Treat-to-Target in Atopic Dermatitis: An International Consensus on a Set of Core Decision Points for Systemic Therapies
De Bruin-Weller, Marjolein; Biedermann, Tilo; Bissonnette, Robert; Deleuran, Mette; Foley, Peter; Girolomoni, Giampiero; Hercogová, Jana; Hong, Chih-Ho; Katoh, Norito; Pink, Andrew E; Richard, Marie-Aleth; Shumack, Stephen; Silvestre, Juan F; Weidinger, Stephan
(2021) Acta Dermato-Venereologica, volume 101, issue 2, pp. 1 - 7
(Article)
Abstract
Currently no treat-to-target framework to guide systemic treatment in adults with moderate-to-severe atopic dermatitis exists. We sought to reach international consensus through an eDelphi process on a core set of recommendations for such an approach. Recommendations were developed by an international Steering Committee, spanning 3 areas (Guiding Principles, Decision Making,
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and Outcome Thresholds) and 2 specific time-points; an initial acceptable target at 3 months and an optimal target at 6 months, each based on improvements in patient global assessment plus at least one specific outcome domain. These treat-to-target- orientated recommendations were evaluated by an extended international panel of physicians, nurses and patients. Proposed recommendations were rated using a 9-point Likert scale; for each recommendation, consensus agreement was reached if ≥ 75% of all respondents rated agreement as ≥ 7. Consensus on 16 core recommendations was reached over 2 eDelphi rounds. These provide a framework for shared decision-making on systemic treatment continuation, modification, or discontinuation.
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Keywords: Atopic dermatitis, Consensus, Edelphi, Surveys and questionnaires, Systemic treatment, Treat-to-target, Dermatology, Journal Article
ISSN: 0001-5555
Publisher: Medical Journals Sweden AB
Note: Funding Information: all the healthcare professionals and patient advocates who participated in the eDelphi consultation groups and agreed to be formally acknowledged (listed in Appendix S1; Table SIII1). Funding sources. The logistics of the consensus meetings and eDelphi process were supported by Sanofi Genzyme. Sanofi Genzyme had no influence on the project methodology or interpretation of results or on the content and viewpoints expressed in this manuscript. Manuscript development was commissioned by TREATGermany with the support of an unrestricted grant from Sanofi Genzyme. Disclosure of potential conflicts of interest. MdB-W is co-principal investigator of the Dutch BioDay Registry and serves as a principal investigator in a number of multi-centre clinical trials in atopic dermatitis sponsored by a wide range of pharmaceutical companies; has attended advisory boards and educational events sponsored by Sanofi-Genzyme, Regeneron, AbbVie and Galderma; has received institutional research grants from Sanofi Genzyme; and has performed consultancy roles with Sanofi-Genzyme, Re-generon, LEO Pharma, Eli Lilly, Abbvie, Pfizer, Galderma and UCB, outside the submitted work. TB has received speaker and consultancy fees, and has received institutional research grants from Alk-Abelló, Celgene, Mylan, Novartis, and Phadia-Thermo, outside the submitted work. RB is an employee and shareholder of Innovaderm Research; has received speaker and consultancy fees, and has received institutional research grants from AbbVie, AntibioTx, Aquinox Pharma, Arcutis, Arena Pharma, Asana BioSciences, Bellus Health, Boehringer-Ingelheim, Brickell Biotech, Dermavant, Celgene, Dignity Sciences, Eli Lilly, EMD Serono, Galderma, Glenmark, GSK-Stiefel, Incyte, Kiniksa, Kyowa Kirin, Leo Pharma, Neokera, Novan, Pfizer, Ralexar, Regeneron Pharmaceuticals, Sanofi Genzyme, Sienna and Vitae, outside the submitted work. MD has received speaker fees and served as a consultant, and has received institutional