMNOG as a learning system: new study on ingenol mebutate in actinic keratosis shows added benefit

IQWiG

3 December 2018 - Advantage over diclofenac in complete clearance of visible lesions / unclear sustainability of treatment effect

In 2013, the German IQWiG examined in an early benefit assessment whether ingenol mebutate offers greater benefit than the appropriate comparator therapy (ACT) for patients with actinic keratosis. With the drug manufacturer presenting no suitable study data at that time, the conclusion was “added benefit not proven”. Due to new scientific findings, the manufacturer now applied for a new assessment.

In a randomized controlled trial, ingenol mebutate was now compared directly with the ACT diclofenac/hyaluronic acid. The study showed advantages in one outcome, i.e. complete clearance of visible skin lesions. It remains unclear whether this effect is permanent, however, as the study was ended after 120 days. Regarding other outcomes, there were no statistically significant effects, or no data were available. In particular, it remained unclear whether the treatment prevents squamous cell carcinoma, which can develop from actinic keratosis. Overall, this resulted in a hint of a non-quantifiable, at most considerable, added benefit of ingenol mebutate versus diclofenac/hyaluronic acid.

Read IQWiG press release

Michael Wonder

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Michael Wonder