Observation time after dupilumab injection
Question:
10/4/2024
Do you recommend a wait time after giving specifically Dupixent? A previous Ask the Expert said an observation period after Dupixent is not necessary, is that still the case? I saw in this article https://www.nature.com/articles/s41598-023-44973-z that Omalizumab, benralizumab, and mepolizumab demonstrated positive signals for anaphylactic risk. Additionally, no positive signals related to anaphylactic reactions were observed for dupilumab.
Answer:
Anaphylaxis is most likely to start within 30 minutes of administration of a monoclonal antibody.
Humanized monoclonal antibodies have one of the highest rates of anaphylaxis per dose administered of all medication classes commonly used. The rates are several orders of magnitude higher than the rates of anaphylaxis seen with beta-lactam antibiotics. Estimates on the rate of anaphylaxis after administration of humanized monoclonal antibodies range from 0.1% to 0.3%.
Baddini-Martinez J, Leitão Filho FS, Caetano LSB. Anaphylactic risks associated with immunobiological agents in asthma therapy. Rev Assoc Med Bras (1992). 2023 Feb 20;69(3):367-369.
As you note in the Scientific Reports paper, dupilumab specifically did not demonstrated a positive signal related to anaphylactic reactions over all drugs and monoclonal antibodies, in the individual case safety reports (ICSRs) from the World Health Organization Uppsala Monitoring Center (WHO-UMC) Vigibase of Biologics for asthma.
Park S, Kim Y, Lee GH, Choi SA. A risk of serious anaphylactic reactions to asthma biologics: a pharmacovigilance study based on a global real-world database. Sci Rep. 2023 Oct 17;13(1):17607.
The package insert for dupilumab states:
"A patient may self-inject DUPIXENT after training in subcutaneous injection technique using the pre-filled syringe."
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761055lbl.pdf
I do not recommend a specific waiting time after a dupilumab injection, but it is probably prudent to observe an individual after an office administration of any therapeutic monoclonal antibody as long as one would observe an individual given an immunotherapy injection.
Additionally, as with all self-administered monoclonal antibodies, patients need to be aware of the possibility of anaphylaxis and be able to self-treat for anaphylaxis, should it occur.
Eric Macy, MD, MS, FAAAAI