The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis - 19/08/20
Doi : 10.1016/j.jaad.2020.04.104
Eric Simpson, MD a, ⁎ 
, Robert Bissonnette, MD b, Lawrence F. Eichenfield, MD c, Emma Guttman-Yassky, MD, PhD d, Brett King, MD, PhD e, Jonathan I. Silverberg, MD, PhD, MPH f, Lisa A. Beck, MD g, Thomas Bieber, MDRA, MD, PhD h, Kristian Reich, MD, PhD i, Kenji Kabashima, MD, PhD j, Marieke Seyger, MD, PhD k, Elaine Siegfried, MD l, Georg Stingl, MD m, Steven R. Feldman, MD, PhD n, Alan Menter, MD o, Peter van de Kerkhof, MD, PhD k, Gil Yosipovitch, MD p, Carle Paul, MD, PhD q, Philippe Martel, MD, PhD r, s, Ariane Dubost-Brama, MD r, John Armstrong, PhD r, Rajeev Chavda, MD r, Steve Frey, MS t, Yolandi Joubert, MSc u, Marina Milutinovic, MD u, Anne Parneix, MD v, Henrique D. Teixeira, PhD, MBA w, Chen-Yen Lin, PhD s, Luna Sun, PhD s, Paul Klekotka, MD, PhD s, Brian Nickoloff, MD, PhD s, Yves Dutronc, MD s, Lotus Mallbris, MD, PhD s, Jonathan M. Janes, FRCP, MFPM s, Amy M. DeLozier, MPH s, Fabio P. Nunes, MD, MMSc s, Amy S. Paller, MD f
, Robert Bissonnette, MD b, Lawrence F. Eichenfield, MD c, Emma Guttman-Yassky, MD, PhD d, Brett King, MD, PhD e, Jonathan I. Silverberg, MD, PhD, MPH f, Lisa A. Beck, MD g, Thomas Bieber, MDRA, MD, PhD h, Kristian Reich, MD, PhD i, Kenji Kabashima, MD, PhD j, Marieke Seyger, MD, PhD k, Elaine Siegfried, MD l, Georg Stingl, MD m, Steven R. Feldman, MD, PhD n, Alan Menter, MD o, Peter van de Kerkhof, MD, PhD k, Gil Yosipovitch, MD p, Carle Paul, MD, PhD q, Philippe Martel, MD, PhD r, s, Ariane Dubost-Brama, MD r, John Armstrong, PhD r, Rajeev Chavda, MD r, Steve Frey, MS t, Yolandi Joubert, MSc u, Marina Milutinovic, MD u, Anne Parneix, MD v, Henrique D. Teixeira, PhD, MBA w, Chen-Yen Lin, PhD s, Luna Sun, PhD s, Paul Klekotka, MD, PhD s, Brian Nickoloff, MD, PhD s, Yves Dutronc, MD s, Lotus Mallbris, MD, PhD s, Jonathan M. Janes, FRCP, MFPM s, Amy M. DeLozier, MPH s, Fabio P. Nunes, MD, MMSc s, Amy S. Paller, MD f a Oregon Health and Science University, Portland, Oregon
b Innovaderm Research Inc, Montréal, Canada
c University of California San Diego, San Diego, California
d Mount Sinai School of Medicine, New York, New York
e Yale School of Medicine, New Haven, Connecticut
f The George Washington University School of Medicine and Health Sciences, Washington, DC
g University of Rochester Medical Center, Rochester, New York
h University of Bonn, Bonn, Germany
i Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf; Skinflammation Center Hamburg, Hamburg, Germany
j Kyoto University, Kyoto, Japan
k Radboud University Medical Center, Nijmegen, The Netherlands
l Saint Louis University, Saint Louis, Missouri
m Medical University of Vienna, Vienna, Austria
n Wake Forest School of Medicine, Winston-Salem, North Carolina
o Baylor Scott & White Health, Dallas, Texas
p University of Miami, Miami, Florida
q Toulouse University, Toulouse, France
r Galderma, Sophia Antipolis, France
s Eli Lilly and Company, Indianapolis, Indiana
t GlaxoSmithKline, Collegeville, Pennsylvania
u Novartis Pharma AG, Basel, Switzerland
v Novartis Pharmaceuticals Corporation, East Hanover, New Jersey
w AbbVie Inc, North Chicago, Illinois
∗Reprint requests: Eric Simpson, MD, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239.Oregon Health & Science University3181 SW Sam Jackson Park RdPortlandOR97239
Abstract |
Background |
An Investigator Global Assessment (IGA) is recommended by health agencies for drug registration in atopic dermatitis (AD). Current IGA scales lack standardization.
Objectives |
To develop an IGA scale, training module, and clinical certification examination for use in AD trials; establish content validity; and assess reliability.
