Ingenolmebutat (1) – Picato®

• Clinical trials
  • The pharmaceutical manufacturer has identified studies for both ingenol mebutate gel and diclofenac-hyaluronic acid gel in which the intervention therapy is compared in each case with a vehicle gel that does not contain ingenol mebutate or diclofenac, respectively.

Treatment of single lesions (non-hyperkeratotic, non-hypertrophic actinic keratoses in adults)

• For adult patients with non-hyperkeratotic, non-hypertrophic actinic keratosis, the additional benefit of ingenol mebutate (Picato®) compared with the appropriate comparator therapy is not proven.
• An overall assessment of the results regarding mortality, morbidity, quality of life and side effects shows that ingenol mebutate offers no added benefit compared with the appropriate comparator therapy, 3% diclofenac-hyaluronic acid gel, in the treatment of non--hyperkeratotic, non-hypertrophic actinic keratoses do not provide any additional benefit.
• morbidity
  • With regard to the endpoint ‘complete healing rate’, the response rates in the vehicle arm of the ingenol mebutate studies range between 2.2% and 9.1%. In the hyaluronic acid-containing vehicle arm of the diclofenac-hyaluronic acid studies, the response rates range from 10.2% to 18.3%.
  • With regard to the endpoint ‘partial clearance rate’, the response rates in the vehicle arm of the ingenol mebutate studies range from 6.7% to 12.1%. In the hyaluronic acid-containing vehicle arm of the diclofenac-hyaluronic acid studies, response rates range from 20.4% to 44.1%.
  • As regards the results submitted by the pharmaceutical manufacturer for the endpoint ‘recurrence rate’ from two non-randomised comparative studies, these are descriptive presentations of the benefit of ingenol mebutate gel for this endpoint, based on a follow-up of patients from RCTs who achieved complete healing with ingenol mebutate.
  • Studies with diclofenac-hyaluronic acid gel relating to this endpoint were not included by the pharmaceutical manufacturer in the assessment.
• Overall assessment
  • In the overall assessment of the results regarding mortality, morbidity, quality of life and side effects, ingenol mebutate shows a 3% additional benefit compared with the appropriate comparator therapy, diclofenac-hyaluronic acid gel, in the treatment of non--hyperkeratotic, non-hypertrophic actinic keratoses do not provide any additional benefit.

Courtesy translation only, please refer to the German original.