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. 2024 Jun;153(6):1621-1633.
doi: 10.1016/j.jaci.2024.02.019. Epub 2024 Apr 8.

Preparing Patients for Oral Immunotherapy (PPOINT): International Delphi consensus for procedural preparation and consent

Douglas P Mack  1 , Timothy E Dribin  2 , Paul J Turner  3 , Richard L Wasserman  4 , Mariam A Hanna  5 , Marcus Shaker  6 , Mimi L K Tang  7 , Pablo Rodríguez Del Río  8 , Brad Sobolewski  9 , Elissa M Abrams  10 , Aikaterini Anagnostou  11 , Stefania Arasi  12 , Sakina Bajowala  13 , Philippe Bégin  14 , Scott B Cameron  15 , Edmond S Chan  16 , Sharon Chinthrajah  17 , Andrew T Clark  18 , Paul Detjen  19 , George du Toit  20 , Motohiro Ebisawa  21 , Arnon Elizur  22 , Jeffrey M Factor  23 , Justin Greiwe  24 , Jonathan O'B Hourihane  25 , Sarah W Hughes  26 , Douglas H Jones  27 , Antonella Muraro  28 , Anna Nowak-Wegrzyn  29 , Nandinee B Patel  3 , Amy M Scurlock  30 , Atul N Shah  31 , Sayantani B Sindher  32 , Stephen Tilles  33 , Brian P Vickery  34 , Julie Wang  35 , Hugh H Windom  36 , Matthew Greenhawt  37
Affiliations

Preparing Patients for Oral Immunotherapy (PPOINT): International Delphi consensus for procedural preparation and consent

Douglas P Mack et al. J Allergy Clin Immunol. 2024 Jun.

Abstract

Background: Despite the promise of oral immunotherapy (OIT) to treat food allergies, this procedure is associated with potential risk. There is no current agreement about what elements should be included in the preparatory or consent process.

Objective: We developed consensus recommendations about the OIT process considerations and patient-specific factors that should be addressed before initiating OIT and developed a consensus OIT consent process and information form.

Methods: We convened a 36-member Preparing Patients for Oral Immunotherapy (PPOINT) panel of allergy experts to develop a consensus OIT patient preparation, informed consent process, and framework form. Consensus for themes and statements was reached using Delphi methodology, and the consent information form was developed.

Results: The expert panel reached consensus for 4 themes and 103 statements specific to OIT preparatory procedures, of which 76 statements reached consensus for inclusion specific to the following themes: general considerations for counseling patients about OIT; patient- and family-specific factors that should be addressed before initiating OIT and during OIT; indications for initiating OIT; and potential contraindications and precautions for OIT. The panel reached consensus on 9 OIT consent form themes: benefits, risks, outcomes, alternatives, risk mitigation, difficulties/challenges, discontinuation, office policies, and long-term management. From these themes, 219 statements were proposed, of which 189 reached consensus, and 71 were included on the consent information form.

Conclusion: We developed consensus recommendations to prepare and counsel patients for safe and effective OIT in clinical practice with evidence-based risk mitigation. Adoption of these recommendations may help standardize clinical care and improve patient outcomes and quality of life.

Keywords: Allergy; Delphi; anaphylaxis; consent; food allergy; oral immunotherapy; patient preparation; risk mitigation; shared decision making.

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Conflict of interest statement