research grants from AbbVie, Almirall, Eli Lilly, Galapagos, LEO Pharma, Meda Pharma, Pfizer, Pierre Fabre, Regeneron Pharmaceuticals, Inc., and Sanofi Genzyme, outside the submitted work. PF has attended advisory boards for Abbvie, Amgen, Celgene, Janssen, Leo Pharma, Lilly, Merck, Novartis, Pfizer, Sun Pharma, UCB Pharma, Valeant, Galderma, GSK, Mayne Pharma, and Sanofi; has served as a consultant to Janssen, Leo Pharma, Lilly, Novartis, Pfizer, UCB Pharma, BMS, Galderma, Hexima, Mayne Pharma, and Roche; has acted as an investigator in clinical trials for Abbvie, Amgen, Boehringer Ingelheim, Celgene, Janssen, Leo Pharma, Lilly, Merck, Novartis, Pfizer, Sun Pharma, UCB Pharma, Valeant, Astra Zeneca, BMS, Botanix, Celtaxsys, CSL, Cutanea, Dermira, Galderma, Genentech, GSK, Hexima, Regeneron Pharmaceuticals Inc., Roche, and Sanofi; has received institutional research grants from Abbvie, Amgen, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Sun Pharma, Galderma, and Sanofi; has received speaker fees or other honoraria from Abbvie, Celgene, Janssen, Leo Pharma, Lilly, Merck, Novartis, Pfizer, UCB Pharma, Valeant, Galderma, GSK, Roche, and Sanofi; and has received travel expenses for attendance at educational meetings from Abbvie, Janssen, Leo Pharma, Lilly, Merck, Novartis, Pfizer, Sun Pharma, Galderma, Roche, and Sanofi, outside the submitted work. GG has been principal investigator in clinical trials sponsored by and/or and has received personal fees from AbbVie, Abiogen, Almirall, Amgen, Biogen, Bristol-Meyers Squibb, Celgene, Celltrion, Eli-Lilly, Genzyme, Leo Pharma, Menlo therapeutics, Novartis, Pfizer, Regeneron, Samsung, Sandoz and Sanofi, outside the submitted work. JH has attended advisory boards for Sanofi Genzyme and Elli Lilly; has acted as an investigator in clinical studies sponsored by Novartis, Amgen, Pfizer, Elli Lilly, and Fresenius Kabi; has served as a consultant to Leo Pharma and Fresenius Kabi; and has received speaker fees from Janssen, Eli Lilly, AbbVie, Novartis, UCB, Sanofi, Aventis, L´Oreal, Sandoz, and Celgene, outside the submitted work. C-HH has received honoraria as a Funding Information: speaker/consultant for Abbvie, Amgen, Bausch Health, Celgene, Eli Lilly, Galderma, Glaxo-Smith-Kline, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi Genzyme, and UCB; and has received grants as an investigator from Abbvie, Amgen, Bausch Health, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Dermavant, Eli Lilly, Galderma, Glaxo-Smith-Kline, Incyte, Janssen, Leo Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, and UCB, outside the submitted work. NK has received honoraria as a speaker/consultant for Sanofi, Maruho, Avvi, Ely-Lilly Japan, Taiho Pharmaceutical, Jansen Pharma, Mitsubishi Tanabe Pharma, and has received grants as an investigator from Sanofi, Ely-Lilly Japan, and Leo Pharma, outside of submitted work. AEP has acted as an advisor and speaker for Sanofi, Abbvie, Lilly, Novartis, Almirall, La-Roche Posay, Leo, UCB, Novartis, and Janssen, outside of submitted work. M-AR has served as the principal investigator in clinical trials sponsored by and/or and has received personal fees from AbbVie, Abiogen, Al-mirall, Amgen, Biogen, Bristol-Meyers Squibb, Celgene, Eli-Lilly, Leo Pharma, Novartis, and Sanofi, outside of submitted work. SS has received has received honoraria as a speaker/consultant for Sanofi, and has received institutional reseach grants as an investigator from Sanofi, outside of submitted work. JFS has served as a consultant and received speaking fees at educational events for Sanofi-Genzyme, Regeneron, Abbvie and Novartis; and has served as the principal investigator in clinical trials sponsored by AbbVie, Amgen, Eli-Lilly, Leo Pharma, Novartis and Pfizer, outside of submitted work. SW is the co-principal investigator of the German Atopic Eczema Registry (TREATGermany) and