Methods |
Expert dermatologists participated in the development of the validated IGA for AD (vIGA-ADTM). Reliability (interrater and intrarater) was assessed by 2 web-based surveys. Clinical certification for investigators consisted of a training module and examination.
Results |
Expert consensus was achieved around a 5-point IGA scale including morphologic descriptions, and content validity was established. Survey 1 showed strong interrater reliability (Kendall's coefficient of concordance W [Kendall's W], 0.809; intraclass correlation [ICC], 0.817) and excellent agreement (weighted kappa, 0.857). Survey 2, completed 5 months after training of dermatologists, showed improvements in scale reliability (Kendall's W, 0.819; ICC, 0.852; weighted kappa, 0.889). In this study, 627 investigators completed vIGA-AD training and certification.
Limitations |
Ratings were assessed on photographs.
Conclusion |
A validated IGA scale and training module were developed with the intent of harmonizing assessment of disease severity in AD trials. Strong reliability and excellent agreement between assessments were observed.
Le texte complet de cet article est disponible en PDF.Key words : atopic dermatitis, atopic eczema, clinical outcome measure, Investigator Global Assessment, severity, validated
Abbreviations used : AD, BSA, EASI, FDA, ICC, IGA, SCORAD, vIGA-AD
Plan
| Funding sources: Supported by Eli Lilly and Company. |
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| Disclosure: Dr Simpson 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, Incyte, Forte Bio, Pierre Fabre Dermo, and Sanofi Genzyme. Dr Bissonnette is an investigator, consultant, advisory board member, and/or speaker for and/or receives honoraria from AbbVie, Aquinox Pharma, Antiobix, Asana, Astellas, Boehringer Ingelheim, Brickell Biotech, Dermavant, Dermira, Dignity Sciences, Eli Lilly and Company, Galderma, Glenmark, GlaxoSmithKline-Stiefel, Hoffman-LaRoche Ltd, Incyte, Kiniksa, LEO Pharma, Neokera, Pfizer, Relaxer, Regeneron, Sanofi, Sienna, and Vitae and is an employee and shareholder of Innovaderm Research. Dr Eichenfield reports grants and fees for participation as a consultant and investigator from AbbVie, Eli Lilly and Company, Incyte, LEO Pharma, Pfizer, and Regeneron; fees for consulting services from Allergan, Dermavant, Dermira, Forte Bio, Galderma, Matrisys, Novartis, Regeneron, and Sanofi Genzyme; and honoraria and fees from Asana, Eli Lilly and Company, and Glenmark for data safety monitoring board services. Dr Guttman-Yassky is a consultant for AbbVie, Almirall, Amgen, Asana Biosciences, Boehringer Ingelheim, Cara Therapeutics, Celgene, Concert, DBV Technologies, Dermira, DS Biopharma, Eli Lilly and Company, EMD Serono, Escalier, Galderma, Glenmark, Kyowa Kirin, LEO Pharma, Mitsubishi Tanabe, Pfizer, RAPT Therapeutics, Regeneron, Sanofi, Sienna Biopharma, and Union Therapeutics and reports institute grants for research from AbbVie, Almirall, Amgen, AnaptysBio, Asana Biosciences, Boehringer Ingelheim, Celgene, Dermavant, DS Biopharma, Eli Lilly and Company, Glenmark, Galderma, Innovaderm, Janssen, Kiniksa, Kyowa Kirin, Leo Pharma, Novan, Pfizer, Ralexar, Regeneron, Sienna Biopharma, UCB, and Union Therapeutics. Dr King reports honoraria and/or fees for service on advisory boards and/or as consultant and/or as clinical trial investigator for Aclaris Therapeutics, Arena Pharmaceuticals, Bristol-Meyers Squibb, Concert Pharmaceuticals Inc, Dermavant Sciences, Eli Lilly and Company, and Pfizer Inc and is on the speaker's bureau for Pfizer Inc, Regeneron, and Sanofi Genzyme. Dr Silverberg reports honoraria for consultant and advisory board services and for participation as an investigator from Eli Lilly and Company. Dr Beck reports honoraria for advisory board or consulting services from AbbVie, Allakos, Arena Pharmaceuticals, AstraZeneca, Connect Biopharma, Eli Lilly and Company, LEO Pharma, Novan, Novartis, Pfizer, Regeneron, Sanofi, UCB, and Vimalan; reports grants for services as an investigator from AbbVie, LEO Pharma, Pfizer, and Regeneron; and owns stock in Pfizer and Medtronic. Dr Bieber reports honoraria for advisory board and/or consultancy services from AbbVie, Almirall, AnaptysBio, Arena Pharmaceuticals, Asana, Daiichi-Sankyo, Dermavant, Galapagos, GlaxoSmithKline, Glenmark Pharma, Incyte, Kymab, Kyowa Hakko Kirin, LEO Pharma, Menlo