Defining disease severity in atopic dermatitis and psoriasis for the application to biomarker research: an interdisciplinary perspective.

More severe atopic dermatitis and psoriasis are associated with a higher cumulative impact on quality of life, multimorbidity and healthcare costs. Proactive, early intervention in those most at risk of severe disease may reduce this cumulative burden and modify the disease trajectory to limit progression. The lack of reliable biomarkers for this at-risk group represents a barrier to such a paradigm shift in practice. To expedite discovery and validation, the BIOMarkers in Atopic Dermatitis and Psoriasis (BIOMAP) consortium (a large-scale European, interdisciplinary research initiative) has curated clinical and molecular data across diverse study designs and sources including cross-sectional and cohort studies (small-scale studies through to large multicentre registries), clinical trials, electronic health records and large-scale population-based biobanks. We map all dataset disease severity instruments and measures to three key domains (symptoms, inflammatory activity and disease course), and describe important codependencies and relationships across variables and domains. We prioritize definitions for more severe disease with reference to international consensus, reference standards and/or expert opinion. Key factors to consider when analysing datasets across these diverse study types include explicit early consideration of biomarker purpose and clinical context, candidate biomarkers associated with disease severity at a particular point in time and over time and how they are related, taking the stage of biomarker development into account when selecting disease severity measures for analyses, and validating biomarker associations with disease severity outcomes using both physician- and patient-reported measures and across domains. The outputs from this exercise will ensure coherence and focus across the BIOMAP consortium so that mechanistic insights and biomarkers are clinically relevant, patient-centric and more generalizable to current and future research efforts.
Competing Interests: Conflicts of interest S.M.L. has received funding from a Wellcome Trust Senior Research Fellowship in Clinical Science (205039/Z/16/Z). A.E. has received research funding from Almirall, Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb, AbbVie, Janssen Pharmaceuticals, Boehringer Ingelheim, the Danish National Psoriasis Foundation, the Simon Spies Foundation and the Kgl Hofbundtmager Aage Bang Foundation, and honoraria as consultant and/or speaker from Amgen, AbbVie, Almirall, LEO Pharma, Zuellig Pharma Ltd., Galapagos NV, Sun Pharmaceuticals, Samsung Bioepis Co., Ltd., Pfizer, Eli Lilly and Company, Novartis, Union Therapeutics, Galderma, Dermavant, UCB, Mylan, Bristol Myers Squibb, McNeil Consumer Healthcare, Horizon Therapeutics, Boehringer Ingelheim and Janssen Pharmaceuticals. E.d.J. has received research grants for the department of dermatology of Radboud University Medical Centre Nijmegen from AbbVie, BMS, Janssen Pharmaceutica, LEO Pharma, Lilly, Novartis, UCB, ZonMw, KCE, NWO, the National Psoriasis Foundation USA and Horizon 2020 European funding (Immuniverse). She has acted as consultant and/or paid speaker for and/or participated in research sponsored by companies that manufacture drugs used for the treatment of psoriasis or eczema including AbbVie, Amgen, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Galapagos, Janssen Pharmaceutica, Lilly, Novartis, LEO Pharma, Sanofi and UCB. All funding is not personal but goes to the Institution Radboud University Medical Center Nijmegen. M.A.M.-H. has carried out consultancy for Sanofi, Pfizer and LEO Pharma and is one of the main investigators of the TREAT NL registry. A.B. reports multiple grants from H2020 and HEurope with various industry partners. L.S. reports grants from Novartis, Bristol Myers Squibb, AbbVie, Janssen Pharmaceuticals, Sanofi, Almirall, the Danish National Psoriasis Foundation and the LEO Foundation and honoraria as consultant and/or speaker for AbbVie, Eli Lilly, Novartis, Pfizer, LEO Pharma, Janssen, UCB, Almirall, Bristol Myers Squibb, Galderma and Sanofi. S.K.M. has received research funding (but no personal payments) from Wellcome Trust, British Skin Foundation, European Lead Factory EU/IMI (multiple pharma participants), Charles Wolfson Charitable Trust, Rosetrees Trust, Stoneygate Trust, anonymous donations from people with eczema, Pfizer, AbbVie, Sosei Heptares, Janssen and Unilever. J.N.B. has received honoraria and/or research grants from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Janssen, LEO Pharma, Lilly, Novartis, Samsung and Sun Pharma. C.H.S. reports grants from an MRC-funded stratified medicine consortium with multiple industry partners, grants from IMI (Horizon 2020-funded) European consortium with multiple industry partners, and other funding from AbbVie, Novartis, Pfizer, Sanofi, Boehringer Ingelheim and SOBI, outside the submitted work, and is Chair of UK guidelines on biologic therapy in psoriasis.
(© The Author(s) 2024. Published by Oxford University Press on behalf of British Association of Dermatologists.)