coordinator of the EU/IMI project BIOMAP (BIOMarkers in Atopic dermatitis and Psoriasis) projects and is an investigator in a number of clinical trials in atopic dermatitis and psoriasis sponsored by a wide range of pharmaceutical companies; has received institutional research grants from Sanofi Genzyme, LEO Pharma and L’Oreal; has acted as a consultant for Sanofi-Genzyme, Regeneron, LEO Pharma, Eli Lilly, Abbvie, Pfizer, Incyte and Novartis; and has lectured at educational events sponsored by Sanofi-Genzyme, Regeneron, LEO Pharma, AbbVie and Galderma, outside of submitted work. Funding Information: The authors would like to acknowledge the key role of Christian Apfelbacher (Institute of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany) for his input in developing and facilitating the eDelphi process. We wish to thank Valentina Guasconi and Stephen McGrath (both from IntraMed Communications, Milan, Italy) for their support in managing the eDelphi process and facilitating the preliminary advisory boards, subsequent consensus meetings and allied logistics. Iain O?Neill (independent medical writer) provided support in manuscript development (funded by Sanofi Genzyme). We also wish to thank all the healthcare professionals and patient advocates who participated in the eDelphi consultation groups and agreed to be formally acknowledged (listed in Appendix S1; Table SIII1). Funding sources. The logistics of the consensus meetings and eDelphi process were supported by Sanofi Genzyme. Sanofi Genzyme had no influence on the project methodology or interpretation of results or on the content and viewpoints expressed in this manuscript. Manuscript development was commissioned by TREATGermany with the support of an unrestricted grant from Sanofi Genzyme. Disclosure of potential conflicts of interest. MdB-W is co-principal investigator of the Dutch BioDay Registry and serves as a principal investigator in a number of multi-centre clinical trials in atopic dermatitis sponsored by a wide range of pharmaceutical companies; has attended advisory boards and educational events sponsored by Sanofi-Genzyme, Regeneron, AbbVie and Galderma; has received institutional research grants from Sanofi Genzyme; and has performed consultancy roles with Sanofi-Genzyme, Regeneron, LEO Pharma, Eli Lilly, Abbvie, Pfizer, Galderma and UCB, outside the submitted work. TB has received speaker and consultancy fees, and has received institutional research grants from Alk-Abell?, Celgene, Mylan, Novartis, and Phadia-Thermo, outside the submitted work. RB is an employee and shareholder of Innovaderm Research; has received speaker and consultancy fees, and has received institutional research grants from AbbVie, AntibioTx, Aquinox Pharma, Arcutis, Arena Pharma, Asana BioSciences, Bellus Health, Boehringer-Ingelheim, Brickell Biotech, Dermavant, Celgene, Dignity Sciences, Eli Lilly, EMD Serono, Galderma, Glenmark, GSK-Stiefel, Incyte, Kiniksa, Kyowa Kirin, Leo Pharma, Neokera, Novan, Pfizer, Ralexar, Regeneron Pharmaceuticals, Sanofi Genzyme, Sienna and Vitae, outside the submitted work. MD has received speaker fees and served as a consultant, and has received institutional research grants from AbbVie, Almirall, Eli Lilly, Galapagos, LEO Pharma, Meda Pharma, Pfizer, Pierre Fabre, Regeneron Pharmaceuticals, Inc., and Sanofi Genzyme, outside the submitted work. PF has attended advisory boards for Abbvie, Amgen, Celgene, Janssen, Leo Pharma, Lilly, Merck, Novartis, Pfizer, Sun Pharma, UCB Pharma, Valeant, Galderma, GSK, Mayne Pharma, and Sanofi; has served as a consultant to Janssen, Leo Pharma, Lilly, Novartis, Pfizer, UCB Pharma, BMS, Galderma, Hexima, Mayne Pharma, and Roche; has acted as an investigator in clinical trials for Abbvie, Amgen, Boehringer Ingelheim, Celgene, Janssen, Leo Pharma, Lilly, Merck, Novartis, Pfizer, Sun Pharma, UCB Pharma, Valeant, Astra