A pan-European register-based observational study of abrocitinib and conventional systemic therapies in moderate and severe atopic dermatitis: the DREAM TO TREAT AD study protocol
Year: 2025
Type: article
Study design: Study Protocol
Abstract: Background: Atopic dermatitis (AD) is a common chronic inflammatory skin condition. Currently, there is a lack of real-world evidence regarding the effectiveness of systemic therapies for moderate-to-severe AD. Abrocitinib is a novel Janus kinase 1 selective inhibitor licensed for AD in adults and adolescents requiring systemic treatment. The DREAM TO TREAT AD (D2T AD) study was set up to collect real-world data on abrocitinib and conventional systemic treatment use in moderate-to-severe AD. It aims to describe treatment patterns and effectiveness within a 3-year follow-up period in five registers: Ireland [Atopic Eczema Systemic Therapy Register (A-STAR) Ireland], Denmark (SCRATCH), Germany (TREATgermany), the Netherlands and Belgium (TREAT NL/BE), and the UK (A-STAR UK). Methods: The study protocol and methodology were developed collaboratively by academics of the participating registers with the study funder. The study follow-up timepoints and outcomes are based on an international Delphi exercise previously run by the TREAT Registry Taskforce. All five registers collect data in several domains, including patients' characteristics and treatment outcomes in patients receiving systemic treatment. Assignment to treatment was decided by the treating clinician. Data collected by the registers will be transformed into harmonized datasets and then to analytical datasets (ADS) to address research questions. Study objectives include describing patient baseline characteristics, in addition to clinician- (Eczema Area and Severity Index) and patient-reported outcomes [Patient-Reported Eczema Measure (POEM), Children's/Dermatology Life Quality Index (C/DLQI), Peak Pruritus Numeric Rate Scale (PP-NRS)] at baseline and follow-up, as well as treatment patterns while on abrocitinib and conventional systemic treatments. The ADS will be analysed using the novel DataSHIELD solution that enables centralized statistical analysis on decentralized data (i.e. without data leaving the register of origin). The DataSHIELD solution includes central analytic hubs (CAHs) and local data nodes (LDNs). CAH can remotely interrogate LDNs via an internet connection using analytical commands. Each LDN produces local statistical results that are sent back to the CAH, which can then combine the results from all LNDs without seeing any patient-level data. Discussion: D2T AD undertakes a novel federated data analysis approach across five registers in observational dermatology research and will provide crucial information on AD treatment outcomes for clinical decision-making, in addition to proving the feasibility of this type of scientific collaboration. Protocol registration: EMA RWD Catalogue (EU PAS no.: 108468; study ID: 199009; https://catalogues.ema.europa.eu/node/3894/administrative-details).
Source: Skin Health and Disease
Authors: Elizaveta Gribaleva, Niels Steen Krogh, David Prieto-Merino, Bolaji Coker, Abaigeal Jackson, Ahmet Akkoc, Thomas Birkner, Erwin Bruninx, Con Hennessy, Kaitlyn Chan, Lara Cutlar, Byron Farrell, Godfrey Fletcher, Louise Gerbens, Anne Grete Frostrup, Dan Henrohn, Ariënna Hyseni, Alan D Irvine, Rayka Malek, Caitriona McCarthy, Ida Vittrup, Wouter Ouwerkerk, Rowena Randall, Phyllis I Spuls, Simon Francis Thomsen, Dmitri Wall, Stephan Weidinger, Thomas Werfel, Jochen Schmitt, Carsten Flohr
Institutions: King's College London, Universidad de Alcalá, Guy's and St Thomas' NHS Foundation Trust, Pfizer (Ireland), University Hospital Carl Gustav Carus, Zentrum für Evidenzbasierte Gesundheitsversorgung, Technische Universität Dresden, Pfizer (Belgium), University College Dublin, St Thomas' Hospital, Brown University, Amsterdam Public Health, Amsterdam University Medical Centers, University of Amsterdam, Uppsala University, Trinity College Dublin, Copenhagen University Hospital, Pfizer (United Kingdom), University Hospital Schleswig-Holstein, Medizinische Hochschule Hannover
Language: English
Subfield: Dermatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,597
Funder: Pfizer
OpenAlex ID: W4409664110