TY - JOUR

T1 - Requirements and expectations of high-quality biomarkers for atopic dermatitis and psoriasis in 2021—a two-round Delphi survey among international experts

AU - Ziehfreund, S.

AU - Tizek, L.

AU - Hangel, N.

AU - Fritzsche, M. C.

AU - Weidinger, S.

AU - Smith, C.

AU - Bryce, P. J.

AU - Greco, D.

AU - van den Bogaard, E. H.

AU - Flohr, C.

AU - Rastrick, J.

AU - Eyerich, S.

AU - Buyx, A.

AU - Conrad, C.

AU - Eyerich, K.

AU - Zink, A.

N1 - Funding Information: This study has been supported by BIOMAP (Biomarkers in Atopic Dermatitis and Psoriasis, http://www.biomap‐imi.eu/ ), a project funded by the Innovative Medicines Initiative 2 Joint Undertaking under Grant Agreement No. 821511 and in‐kind contributions of participating pharma companies. The Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Funding Information: S.Z. No conflict of interest directly related to the work. L.T. No conflict of interest directly related to the work. N.H. No conflict of interest directly related to the work. S.W. Principal investigator of the TREATGermany AD registry (NCT03057860) and coordinator of the European Union Horizon 2020—funded BIOMAP Consortium ( http://www.biomap‐imi.eu/ ). He has received institutional research grants from Sanofi Deutschland GmbH, Leo Pharma and La Roche Posay and has performed consultancies and or lectures for Abbvie, Almirall, Eli Lilly, LEO Pharma, Galderma, GSK, Pfizer, Sanofi‐Genzyme and Regeneron. C.H. Smith has received departmental research funding from AbbVie, Novartis, Pfizer and Sanofi and has served as an investigator on Medical Research Council—and Horizon 2020—funded consortia with industry partners (see psort.org.uk and biomap—imi.eu); SOBI provided the drug for a National Institute for Health Research—funded trial in pustular psoriasis. P.J.B. is a paid employee of Sanofi. D.G. No conflict of interest directly related to the work. E.v.d.B. No conflict of interest directly related to the work. C.F. Chief investigator of the UK National Institute for Health Research—funded TREAT (ISRCTN15837754) and SOFTER ( ClinicalTrials.gov : NCT03270566) trials and the UK‐Irish Atopic Eczema Systemic Therapy Register (A‐STAR; ISRCTN11210918)—and is a principal investigator in the European Union Horizon 2020—funded BIOMAP Consortium ( http://www.biomap‐imi.eu/ ). He is also CI of the EU Joint Programme Initiative—funded TRANS‐FOODS consortium. His department has also received funding from Sanofi‐Genzyme. J.R. No conflict of interest directly related to the work. S.E. No conflict of interest directly related to the work. A.B. No conflict of interest directly related to the work. C.C. Consultant and/or principal investigator in clinical trials for AbbVie, Actelion, Amgen, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, Incyte, Janssen‐Cilag, LEO Pharma, MSD, Novartis, Pfizer, Samsung, Sanofi‐Genzyme and UCB Pharma. No conflict of interest directly related to the work. K.E. receives speakers fees and/or honoraria from Abbvie, Almirall, BMS, Lilly, Leo, Janssen, Novartis, Pfizer, Galderma, UCB and Sanofi. No conflict of interest directly related to the work. A.Z. has been an advisor and/or received speaker's honoraria and/or received grants and/or participated in clinical trials of the following companies: AbbVie, Almirall, Amgen, Beiersdorf Dermo Medical, Bencard Allergie, BMS, Celgene, Eli Lilly, GSK, Janssen‐Cilag, Leo Pharma, Miltenyi Biotec, Novartis, Pfizer, Sanofi‐Aventis, Takeda Pharma and UCB Pharma.

