Crisaborole Ointment, 2%, for Treatment of Patients with Mild-to-Moderate Atopic Dermatitis: Systematic Literature Revie
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ORIGINAL RESEARCH
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 Washington . Rachel Hughes . Howard Thom . Maureen P. Neary . Amy Cha . Robert Gerber . Joseph C. Cappelleri
Received: April 3, 2020 Ó The Author(s) 2020
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 the comparative efficacy and safety of crisaborole versus other topical pharmacologic therapies for mild-to-moderate atopic dermatitis (AD) among patients aged C 2 years.
Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12199766. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s13555020-00389-5) contains supplementary material, which is available to authorized users. K. Fahrbach J. Tarpey E. B. Washington (&) R. Hughes Evidence Synthesis, Modeling & Communication, Evidera, Waltham, MA, USA e-mail: [email protected] H. Thom Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK H. Thom Clifton Insight, Bristol, UK M. P. Neary Inflammation and Immunology, Pfizer Inc., Collegeville, PA, USA
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 C 2 years with mild-to-moderate AD published between inception and 10 March 2020. This review used a prespecified protocol with eligibility criteria for population, interventions, comparisons, outcomes, and study design. Efficacy was evaluated using the Investigator’s Static Global Assessment (ISGA) of clear (0) or almost clear (1) and expressed by hazard ratios (HR) 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 A. Cha Inflammation and Immunology, Pfizer Inc., New York, NY, USA R. Gerber Inflammation and Immunology, Pfizer Inc., Groton, CT, USA J. C. Cappelleri Global Biometrics and Data Management (Statistics), Pfizer Inc., Groton, USA
Dermatol Ther (Heidelb)
greatest point estimate observed for the crisaborole comparison (hazard ratio: 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 1.04–2.48; p better: 98.3%). While network meta-analysis for safety was not feasible because of data limitations, crisaborole pivotal studies (AD-301/AD-302) showed crisaborole was well
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