A new topical medication, Eucrisa, for treating eczema has recently been approved by the FDA. With keen interest I read every word of the backup study and publication in the Journal of the American Academy of Dermatology concerning then named Opa-15406, a novel topical non-steroidal PDE4 inhibitor. The study included patients who had just recently stopped steroid usage but for only a short period of time. This makes me question the results of the study and the supposed efficacy of the medication.
In over 40 years of being the principal investigator in scores of drug studies I never seen nor participated in any study where both active and placebo groups ‘dropped out’ without any ready explanation. In the fine print of this study 25% of all subjects vanished. In any well-groomed, appropriately protocol proven study less than 2 or 3 patients drop. Why was there a huge percentage dropping out of this study? I strongly believe they were all steroid addicted patients, not true eczema and were in flares of their addiction.
This paper had charts, bar graphs, tables and numerous statistics that I found both confusing and totally misleading. Basically, in dissecting the data I found that there were only minor differences between drug and placebo. All the data cited was subjective, namely itching and ‘how are you feeling?’ There was no objective information. This is the same kind of ‘dirty data’ that I cited in my comments of the last 2 weeks concerning Dupilumab. False hope again.
Large amounts are spent to bring new drugs to this large group of misdiagnosed and mistreated ‘eczema’ patients. They are all steroid addicted and do not need a new high priced spread that will not work.