Zeneca, BMS, Botanix, Celtaxsys, CSL, Cutanea, Dermira, Galderma, Genentech, GSK, Hexima, Regeneron Pharmaceuticals Inc., Roche, and Sanofi; has received institutional research grants from Abbvie, Amgen, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Sun Pharma, Galderma, and Sanofi; has received speaker fees or other honoraria from Abbvie, Celgene, Janssen, Leo Pharma, Lilly, Merck, Novartis, Pfizer, UCB Pharma, Valeant, Galderma, GSK, Roche, and Sanofi; and has received travel expenses for attendance at educational meetings from Abbvie, Janssen, Leo Pharma, Lilly, Merck, Novartis, Pfizer, Sun Pharma, Galderma, Roche, and Sanofi, outside the submitted work. GG has been principal investigator in clinical trials sponsored by and/or and has received personal fees from AbbVie, Abiogen, Almirall, Amgen, Biogen, Bristol-Meyers Squibb, Celgene, Celltrion, Eli- Lilly, Genzyme, Leo Pharma, Menlo therapeutics, Novartis, Pfizer, Regeneron, Samsung, Sandoz and Sanofi, outside the submitted work. JH has attended advisory boards for Sanofi Genzyme and Elli Lilly; has acted as an investigator in clinical studies sponsored by Novartis, Amgen, Pfizer, Elli Lilly, and Fresenius Kabi; has served as a consultant to Leo Pharma and Fresenius Kabi; and has received speaker fees from Janssen, Eli Lilly, AbbVie, Novartis, UCB, Sanofi, Aventis, L?Oreal, Sandoz, and Celgene, outside the submitted work. C-HH has received honoraria as a speaker/consultant for Abbvie, Amgen, Bausch Health, Celgene, Eli Lilly, Galderma, Glaxo-Smith-Kline, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi Genzyme, and UCB; and has received grants as an investigator from Abbvie, Amgen, Bausch Health, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Dermavant, Eli Lilly, Galderma, Glaxo-Smith-Kline, Incyte, Janssen, Leo Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, and UCB, outside the submitted work. NK has received honoraria as a speaker/consultant for Sanofi, Maruho, Avvi, Ely-Lilly Japan, Taiho Pharmaceutical, Jansen Pharma, Mitsubishi Tanabe Pharma, and has received grants as an investigator from Sanofi, Ely-Lilly Japan, and Leo Pharma, outside of submitted work. AEP has acted as an advisor and speaker for Sanofi, Abbvie, Lilly, Novartis, Almirall, La-Roche Posay, Leo, UCB, Novartis, and Janssen, outside of submitted work. M-AR has served as the principal investigator in clinical trials sponsored by and/or and has received personal fees from AbbVie, Abiogen, Almirall, Amgen, Biogen, Bristol-Meyers Squibb, Celgene, Eli-Lilly, Leo Pharma, Novartis, and Sanofi, outside of submitted work. SS has received has received honoraria as a speaker/consultant for Sanofi, and has received institutional reseach grants as an investigator from Sanofi, outside of submitted work. JFS has served as a consultant and received speaking fees at educational events for Sanofi-Genzyme, Regeneron, Abbvie and Novartis; and has served as the principal investigator in clinical trials sponsored by AbbVie, Amgen, Eli-Lilly, Leo Pharma, Novartis and Pfizer, outside of submitted work. SW is the co-principal investigator of the German Atopic Eczema Registry (TREATGermany) and coordinator of the EU/IMI project BIOMAP (BIOMarkers in Atopic dermatitis and Psoriasis) projects and is an investigator in a number of clinical trials in atopic dermatitis and psoriasis sponsored by a wide range of pharmaceutical companies; has received institutional research grants from Sanofi Genzyme, LEO Pharma and L?Oreal; has acted as a consultant for Sanofi-Genzyme, Regeneron, LEO Pharma, Eli Lilly, Abbvie, Pfizer, Incyte and Novartis; and has lectured at educational events sponsored by Sanofi-Genzyme, Regeneron, LEO Pharma, AbbVie and Galderma, outside of submitted work. Publisher Copyright: © 2021, Medical Journals/Acta D-V. All rights reserved.
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