D. P. Mack has provided consultation and speaker services for DBV Technologies (DBV), ALK-Abelló, and Alladapt; and is an investigator for DBV and ALK-Abelló. P. J. Turner reports grants from UK Medical Research Council, NIHR/Imperial BRC, and J. M. Charitable Foundation; and personal fees from UK Food Standards Agency, Aimmune Therapeutics, Allergenis, and Aquestive Therapeutics outside the submitted work. R. L. Wasserman has provided consultation and advisory board services to Aimmune. M. A. Hanna is an investigator for DBV and ALK-Abelló. M. Shaker has participated in research funded by DBV; is an associate editor for Annals of Allergy, Asthma & Immunology; is a member of the Joint Task Force on Practice Parameters; and serves on the editorial boards of the Journal of Allergy and Clinical Immunology: In Practice and the Journal of Food Allergy. M. L. K. Tang reports consultant fees from Pfizer and Novartis; past employee (ended July 2022) and share interest/options in Prota Therapeutic; member of medical advisory board of Anaphylaxis & Anaphylaxis Australia; on the board of directors of Asia Pacific Association of Allergy Asthma and Clinical Immunology; past member of the board of directors of the World Allergy Organization (WAO; ended 2019); membership of expert committees of the American Academy of Allergy Asthma and Immunology (AAAAI), Asia Pacific Association of Allergy Asthma and Clinical Immunology (APAAACI), and Australasian Society of Clinical Immunology and Allergy (ASCIA); past membership of expert committees of WAO (ended 2019); and past membership of the International Union of Immunological Societies (ended 2019). P. Rodríguez del Río reports research grants from FAES and Aimmune Therapeutics; speaker honoraria from DBV, GSK, FAES, Novartis, ALK-Abelií, LETI Pharma, Aimmune Therapeutics, Sanofi Regeneron, and Stallergenes; and consultant fees from FAES and Miravo outside the submitted work. E. M. Abrams is a member of Joint Task Force on Practice Parameters; is an editorial board member of the Journal of Allergy and Clinical Immunology: In Practice; serves on the board of directors of the Canadian Society of Allergy and Clinical Immunology (CSACI); and is an employee of Public Health Agency of Canada (views expressed are her own and not those of PHAC). A. Anagnostou has received institutional funding from Aimmune and Novartis; consultation/speaker fees from ALK-Abelló, EPG Health, MJH, Adelphi, Aimmune Therapeutics, Genentech, and Food Allergy Research and Education (FARE); and served as an advisory board member for Ready,set,food and Novartis. S. Arasi has participated as advisory board member, consultant, and/or speaker for Novartis, Aimmune, DBV, Ferrero, and Ulrich outside the submitted work. S. Bajowala has served as consultant and advisory board member for Novartis; has served as a volunteer medical advisory board member of FPIES Foundation; is a shareholder of Solid Starts LLC; and owns WisePrince LLC (medical technology for oral immunotherapy [OIT]). P. Bégin reports grants from Novartis, Sanofi Regeneron, ALK-Abelló, and DBV; and personal fees from Bausch Health, Pfizer, AstraZeneca, DBV, Novartis, Sanofi Regeneron, and ALK-Abelló. S. B. Cameron reports membership on advisory boards for Medexus, Sanofi Regeneron, Bausch Health, Pfizer, and Alladapt; and served as a committee member for the CSACI OIT guidelines. E. S. Chan has received research support from DBV; has been a member of advisory boards for Pfizer, Miravo, Medexus, Leo Pharma, Kaleo, DBV, AllerGenis, Sanofi Genzyme, Bausch Health, Avir Pharma, AstraZeneca, and ALK-Abelló; and was colead of the CSACI OIT guidelines. S. Chinthrajah reports grants from National Institute of Allergy and Infectious Diseases (NIAID), Consortium of Food Allergy Research (CoFAR), FARE, Stanford Maternal and Child Health Research Institute, Genentech, and Regeneron; and personal fees from Alladapt Therapeutics, Novartis, Genentech, Allergenis, Intrommune Therapeutics, IgGenix, and Phylaxis. A. T. Clark is chief medical officer and stockholder in Camallergy Ltd (manufacturer of food OIT products). G. du Toit has received grants from NIAID, NIH, FARE, MRC & Asthma UK Centre, Action Medical Research, and National Peanut Board; was scientific advisory board member for Aimmune and Novartis; and was an investigator on pharma-sponsored allergy studies for Aimmune, DBV, and Novartis. J. Greiwe has provided speaker services for AbbVie, AstraZeneca, Incyte, Mylan, Regeneron, and Sanofi Genzyme; and has served on advisory boards for AbbVie, Aimmune, ALK-Abelló, AstraZeneca, DBV, Dermavant, Genentech, GSK, Regeneron, and Sanofi Genzyme. J. O’B Hourihane reports consultancy and research funding for Aimmune Therapeutics; research funding from DBV, Johnson & Johnson, Temple St Foundation, Ireland, City of Dublin Skin and Cancer Hospital Charity, and National Children’s Research Centre, Ireland; board membership for Clemens Von Pirquet Foundation Irish Food Allergy Network; and patent applications for Johnson & Johnson. D. H. Jones reports being consultant, speaker, and/or member of advisory boards for Genentech, Novartis, AstraZeneca, and Sanofi Regeneron. A. Muraro is a principal investigator (PI) for Aimmune, DBV, Novartis, Sanofi Regeneron; and has served on advisory boards and/or received speaker fees from Aimmune, DBV, Novartis, Sanofi Regeneron, Viatris, ALK-Abelló, Nestlé Heath Science, and Nutricia Danone. A. Nowak-Wegrzyn reports receipt of research support from NIAID, DBV, Alladapt, Danone and Nestle; receipt of consultancy fees from Regeneron, Novartis, Thermo Fisher Scientific, Aquestive, and Aimmune; and service as associate editor for Annals of Allergy, Asthma & Immunology; director of American Academy of Allergy, Asthma and Immunology board of directors; and chair of medical advisory board of International FPIES Association. N. B. Patel reports grants from UK Medical Research Council, NIHR/Imperial BRC, and J. M. Charitable Foundation; and personal fees from UK Food Standards Agency, Aimmune Therapeutics, Allergenis, Aquestive Therapeutics and Novartis outside of the submitted work. A. M. Scurlock receives grant funding from NIH/NIAID (CoFAR), FARE; and clinical trial funding from Aimmune Therapeutics, DBV, Genentech, Novartis, Siolta Therapeutics, and Regeneron Therapeutics. S. B. Sindher has received grant support to conduct trials from the National Institutes of Health, DBV, Regeneron, Aimmune, Novartis, CoFAR, and FARE; and is advisor/consultant for Genentech and DBV. S. Tilles is an employee of Aimmune Therapeutics. B. P. Vickery reports grants from Alladapt, AstraZeneca, Genentech, NIAID/NIH, and Siolta; personal fees from Allergenis, Aravax, Reacta Biosciences, and Sanofi Regeneron; both grants and personal fees from Aimmune, DBV, FARE, Novartis, and Regeneron; and stock options from Moonlight Therapeutics outside the submitted work. J. Wang receives research support from NIAID, Aimmune, DBV, and Siolta; and consultancy fees from ALK-Abelló, DBV, and Novartis. H. H. Windom serves as a PI in clinical trials with Sanofi Regeneron, Novartis, GSK, Areteia, Chiesi, and AstraZeneca. M. Greenhawt is a consultant for Aquestive; is a member of physician/medical advisory boards for DBV, Nutricia, Novartis, Aquestive, Allergy Therapeutics, AstraZeneca, ALK-Abelló, Bryn, Genentech, and Prota; is an unpaid member of the scientific advisory council for the National Peanut Board and the medical advisory board of the International Food Protein Induced Enterocolitis Syndrome Association; is a member of the Brighton Collaboration Criteria Vaccine Anaphylaxis 2.0 working group; is a senior associate editor for Annals of Allergy, Asthma & Immunology; is a member of the Joint Taskforce on Allergy Practice Parameters; and has received honoraria for lectures from ImSci, Red Nucleus, Medscape, Paradigm Medical Communications, and multiple state/local allergy societies. The rest of the authors declare that they have no relevant conflicts of interest.

