Methods of oral immunotherapy
The present disclosure relates to improved oral immunotherapy methods for treating food allergies, and particularly peanut allergy. Biomarkers, such as a level of peanut-specific IgE and/or peanut-specific IgG4s are used by the methods described herein. Such methods include a method of treating a subject for a peanut allergy, methods of assessing the suitability of a treatment for a peanut allergy, a method of evaluating a symptom in a subject during the course of treatment of a peanut allergy, a method of monitoring treatment for a peanut allergy in a subject, a method of reducing the risk or incidence of an adverse event in a subject receiving treatment for a peanut allergy, a method of adjusting a dose of an allergenic peanut composition, and a method of assessing a likelihood of an allergic reaction that requires administration of epinephrine to a subject receiving treatment for a peanut allergy.
1. A method of treating a subject for a peanut allergy, comprising:
measuring a level of peanut-specific IgEs in the subject;
selecting the subject for treatment based on the measured level of peanut-specific IgEs in the subject being at or below a predetermined threshold; and
administering to the selected subject at least one dose of an allergenic peanut composition.
2. The method of claim 1 , wherein the predetermined threshold for the level of peanut-specific IgEs is about 100 kU/L.
3. The method of claim 2 , wherein the level of peanut-specific IgEs is measured prior to initiating treatment of the peanut allergy.
4. The method of claim 2 , wherein the dose is administered to the subject as part of an oral immunotherapy dosing regimen.
5. The method of claim 4 , wherein the dose is administered to the subject during an initial escalation phase of the oral immunotherapy dosing regimen.
6. The method of claim 4 , wherein the dose is administered to the subject during an up-dosing phase of the oral immunotherapy dosing regimen.
7. The method of claim 4 , wherein the dose is administered to the subject during a maintenance phase of the oral immunotherapy dosing regimen.
8. A method of treating a subject for a peanut allergy, comprising:
measuring a level of peanut-specific IgEs in the subject;
administering to the subject at least one dose of an allergenic peanut composition;
determining whether the subject is in need of heightened monitoring for an allergic reaction based on the measured level of peanut-specific IgEs in the subject being above a predetermined threshold; and
monitoring the subject for an allergic reaction, wherein the monitoring is heightened compared to a subject having a level of peanut-specific IgEs at or below the predetermined threshold.
9. A method of adjusting a dose of an allergenic peanut composition, comprising:
administering a first dose of the allergenic peanut composition to a subject with a peanut allergy;
measuring a level of peanut-specific IgEs in the subject after administration of the first dose;
selecting a second dose of the allergenic peanut composition based on the first dose and the measured level of peanut-specific IgEs in the subject; and
administering the second dose of the allergenic peanut composition to the subject.
10. The method of claim 1 , wherein the subject is a human.
11. The method of claim 1 , wherein the subject is about 17 years of age or younger.
12. The method of claim 11 , wherein the subject is about 4 years of age to about 17 years of age.
13. The method of claim 1 , wherein the level of peanut-specific IgEs corresponds to a level as measured by a fluorescence enzyme immunoassay auto-analyzer.
14. The method of claim 1 , wherein the level of peanut-specific IgEs is measured by a fluorescence enzyme immunoassay auto-analyzer.
15. The method of claim 8 , wherein the predetermined threshold of the level of peanut-specific IgEs is about 100 kU/L.
16. The method of claim 8 , wherein heightened monitoring comprises a longer clinical visit following administration of the dose compared to a subject having a level of peanut-specific IgEs at or below the predetermined threshold.
17. The method of claim 8 , wherein heightened monitoring comprises active monitoring for the allergic reaction.
18. The method of claim 17 , wherein active monitoring comprises measuring a heart rate, blood pressure, respiratory rate, or blood oxygen.
19. The method of claim 8 , wherein the allergic reaction is hypersensitivity, anaphylaxis, a gastrointestinal symptom, or eosinophilic esophagitis.
20. The method of claim 8 , wherein the dose is administered to the subject as part of an oral immunotherapy dosing regimen.
21. The method of claim 20 , wherein the dose is administered to the subject during an initial escalation phase of the oral immunotherapy regimen.
22. The method of claim 20 , wherein the dose is administered to the subject during an up-dosing phase of an oral immunotherapy regimen.
23. The method of claim 20 , wherein the dose is administered to the subject during a maintenance phase of an oral immunotherapy regimen.
24. The method of claim 8 , wherein the level of peanut-specific IgEs in the subject is measured prior to initiating treatment of the subject.
25. The method of claim 8 , wherein the level of peanut-specific IgEs in the subject is measured during the course of treatment.
26. The method of claim 8 , wherein the subject is a human.
27. The method of claim 8 , wherein the subject is about 17 years of age or younger.
28. The method of claim 27 , wherein the subject is about 4 years of age to about 17 years of age.
29. The method of claim 8 , wherein the level of peanut-specific IgEs corresponds to a level as measured by a fluorescence enzyme immunoassay auto-analyzer.
30. The method of claim 8 , wherein the level of peanut-specific IgEs is measured by a fluorescence enzyme immunoassay auto-analyzer.
31. The method of claim 9 , wherein the second dose is lower than the first dose if the level of peanut-specific IgEs is above a predetermined threshold.
32. The method of claim 9 , wherein administration of the second dose is delayed if the level of peanut-specific IgEs is above a predetermined threshold.
33. The method of claim 9 , wherein the second dose is the same as the first dose if the level of peanut-specific IgEs is above a predetermined threshold.
34. The method of claim 9 , wherein the second dose is increased relative to the first dose if the level of peanut-specific IgEs is at or below the predetermined threshold.
35. The method of claim 31 , wherein the predetermined threshold is about 100 kU/L.
36. The method of claim 32 , wherein the predetermined threshold is about 100 kU/L.
37. The method of claim 33 , wherein the predetermined threshold is about 100 kU/L.
38. The method of claim 34 , wherein the predetermined threshold is about 100 kU/L.
39. The method of claim 9 , wherein the subject is a human.
40. The method of claim 9 , wherein the subject is about 17 years of age or younger.
41. The method of claim 40 , wherein the subject is about 4 years of age to about 17 years of age.
42. The method of claim 9 , wherein the level of peanut-specific IgEs corresponds to a level as measured by a fluorescence enzyme immunoassay auto-analyzer.
43. The method of claim 9 , wherein the level of peanut-specific IgEs is measured by a fluorescence enzyme immunoassay auto-analyzer.