Use of Vaccines in Patients Receiving Dupilumab, A Systematic Review and Expert Delphi Consensus Recommendation: A position paper of the American College of Allergy, Asthma and Immunology.

BACKGROUND

Dupilumab is a monoclonal antibody targeting the interleukin (IL)-4 receptor alpha subunit, thus blocking the effects of IL-4 and IL-13, and has shown efficacy in treating various conditions including asthma, atopic dermatitis, eosinophilic esophagitis, and others. Due to its immune modulatory effects, clinical trials studying dupilumab did not allow for patients to receive live vaccines during the clinical trials out of an abundance of caution, and thus package insert recommends patients being treated with dupilumab avoid live vaccines. As dupilumab is now approved down to 6 months of age for the treatment of atopic dermatitis, this reported contraindication is now posing a clinical dilemma for patients and clinicians.

OBJECTIVE

To perform a systematic review of literature on the safety and efficacy of vaccinations in patients receiving dupilumab and to provide expert guidance on the use of vaccines in patients receiving dupilumab.

METHODS

A systematic review of the literature was performed, and an expert Delphi Panel was conducted.

RESULTS

The available literature on patients who received vaccinations while on dupilumab overall suggests that live vaccines are safe and the vaccine efficacy, in general, is not affected by dupilumab. The expert Delphi panel agreed on the use of vaccines in patients on dupilumab was likely safe and effective.

CONCLUSION

Vaccines (including live vaccines) can be administered to patients on dupilumab in a shared decision-making capacity.

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Disclosures of Conflict of Interests JAL – Consultant to ARS, Aquestive, Bryn, ALK, Novartis; Research money to institution from DBV; Adjudication for Abvie, Siolta. Co-Chair Joint Task Force for Practice Parameters. DKC – Reports no conflicts of interest relevant to this manuscript. TA – Reports no conflicts of interest relevant to this manuscript. TED – The project described was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health, under Award Number 2UL1TR001425 - 05A1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. EMA - Employee of Public Health Agency of Canada (PHAC), but the views in any paper are her own and not those of PHAC. Board member of the Canadian Society of Allergy and Clinical Immunology and Head of Allergy Section, Canadian Pediatric Society AA – Institutional funding (Novartis), Advisory Board member (Ready,set,food, Novartis, Genentech), consultation/speaker fees (ALK, EPG Health, MJH, Adelphi, Genentech,FARE, Medscape). KGB – Grants from NIH (R01AI150295), AHRQ (R01HS029319), and Thermo Fisher Scientific. Royalties from UptoDate. Consulting for Denali Therapeutics. MB – Investigator and advisory boards for Regeneron and Sanofi. NMC – Clinical investigator/research support from AstraZeneca, Genentech, Kenota Health. Advisor, Consultant, and/or Speaker for Amgen, ARS Pharma, AstraZeneca, Blueprint Medicines, Bryn Pharma LLC, Freed AI, Genentech, GSK, Hikma, Incyte, Novartis, Regeneron, Sanofi. DBKG - Consultant for Novartis, Aquestive, CellDex, and Kokua. Clinical trials support from Genentech, Novartis, Pfizer, GSK, Merck, Regeneron, Allergy Therapeutics, Eli Lilly, and AstraZeneca. Royalties from UpToDate. NLH –Speaker Adma Bio and Takeda. Speaker and advisor for Pharming, Horizon/Amgen, Horizon Pharmaceuticals/Amgen—Advisory board and speaker JRH – TH – Reports no conflicts of interest relevant to this manuscript MGL – Research money to institution from Regeneron DAK – Reports no conflicts of interest relevant to this manuscript TDM – Reports no conflicts of interest relevant to this manuscript SSM - Speaker: Genentech, Regeneron/Sanofi, GSK, AstraZeneca Grant: Takeda JJO – Consultant/Advisor: GSK, Aquestive, Amgen, and ARS. Adjudication/DSMB: AZ, Novartis, GSK, Sanofi, and AbbVie. Reviewer/Editor: Executive Editor, Annals of Allergy, Asthma & Immunology; Reviewer, UpToDate; Executive Editor, Medscape. Research/Grants: NIH EJP – Reports no conflicts of interest relevant to this manuscript AR - Speakers Bureau for Sanofi/Regeneron, GSK, and AstraZeneca NLR - Received funding from the Jeffrey Modell Foundation (58293-I), the National Institutes of Health (R21AI164100), and Takeda Pharmaceuticals. Consultant for Takeda, Pharming Healthcare, and CSL Behring; and receives royalties from Wolters Kluwer and UpToDate. LS - Clinical investigator for Regeneron and DBV Technologies, and advisor for Sanofi and Leo pharmaceuticals MSS - Member and co-chair of the Joint Task Force on Practice Parameters, serves on the editorial board of The Journal of Allergy and Clinical Immunology In Practice, is an associate editor of Annals of Allergy, Asthma, and Immunology, serves on the board of directors of the American Academy of Allergy, Asthma, and Immunology (views expressed are his own), and has participated in research that has received funding from DBV JMS – Grant support from and consultant for Regeneron/Sanofi CAS - Recipient of a AAAAI Foundation Faculty Development Award. The views expressed in this work are the responsibility of the authors and do not necessarily represent the official views of the AAAAI. DRS – Consultant to ARS JW - Research support from NIAID, Aimmune, DBV Technologies, and Siolta; consultancy fees from ALK Abello, DBV Technologies, and Novartis. MJG – Consultant for Aquestive; is a member of physician/medical advisory boards for DBV Technologies, Sanofi/Regeneron, Nutricia, Novartis, Acquestive, Allergy Therapeutics, AstraZeneca, ALK-Abello, Bryn, Genentech, and Prota; is an unpaid member of the scientific advisory council for the National Peanut Board and 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 the senior associate editor for the Annals of Allergy, Asthma, and Immunology, and is member of the Joint Taskforce on Allergy Practice Parameters. He has received honorarium for lectures from ImSci, Red Nucleus, Medscape, Paradigm Medical Communications, Kaplan, Food Allergy Research and Education, and multiple state/local allergy societies.