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Observational Study
. 2020 Nov 27;10(11):e039928.
doi: 10.1136/bmjopen-2020-039928.

International observational atopic dermatitis cohort to follow natural history and treatment course: TARGET-DERM AD study design and rationale

Katrina Abuabara  1 , Jonathan I Silverberg  2 , Eric L Simpson  3 , Amy S Paller  4 , Lawrence F Eichenfield  5 , Robert Bissonnette  6 , James Krueger  7 , John E Harris  8 , Laura Dalfonso  9 , Stephanie E Watkins  10 , Julie M Crawford  10 , D Thaçi  11 , Emma Guttman-Yassky  12
Affiliations
Observational Study

International observational atopic dermatitis cohort to follow natural history and treatment course: TARGET-DERM AD study design and rationale

Katrina Abuabara et al. BMJ Open. .

Abstract

Introduction: As new topical and systemic treatments become available for atopic dermatitis (AD), there is a need to understand how treatments are being used in routine clinical practice, their comparative effectiveness and their long-term safety in diverse clinical settings.

Methods and analysis: The TARGET-DERM AD cohort is a longitudinal, observational study of patients with AD of all ages, designed to provide practical information on long-term effectiveness and safety unobtainable in traditional registration trials. Patients with physician-diagnosed AD receiving prescription treatment (topical or systemic) will be enrolled at academic and community clinical centres. Up to 3 years of retrospective medical records, 5 years of prospective medical records, and optional biological samples and patient-reported outcomes will be collected. The primary aims include characterisation of AD treatment regimens, evaluation of response to therapy, and description of adverse events.

Ethics and dissemination: TARGET-DERM has been approved by a central IRB (Copernicus Group IRB, 5000 Centregreen Way Suite 200, Cary, North Carolina 27513) as well as local and institutional IRBs. No additional Ethics Committee reviews. Results will be reviewed by a publications committee and submitted to peer-reviewed journals.

Trial registration number: NCT03661866, pre-results.

Keywords: eczema; medical history; statistics & research methods; therapeutics.

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Conflict of interest statement