PY - 2022/8/18

Y1 - 2022/8/18

N2 - Background: Chronic inflammatory skin diseases such as atopic dermatitis (AD) and psoriasis (PSO) present major challenges in health care. Thus, biomarkers to identify disease trajectories and response to treatments to improve the lives of affected individuals warrant great research consideration. The requirements that these biomarkers must fulfil for use as practical clinical tools have not yet been adequately investigated. Aim: To identify the core elements of high-quality AD and PSO biomarkers to prepare recommendations for current biomarker research. Method: A cross-sectional two-round Delphi survey was conducted from August to October 2019 and October to November 2020. All participants were members of the BIOMAP project, an EU-funded consortium of clinicians, researchers, patient organizations and pharmaceutical industry partners. The first round consisted of three open-ended questions. Responses were qualitatively analysed, and 26 closed statements were developed. For the second round, ‘agreement’ was assumed when the responses of ≥70% of the participants were ≥5 points on a 7-point Likert scale for each statement. Priority classification was based on mean scores (<20th percentile = low, 20th to 60th percentile = medium, >60th percentile = high). Results: Twenty-one and twenty-six individuals participated in rounds one and two, respectively. From 26 statements that were included in round 2, 18 achieved agreement (8 concerning the performance, 8 for the purpose and 2 on current obstacles). Seven statements were classified as high priority, e.g. those concerning reliability, clinical validity, a high positive predictive value, prediction of the therapeutic response and disease progression. Another seven statements were assigned medium priority, e.g. those about analytical validity, prediction of comorbidities and therapeutic algorithm. Low priority included four statements, like those concerning cost effectiveness and prediction of disease flares. Conclusion: The core requirements that experts agreed on being essential for high-quality AD and PSO biomarkers require rapid validation. Biomarkers can therefore be assessed based on these prioritized requirements.

AB - Background: Chronic inflammatory skin diseases such as atopic dermatitis (AD) and psoriasis (PSO) present major challenges in health care. Thus, biomarkers to identify disease trajectories and response to treatments to improve the lives of affected individuals warrant great research consideration. The requirements that these biomarkers must fulfil for use as practical clinical tools have not yet been adequately investigated. Aim: To identify the core elements of high-quality AD and PSO biomarkers to prepare recommendations for current biomarker research. Method: A cross-sectional two-round Delphi survey was conducted from August to October 2019 and October to November 2020. All participants were members of the BIOMAP project, an EU-funded consortium of clinicians, researchers, patient organizations and pharmaceutical industry partners. The first round consisted of three open-ended questions. Responses were qualitatively analysed, and 26 closed statements were developed. For the second round, ‘agreement’ was assumed when the responses of ≥70% of the participants were ≥5 points on a 7-point Likert scale for each statement. Priority classification was based on mean scores (<20th percentile = low, 20th to 60th percentile = medium, >60th percentile = high). Results: Twenty-one and twenty-six individuals participated in rounds one and two, respectively. From 26 statements that were included in round 2, 18 achieved agreement (8 concerning the performance, 8 for the purpose and 2 on current obstacles). Seven statements were classified as high priority, e.g. those concerning reliability, clinical validity, a high positive predictive value, prediction of the therapeutic response and disease progression. Another seven statements were assigned medium priority, e.g. those about analytical validity, prediction of comorbidities and therapeutic algorithm. Low priority included four statements, like those concerning cost effectiveness and prediction of disease flares. Conclusion: The core requirements that experts agreed on being essential for high-quality AD and PSO biomarkers require rapid validation. Biomarkers can therefore be assessed based on these prioritized requirements.

UR - http://www.scopus.com/inward/record.url?scp=85132071727&partnerID=8YFLogxK

U2 - 10.1111/jdv.18178

DO - 10.1111/jdv.18178

M3 - Article

C2 - 35470457

AN - SCOPUS:85132071727

VL - 36

SP - 1467

EP - 1476

JO - Journal of the European Academy of Dermatology and Venereology

JF - Journal of the European Academy of Dermatology and Venereology

SN - 0926-9959

IS - 9

ER -