Therapeutics, Novartis, and Regeneron/Sanofi. Dr Reich 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, Eli Lilly and Company, Forward Pharma, Fresenius Medical Care, Galapagos, GlaxoSmithKline, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Medac, Merck Sharp & Dohme, Novartis, Miltenyi Biotec, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Sun Pharma, Takeda, UCB, Valeant, and Xenoport. Dr Kabashima has received honoraria and/or grant support from Japan Tobacco, LEO Pharma, Maruho, Mitsubishi Tanabe, Ono, P&G, and Taiho; consultant fees from Sanofi; and fees for lectures from Toril. Dr Seyger reports grant funding/was involved in clinical trials from AbbVie, Eli Lilly and Company, Janssen, and LEO Pharma and has served as a consultant for AbbVie, Eli Lilly and Company, Janssen, LEO Pharma, and Pfizer; fees were paid directly to the institute. Dr Siegfried was a paid consultant for Eli Lilly and Company during the conduct of the study and has been a paid investigator and/or consultant outside of the submitted work for AbbVie, Amgen, Anacor, Dermavant, Janssen, LEO Pharma, Novan, Pfizer, Pierre Fabre, Regeneron, Sanofi Genzyme, UCB, Valeant, and Verrica. Dr Stingl reports honoraria for lectures from AbbVie, Eli Lilly and Company, Janssen, Novartis, and Sanofi; honoraria for advisory services from AbbVie, Eli Lilly and Company, Incyte, and Janssen; and honoraria for consultancy services from Janssen and Sanofi. Dr Feldman reports honoraria and grants for consulting, speaking, and research from Celgene, Eli Lilly and Company, Novartis, and Ortho Dermatology; honoraria for consulting and speaking from Janssen and LEO Pharma; honoraria for speaking from AbbVie; honoraria for consultancy services from Almirall and Samsung; and honoraria for advisory services from Boehringer Ingelheim and Merck & Co. Dr Menter reports honoraria and grants for consultant, speaking, investigator, and advisory services from Abbott Laboratories, Amgen, Janssen, LEO Pharma, and Sienna; honoraria and grants for advisory and investigator services from Boehringer Ingelheim; honoraria for investigator and consultancy services from Eli Lilly and Company and Novartis; honoraria for consultant, speaker, and investigator services from UCB; and grants for investigator services from Celgene and Merck & Co. Dr van de Kerkhof reports consultancy services for AbbVie, Almirall, Amgen, Bristol-Myers Squibb, Celgene, Centocor, Dermavant, Eli Lilly and Company, Galderma, Janssen, LEO Pharma, Novartis, Pfizer, Philips, Sandoz, Sandoz, and UCB. Dr Yosipovitch reports consulting support and research grants from Bellus, Eli Lilly and Company, Galderma, Kiniksa, Menlo, Novartis, Pfizer, Sanofi/Regeneron, Leo, Sun Pharma, and Trevi. Dr Paul reports honoraria and grants for consultancy services from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Janssen, LEO Pharma, Novartis, Pierre Fabre, and Sanofi/Regeneron. Dr Martel was an employee of Eli Lilly and Company and Galderma at the time of this study. Author Frey is an employee of GlaxoSmithKline Pharmaceuticals. Author Joubert is an employee of and stockholder in Novartis Pharma AG. Dr Milutinovic is an employee of and stockholder in Novartis Pharma AG. Dr Parneix is an employee of and stockholder in Novartis Pharmaceuticals Corporation. Dr Teixeira is an employee of and stockholder in AbbVie. Drs Lin, Sun, Klekotka, Nickoloff, Dutronc, Mallbris, Janes, Author DeLozier, and Dr Nunes are employees of and stockholders in Eli Lilly and Company. Dr Paller reports grants from AbbVie, AnaptysBio, Castle Creek, Eli Lilly and Company, Galderma, Incyte, LEO Pharma, Janssen, Novartis, and Regeneron and personal fees from AbbVie, Amgen, Asana, Castle Creek, Dermavant, Dermira, Eli Lilly and Company, Forte, Galderma, LEO Pharma, Matrisys, Menlo, Morphosys/Galapagos, Novartis, Patagonia, Pfizer, Pierre Fabre, Regeneron, Sanofi, and UCB. Drs Dubost-Brama, Armstrong, and Chavda have no conflicts of interest to declare. |
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| Presented at the 27th European Academy of Dermatology and VenereologyCongress; Paris, France; September 12-16, 2018. |
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| IRB approval status: Not applicable. |
© 2020
Publié par Elsevier Masson SAS.
Vol 83 - N° 3
P. 839-846 - septembre 2020 Retour au numéro
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