Figures

FIG 1.
FIG 1.
(A) Theme A key statements regarding general considerations for counseling patients about OIT. (B) Theme B key statements regarding general considerations for counseling patients about OIT. (C) Theme C key statements regarding general considerations for counseling patients about OIT. Statement number and statement are listed. Percentage of participants who voted for statement is represented by number and graphically as blue circle. Blue dots represent number of rounds to reach consensus. Full list of statements is provided in Tables E2–E4.
FIG 2.
FIG 2.
Theme D ranked absolute and relative contraindications that reached consensus. Circle represents statement number. Voting percentages for absolute (red) and relative (yellow) listed in bars. Full list of statements is provided in Table E5.
FIG 3.
FIG 3.
Theme E and F key statements for general considerations for counseling patients about OIT. Statement number and statement are listed. Percentage of participants who voted for statement represented by number and graphically as blue circle. Blue dots represent number of rounds to reach consensus. Median priority to include statement on consent form represented with number and rainbow lever graphic representation. Interquartile range listed below. Full list of statements is provided in Tables E6 and E7.
FIG 4.
FIG 4.
Theme I key statements for practical risk mitigation strategies for OIT. Statement number and statement are listed. Percentage of participants who voted for statement represented by number and graphically as blue circle. Blue dots represent number of rounds to reach consensus. Median priority to include statement on consent form represented with number and rainbow lever graphic representation. Interquartile range listed below. Full list of statements is provided in Table E10.
FIG 5.
FIG 5.
Theme K key statements regarding “OIT may be discontinued by patient or practitioner if…” Statement number and statement are listed. Percentage of participants who voted for statement represented by number and graphically as blue circle. Blue dots represent number of rounds to reach consensus. Median priority to include statement on consent form represented with number and rainbow lever graphic representation. Interquartile range listed below. Full list of statements is provided in Table E12.
FIG 6.
FIG 6.
Proposed flow diagram resulting from procedural and consent elements of PPOINT study. AD, Atopic dermatitis; AR, allergic rhinitis; CSU, chronic spontaneous urticaria; EMA, European Medicines Agency; FDA, US Food and Drug Administration; GAD, general anxiety; GERD, gastroesophageal reflux disease; GI, gastrointestinal; IBD, inflammatory bowel disease; NSAID, nonsteroidal anti-inflammatory; OCD, obsessive-compulsive disorder; QOL, quality of life; SLIT, sublingual immunotherapy.
See this image and copyright information in PMC

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