Competing interests: KA: receives compensation for consulting services from TARGET PharmaSolutions; no other competing interests. JIS: AbbVie, Anaptysbio, Arena, Asana, Boehringer-Ingelheim, Dermira, Dermavant, DS Biopharma, Eli Lilly, Galderma, GlaxoSmithKline, Glenmark, Incyte, Kiniksa, LEO Pharma, Luna, Menlo, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi – consultant or advisory board member; Regeneron Pharmaceuticals, Sanofi – speaker. ELS: grants and personal fees from AbbVie, grants and personal fees from Eli Lilly, grants from Galderma, grants from Kyowa Hakko Kirin, grants and personal fees from Leo Pharmaceutical, grants from Merck, grants and personal fees from Pfizer, grants and personal fees from Regeneron, personal fees from Sanofi, personal fees from Dermira, grants from Galderma, grants and personal fees from MedImmune, grants from Novartis, grants from Tioga, grants from Celgene, personal fees from Boehringer-Ingelheim, personal fees from Dermavant, personal fees from Forte Bio, personal fees from Incyte, personal fees from Menlo Therapeutics, personal fees from Ortho Dermatologics, personal fees from Pierre Fabre Dermo Cosmetique, personal fees from Valeant. ASP: investigator for AbbVie, Anaptysbio, Celgene, Eli Lilly, Galderma, Incyte, Leo, Janssen, Novartis, and Regeneron; consultant with honorarium for Almirall, Amgen, Asana, Boehringer-Ingelheim, Castle Creek, Celgene, Dermavant, Dermira, Eli Lilly, Exicure, Forte, Galderma, Lenus, Leo, MEDA Corp, Meiji Seika, Novan, Novartis, Pfizer, Regeneron, Sanofi-Genzyme, and Sol Gel. LE: Consultant/Speaker/Advisory Board: Almirall, Dermavant, Dermira, DS Biopharma, Forte, Galderma, Incyte, LEO, Lilly, L’Oreal, Matrisys, Otsuka, Novartis, Ortho Dermatologics/Valeant, Pfizer/Anacor, Regeneron, Sanofi-Genzyme. Investigator: Abvie, LEO, Regeneron, Sanofi-Genzyme. DSM: Asana, Ichnos/Glenmark. RB: Advisory Board Member, Consultant, Speaker, Investigator for and/or receives honoraria or grant from AbbVie, AntibioTx, Arcutis, Arena Pharma, Asana BioSciences, Bellus Health, Boehringer-Ingelheim, Dermavant, Eli Lilly, EMD Serono, Galderma, Incyte, Kiniksa, Kyowa Kirin, Neokera, LEO Pharma, Novan, Pfizer, Ralexar, RAPT, Regeneron, Sanofi Genzyme and Sienna. Employee and shareholder of Innovaderm Research. JK: Personal fees from Novartis, Pfizer, Amgen, Lilly, Boehringer, BMS, Biogenldec, Janssen, AbbVie, Leo Pharma, ESCALIER, Valeant, Allergan, Aurigene, Sienna, UCB, Allergan, Asana, Celgene, Nimbus, Menlo, Aristea, Sanofi, Sun Pharma, Almirall, Arena, Ventyx, Aclaris, Galapagos. Grants paid to Institution from Novartis, Pfizer, Amgen, Lilly, Boehringer, Innovaderm, BMS, Janssen, AbbVie, Parexel, Leo Pharma, Vitae, Akros, Regeneron, Allergan, Novan, Biogen MA, Sienna, UCB, Celgene, Botanix, Incyte, Avillion, Exicure. JH: consultant for Pfizer, Genzyme/Sanofi, Aclaris Therapeutics, Incyte, Theos Medicines, Sun Pharmaceuticals, LEO Pharma, Villaris Therapeutics, Dermavant, Temprian, AbbVie, Inc., Janssen, TeVido BioDevices, EMD Serono, Almirall, Boston Pharma, Sonoma Biotherapeutics, Inc., Methuselah Health, Twi Biotech, Pandion, Cogen Therapeutics, Inc., Admirx and BridgeBio. Investigator for Pfizer, Genzyme/Sanofi, Aclaris Therapeutics, Incyte, Theos Medicines, Sun Pharmaceuticals, LEO Pharma, Villaris Therapeutics, Dermavant, AbbVie, Inc., TeVido BioDevices, EMD Serono and Pandion. Equity in TeVido Biodevices, Rheos, Villaris Therapeutics, Inc. Scientific Founder of Villaris Therapeutics, Inc. LD: employee at TARGET PharmaSolutions. SEW: employee at TARGET PharmaSolutions. JMC: employee at TARGET PharmaSolutions. DT: is a lecturer and/or consultant for AbbVie, Almirall, Amgen, Asana Biosciences, Biogen Idec, BIOCAD, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, DS-Biopharma, GlaxoSmithKline, Janssen-Cilag, Kyowa Kirin, Leo Pharma, Eli Lilly, Novartis, Regeneron, Sandoz, Sanofi-Aventis and UCB, and received grants from AbbVie and Novartis (paid to institution). EGY: employee of Mount Sinai and has received research funds (grants paid to the institution) from Abbvie, Almirall, Amgen, AnaptysBio, Asana Biosciences, Boerhinger-Ingelhiem, Celgene, Dermavant, DS Biopharma, Eli Lilly, Galderma, Ichnos Sciences, Innovaderm, Janssen, Kiniska, Kyowa Kirin, Leo Pharma, Novan, Pfizer, Ralexar, Regeneron, Sienna Biopharma, UCB, and Union Therapeutics. EGY is also a consultant for Abbvie, Almirall, Amgen, Arena Pharmaceuticals, Asana Biosciences, AstraZeneca Biopharmaceuticals, Boerhinger-Ingelhiem, Cara Therapeutics, Celgene, Concert, DBV, Dermira, DS Biopharma, Eli Lilly, EMD Serono, Escalier, Galderma, Ichnos Sciences, Kyowa Kirin, Leo Pharma, Mitsubishi Tanabe, Pandion Therapeutics, Pfizer, RAPT Therapeutics, Regeneron, Sanofi, Sienna Biopharma, and Union Therapeutics.

Figures

Figure 1
Figure 1
TARGET-DERM has active community (24) and academic (10) sites across the USA.
See this image and copyright information in PMC

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