The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): a clinical outcome measure for the severity of atopic dermatitis

Eric L Simpson, Robert Bissonnette, Amy S Paller, Brett King, Jonathan I Silverberg, Kristian Reich, Jacob P Thyssen, Helen Doll, Luna Sun, Amy M DeLozier, Fabio P Nunes, Lawrence F Eichenfield, Eric L Simpson, Robert Bissonnette, Amy S Paller, Brett King, Jonathan I Silverberg, Kristian Reich, Jacob P Thyssen, Helen Doll, Luna Sun, Amy M DeLozier, Fabio P Nunes, Lawrence F Eichenfield

Abstract

Background: The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) is a standardized severity assessment for use in clinical trials and registries for atopic dermatitis (AD).

Objectives: To investigate the reliability, validity, responsiveness and within-patient meaningful change of the vIGA-AD.

Methods: Data were analysed from adult patients with moderate-to-severe AD in the BREEZE-AD1 (N = 624 patients; NCT03334396), BREEZE-AD2 (N = 615; NCT03334422) and BREEZE-AD5 (N = 440; NCT03435081) phase III baricitinib clinical studies.

Results: Across studies, test-retest reliability for stable patients showed moderate-to-good agreement [range of Kappa values for Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD), 0·516-0·639; for Eczema Area and Severity Index (EASI), 0·658-0·778]. Moderate-to-large correlations between vIGA-AD and EASI or body surface area (range at baseline, 0·497-0·736; Week 16, 0·716-0·893) supported convergent validity. Known-groups validity was demonstrated vs. EASI and PGI-S-AD (vIGA-AD for severe vs. moderate EASI categories at baseline, P < 0·001). Responsiveness was demonstrated vs. EASI (P < 0·001 for much improved vs. improved and improved vs. stable). Anchor- and distribution-based methods supported a vIGA-AD change of -1·0 as clinically meaningful. These findings are limited to populations defined by the studies' inclusion and exclusion criteria.

Conclusions: The vIGA-AD demonstrated sufficient reliability, validity, responsiveness and interpretation standards for use in clinical trials. What is already known about this topic? A description of the development of the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) has been published previously. What does this study add? The current study validates the vIGA-AD by demonstrating appropriate test-retest reliability, convergent validity, known-groups validity and responsiveness across three baricitinib clinical studies. In addition, a 1-point change was identified as a clinically meaningful patient-perceived change minimal clinically important difference in the vIGA-AD. What are the clinical implications of the work? The vIGA-AD is a measure for investigator assessment of atopic dermatitis suitable for use in clinical research.

Conflict of interest statement

E.L.S. reports grants and fees for participation as a consultant and principal investigator from Eli Lilly and Company, LEO Pharma, Pfizer and Regeneron; grants for participation as a principal investigator from Galderma and Merck & Co.; and fees for consultant services from AbbVie, Boehringer Ingelheim, Dermavant Sciences, Incyte, FortéBio, Pierre Fabre and Sanofi‐Genzyme. R.B. is an investigator, consultant, advisory board member, speaker for and/or receives honoraria from AbbVie, Antiobix, Aquinox Pharmaceuticals, Asana, Astellas, Boehringer Ingelheim, Brickell Biotech, Dermavant Sciences, Dermira, Dignity Sciences, Eli Lilly and Company, Galderma, GlaxoSmithKline‐Stiefel, Glenmark, Hoffman‐LaRoche Ltd, Incyte, Kiniksa, LEO Pharma, Neokera, Pfizer, Regeneron, Relaxer, Sanofi, Sienna and Vitae; and is an employee and shareholder of Innovaderm Research. A.S.P. has been an investigator for AbbVie, AnaptysBio, Eli Lilly and Company, Incyte, LEO Pharma and Regeneron, a consultant with honorarium from AbbVie, Almirall, AnaptysBio, Asana Bio, Boehringer Ingelheim, Dermavant Sciences, Dermira, Eli Lilly and Company, Forté, Incyte, LEO Pharma, Novartis, Regeneron and Sanofi, and on a data safety monitoring board with fees from Galderma. B.K. has served on advisory boards and/or is a consultant and/or is a clinical trial investigator for AbbVie, Aclaris Therapeutics, AltruBio, Almirall, AnaptysBio, Arena Pharmaceuticals, Bioniz Therapeutics, Bristol Meyers Squibb, Concert Pharmaceuticals, Dermavant Sciences, Horizon Therapeutics, Eli Lilly and Company, Incyte Corp, LEO Pharma, Otsuka/Visterra, Pfizer, Regeneron, Sanofi‐Genzyme, TWi Biotechnology and Viela Bio. He is on speaker bureaus for Pfizer, Regeneron and Sanofi‐Genzyme. J.I.S. reports honoraria for consultant and advisory board services and for participation as an investigator from Eli Lilly and Company. K.R. has served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Affibody, Almirall, Amgen, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Centocor, Covagen AG, Eli Lilly and Company, Forward Pharma, Fresenius Medical Care, Galapagos, GlaxoSmithKline, Janssen‐Cilag, Kyowa Kirin, LEO Pharma, Medac, Merck Sharp & Dohme, Miltenyi Biotec, Novartis, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Sun Pharma, Takeda, UCB, Valeant and Xenoport. J.P.T. is an advisor for AbbVie, Almirall, Arena Pharmaceuticals, Aslan Pharmaceuticals, Coloplast, Eli Lilly & Co, LEO Pharma, OM Pharma, Pfizer, Regeneron, Sanofi‐Genzyme and Union Therapeutics; a speaker for AbbVie, Almirall, Eli Lilly & Co, LEO Pharma, Pfizer, Regeneron and Sanofi‐Genzyme; and received research grants from Pfizer, Regeneron and Sanofi‐Genzyme. H.D. was an employee of Clinical Outcome Solutions, contracted by Eli Lilly and Company. L.S., A.M.DeL. and F.P.N. are employees of and stockholders in Eli Lilly and Company. L.F.E. reports grants and fees for participation as a consultant and/or investigator from AbbVie, Almirall, Aslan, Dermavant, Dermira, Eli Lilly and Company, Forté Biosciences, Galderma, Incyte, LEO Pharma, Novartis, Pfizer, Regeneron and Sanofi‐Genzyme; and honoraria and fees from Asana and Glenmark for data safety monitoring board services.

© 2022 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

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