Crisaborole Ointment, 2%, for Treatment of Patients with Mild-to-Moderate Atopic Dermatitis: Systematic Literature Review and Network Meta-Analysis

Kyle Fahrbach, Jialu Tarpey, Evelien Bergrath*, Rachel Hughes, Howard H Z Thom, Maureen Neary, Amy Cha, Robert Gerber, Joseph Cappelleri

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

Abstract

Introduction: There is a need to compare efficacy and safety profiles of crisaborole ointment, 2%, versus other topical treatments across randomized clinical trials (RCTs). We performed this review/network meta-analysis to evaluate comparative efficacy and safety of crisaborole versus other topical pharmacological therapies for mild-to-moderate atopic dermatitis (AD) among patients aged ≥2 years.

Methods: Searches were conducted in MEDLINE, Embase, the Cochrane Collection Central Register of Clinical Trials, and the Database of Abstracts of Reviews of Effects using Ovid, to identify English language articles reporting RCTs of topical anti-inflammatory agents in patients aged ≥2 years with mild-to-moderate AD published between inception and March 10, 2020. This review used a prespecified protocol with eligibility criteria for population, interventions, comparisons, outcomes, and study design. Efficacy was evaluated using Investigator’s Static Global Assessment (ISGA) of clear (0) or almost clear (1) and expressed by hazard ratios with 95% credible intervals.

Results: Patients treated with crisaborole or tacrolimus ointment, 0.1% or 0.03%, versus vehicle alone were significantly more likely to achieve ISGA 0/1 at 28–42 days, with the greatest point estimate observed for the crisaborole comparison (hazard ratio [HR]: 2.07; 95% credible interval: 1.76 to −2.36; probability HR above 1 [p better]: 100.0%). Patients were also more likely to achieve ISGA 0/1 with crisaborole than with pimecrolimus cream, 1%, (HR: 1.62; 95% credible interval: 1.04 to 2.48; p better: 98.3%). While network meta-analysis for safety was not feasible due to data limitations, crisaborole pivotal studies (AD-301/AD-302), showed crisaborole was well tolerated.

Conclusions: Crisaborole was shown to be superior to vehicle and pimecrolimus and comparable to tacrolimus, 0.1% or 0.03%, with respect to ISGA 0/1 at 28–42 days in patients aged ≥2 years with mild-to-moderate AD. This evaluation of comparative efficacy of crisaborole further supports use of crisaborole as an effective therapeutic option in this population.
Original languageEnglish
JournalDermatology and Therapy
Publication statusAccepted/In press - 27 Apr 2020

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