Comparing atopic dermatitis treatments over time proves challenging

A meta-analysis of efficacy and safety findings for atopic dermatitis showed that comparing therapeutic options was difficult due to differing study methodologies and a lack of head-to-head trials.

“With the introduction of a new class of medications, topical phosphodiesterase inhibitors, and other topicals in development, it seemed reasonable to put together an analysis of prior studies on safety and efficacy of topical agents for AD published over the past 20 years,” Lawrence F. Eichenfield, MD, of the University of California, San Diego, told Healio.

The approval of the PDE4 inhibitor Eucrisa (crisaborole 2% ointment, Pfizer) to treat mild to moderate AD prompted the researchers to better understand efficacy and safety data not only for crisaborole, but for topical corticosteroids and topical calcineurin inhibitors, as well.

Eligible studies were published between Jan. 1, 1997, and April 30, 2018.

Findings for crisaborole demonstrated that the ointment is effective, with a manageable adverse event profile.

However, comparing crisaborole with other therapies yielded few conclusions because study designs, endpoints and methodologies differed for different drugs and across generations. Moreover, outcome definitions lacked precision, and safety reporting was inconsistent over time.

The researchers attributed much of this inconsistency to changes in guidelines for reporting trial results. Specifically, the adoption of the CONSORT statement and the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals adopted by the International Committee of Medical Journal Editors had a significant impact on reporting of the therapies under investigation.

As an example, the researchers reported that 12 of 28 studies failed to report total adverse events.

Despite the failure to draw clear conclusions, Eichenfield believes there is value to this research. “The paper serves as a good reference for the listing of studies of our presently approved nonsteroidal topical agents — calcineurin inhibitors and crisaborole — and as a resource to allow health care practitioners to see the extensive literature with which to judge safety and efficacy,” he said.

“It is interesting to see how the field has moved over the two decades and how much more standardized our clinical trials are now, aided by the Harmonising Outcome Measures for Eczema (HOME) group and other regional and international work,” Eichenfield said. – by Rob Volansky

Disclosure: Eichenfield reports he has been a consultant, investigator, data safety monitoring board member or speaker for Pfizer, Allergan, Anacor, Arcutis, Dermavant, Dermira, Eli Lilly, Galderma, Leo Pharma, Medimetriks, Novartis, Otsuka, Regeneron, Sanofi-Genzyme, OrthoDerm/Valeant and UCB.