@article{e9d6ff33065a4b23b8334051868e264c,
title = "Direct and indirect effects of crisaborole ointment on quality of life in patients with atopic dermatitis: A mediation analysis",
abstract = "Crisaborole ointment is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate atopic dermatitis. Using pooled data from two phase 3 studies (NCT02118766/NCT02118792), mediation modeling determined the interrelationship among pruritus, quality of life (QoL), and treatment. Patients aged ≥ 2 years received crisaborole ointment, 2%, or vehicle twice daily for 28 days. QoL measures were Dermatology Life Quality Index (DLQI) (≥ 16 years) and Children{\textquoteright}s Dermatology Life Quality Index (CDLQI) (2–15 years). Pruritus was assessed by the Severity of Pruritus Scale (4-point scale from 0 to 3). The indirect effect of crisaborole on QoL mediated through its effect on pruritus was 51% (DLQI model, p < 0.05) and 72% (CDLQI model, p < 0.05). Direct effect (other effects) on QoL was 49% (DLQI model, p < 0.05) and 28% (CDLQI model, p > 0.05). Mediation modeling shows that crisaborole affects QoL mostly indirectly through pruritus severity reduction.",
keywords = "Atopic dermatitis, Crisaborole, Mediation, Pruritus, Quality of life",
author = "Simpson, {Eric L.} and Gil Yosipovitch and Bushmakin, {Andrew G.} and Cappelleri, {Joseph C.} and Thomas Luger and Sonja St{\"a}nder and Tom, {Wynnis L.} and Ports, {William C.} and Zielinski, {Michael A.} and Tallman, {Anna M.} and Huaming Tan and Gerber, {Robert A.}",
note = "Funding Information: Medical writing support under the guidance of the authors was provided by Robert J. Schoen, PharmD, and Corey Mandel, PhD, at ApotheCom, San Francisco, CA, USA, and was funded by Pfizer Inc., New York, NY, USA, in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461–4). This study was supported by Pfizer Inc. Conflicts of interest: ELS is a consultant for Eli Lilly, Gal-derma, Celgene, Leo Pharma, GlaxoSmithKline, AbbVie, Pfizer, Regeneron, and Menlo Therapeutics and a principal investigator for Leo Pharma, AbbVie, GlaxoSmithKline, Regeneron, Novar-tis, Tioga Pharmaceuticals, and Vanda Pharmaceuticals. GY is a consultant for OPKO Health, Castle Creek Pharmaceuticals; a member of scientific advisory boards for Menlo Therapeutics, Trevi Therapeutics, Sanofi, Galderma, Eli Lilly, Novartis, and Sienna Biopharmaceuticals; and a principal investigator for Pfizer, Allergan, the Leo Foundation, Sun Pharmaceutical Industries, Vanda Pharmaceuticals, and Menlo Therapeutics. TL is an investigator for AbbVie, Celgene, Eli Lilly, Novartis, Pfizer, Sandoz, Menlo Therapeutics, and Leo Pharma; is a member of scientific advisory boards for AbbVie, Argenx, Celgene, Ceres Pharma, Galderma, Eli Lilly, Jansen-Cilag, La Roche-Posay, Mylan/Meda AB, Novartis, Pfizer, Sandoz, Sanofi-Aventis, Symrise, Menlo Therapeutics, Leo Pharma, Pierre Fabre, and Piqur Therapeutics; and has received funding from AbbVie, Celgene, Jansen-Cilag, Mylan/Meda AB, Merck Sharp & Dohme, Novartis, Pfizer, and Wolff Laboratories. SS is a principal investigator for Dermasence, Menlo Therapeutics, Trevi Therapeutics, Galderma, and Novartis; a member of scientific advisory boards for Beiersdorf, Celgene, Galderma, Kiniksa Pharmaceuticals, Menlo Therapeutics, NeRRe Therapeutics, Sienna Biopharmaceuticals, and Trevi Therapeutics; and a consultant for Novartis. WLT is a principal investigator for Pfizer, Regeneron, Medimetriks Pharmaceuticals, Incyte Corporation, Celgene, Janssen Pharmaceuticals, Promius Pharma, and Dermira. RAG, JCC, HT, WCP, and AB are employees and stockholders of Pfizer Inc. AMT is a former employee and stockholder of Pfizer Inc. Publisher Copyright: {\textcopyright} 2019 Acta Dermato-Venereologica.",
year = "2019",
month = jul,
doi = "10.2340/00015555-3181",
language = "English (US)",
volume = "99",
pages = "756--761",
journal = "Acta dermato-venereologica",
issn = "0001-5555",
publisher = "Society for the Publication of Acta Dermato-Venereologica",
number = "9",
}