Clinical efficacy and safety of topical difamilast in the treatment of patients with atopic dermatitis: a systematic review and meta-analysis of randomized controlled trials

ABSTRACT

Objective

To investigate the clinical efficacy and safety of topical difamilast in mild-to-moderate atopic dermatitis (AD).

Methods

Only randomized controlled trials (RCTs) that compared topical difamilast with vehicle treatment for patients with AD were included. PubMed, Web of Science, Ovid Medline, Cochrane Library, ClinicalTrials.gov and JapicCTI were searched to 10 April 2022.

Results

Five studies enrolling a total of 1009 patients with mild-to-moderate AD were identified. Compared with the topical vehicle, topical difamilast was associated with a significantly higher success rate according to the Investigator’s Global Assessment score at week 4 (relative risk, 2.82; 95% confidence interval [CI]: 2.11–3.77). Compared with the vehicle, difamilast was associated with a significant decrease in day 28 eczema area and severity index scores (mean difference [MD], −4.10; 95% CI: −5.32 to −2.87), verbal rating scale scores (MD, −0.51; 95% CI: −0.71 to −0.32), visual analog scale scores (MD, −12.15; 95% CI: −19.70 to −4.61), patient-oriented eczema measure values (MD, −3.99; 95% CI: −4.91 to −3.07), and total affected body surface area (MD, −6.48; 95% CI: −8.09 to −4.87). No difference in treatment-related adverse events was identified.

Conclusions

This meta-analysis suggests that topical difamilast is an effective and safe treatment for mild-to-moderate AD.

KEYWORDS:

• Difamilast
• atopic dermatitis
• phosphodiesterase 4 inhibitors
• vehicle
• ointment

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

A reviewer on this manuscript has disclosed being on the advisory boards for AbbVie, Boehringer Mannheim, Janssen Cilag, Pfizer, MSD, Mundipharma, Novartis, Amgen, Leo, Sanofi, and UCB; being on the speaker boards for AbbVie, Boehringer Mannheim, Celgene, Janssen Cilag, Leo, MSD, Novartis, and Pfizer; and clinical studies for AbbVie, Amgen, Boehringer Mannheim, Celgene, Galderma, GSK, Janssen Cilag, Leo, Novartis, Pfizer, Regeneron, and Sanofi. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Author contributions

Conception: L-C Lu, C-M Chao, C-C Lai; study design: L-C Lu, C-M Chao, S-P Chang, C-C Lai; analysis and interpretation: S-H Lan, S-P Chang, L-C Lu; drafted or written: C-M Chao, C-C Lai; substantially revised or critically review: C-C Lai. All authors have agreed on the journal to which the article will be submitted and reviewed and agreed on all versions of the article before submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage. In addition, all authors agree to take responsibility and be accountable for the contents of the article and to share responsibility to resolve any questions raised about the accuracy or integrity of the published work.

Data availability statement

All data were obtained from the original study.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/17512433.2022.2134114

Additional information

Funding

This paper was not funded.