IP Library Granted Patent US 11,229,673
Granted Patent B2
US 11,229,673 · App. 16/870,696 · Granted Jan 25, 2022

Methods for improving the quality of life of a patient with a peanut allergy

Inventor: Christine Birchwood (East Palo Alto, CA)
Assignee: Société des Produits Nestlé S.A.
A61K36/48A61K9/0053A61P37/08
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Quick Facts
Patent No.
US 11,229,673
App. No.
16/870,696
Granted
Jan 25, 2022
Kind
B2
Abstract

The present disclosure relates to methods of improving the quality of life of a subject having a peanut allergy. In certain embodiments, the disclosure provides methods for improving the quality of life of a subject having a peanut allergy by administering a peanut composition according to an oral immunotherapy schedule. In certain embodiments, the disclosure provides methods for improving the quality of life of a subject having a peanut allergy by informing the subject they are to be, or are being, administered a peanut composition according to an oral immunotherapy schedule.

Claims (34)

1. A method of improving the quality of life of a patient with a peanut allergy, comprising:

administering to the patient a peanut composition according to an oral immunotherapy schedule comprising an up-dosing phase and a maintenance phase; wherein the peanut composition is administered to the patient during the maintenance phase of the oral immunotherapy schedule at a dose of about 300 mg peanut protein.

2. The method of claim 1 , further comprising informing the patient that the peanut composition is being administered to the patient.

3. The method of claim 2 , wherein the patient is informed that the peanut composition is being administered to the patient at the start of the oral immunotherapy schedule.

4. The method of claim 2 , wherein the patient is informed that the peanut composition is being administered to the patient prior to the start of the oral immunotherapy schedule.

5. The method of claim 2 , wherein the patient is informed that the peanut composition is being administered to the patient during the up-dosing phase of an oral immunotherapy schedule.

6. The method of claim 2 , wherein the patient is informed that the peanut composition is being administered to the patient during the maintenance phase of the oral immunotherapy schedule.

7. The method of claim 2 , wherein the method comprises measuring the quality of life after informing the patient that the peanut composition is being administered.

8. The method of claim 1 , wherein the quality of life improvement is measured using a quality of life questionnaire (QoLQ).

9. The method of claim 8 , wherein the QoLQ comprises one or more scored domains of measurement.

10. The method of claim 9 , wherein the QoLQ is a Food Allergy Quality of Life Questionnaire (FAQLQ).

11. The method of claim 10 , wherein the FAQLQ is a FAQLQ-child form (FAQLQ-CF), FAQLQ-teen form (FAQLQ-TF), FAQLQ-adult form (FAQLQ-AF), or FAQLQ-parent form (FAQLQ-PF).

12. The method of claim 9 , wherein the one or more scored domains of the QoLQ are each scored on a scale between 1 and 7, or are each converted to a score between a first score and a second score, wherein the second score indicates worse quality of life.

13. The method of claim 9 , wherein an improvement in the patient's quality of life is at least 0.5 points in one or more domains of the QoLQ at a second time point after a period of oral immunotherapy as compared to an assessment at a first time point before the period of oral immunotherapy.

14. The method of claim 13 , wherein the period of oral immunotherapy between the first time point and the second time point is the up-dosing phase of the oral immunotherapy schedule.

15. The method of claim 13 , wherein the period of oral immunotherapy between the first time point and the second time point is at least 1 month of a maintenance therapy of the oral immunotherapy schedule.

16. The method of claim 9 , wherein an improvement in the patient's quality of life is at least 0.5 points in a total score of the QoLQ at a second time point after a period of oral immunotherapy as compared to an assessment at a first time point before the period of oral immunotherapy; wherein the total score is the average of each domain score.

17. The method of claim 8 , wherein the QoLQ is a Food Allergy Independent Measure (FAIM).

18. The method of claim 17 , wherein the FAIM is a FAIM-child form (FAIM-CF), FAIM-teen form (FAIM-TF), FAIM-adult form (FAIM-AF), or FAIM-parent form (FAIM-PF).

19. The method of claim 1 , wherein the quality of life is improved for at least 6 months.

20. The method of claim 1 , wherein the quality of life is improved for at least 12 months.

21. The method of claim 1 , wherein the quality of life improves after 6 months of the oral immunotherapy schedule.

22. The method of claim 1 , wherein the peanut composition is administered to the patient during the maintenance phase on a daily basis.

23. The method of claim 1 , wherein the maintenance phase is at least 3 months.

24. The method of claim 1 , wherein the up-dosing phase comprises administering to the patient two or more different doses between about 3 mg and about the dose of an initial maintenance phase dose.

25. The method of claim 1 , wherein the up dosing phase is between about 3 months and about 2 years in length.

26. The method of claim 1 , wherein the oral immunotherapy schedule further comprises an initial escalation phase.

27. The method of claim 1 , wherein the patient is about 4 years old or older.

28. The method of claim 1 , wherein the patient is between about 4 years old and about 17 years old.

29. The method of claim 1 , wherein the patient is between about 8 years old and about 17 years old.

30. The method of claim 1 , wherein the method comprises measuring the quality of life before administering to the patient a peanut composition according to an oral immunotherapy schedule.

31. The method of claim 1 , wherein the method comprises measuring the quality of life after administering to the patient a peanut composition according to an oral immunotherapy schedule.

32. The method of claim 1 , wherein the quality of life of the patient is improved as determined by a quality of life questionnaire (QoLQ).

33. A method of improving the quality of life of a patient with a peanut allergy, as assessed by a quality of life questionnaire (QoLQ), the method comprising administering to the patient a peanut composition according to an oral immunotherapy schedule comprising an up-dosing phase and a maintenance phase; wherein the peanut composition is administered to the patient during the maintenance phase of the oral immunotherapy schedule at a dose of about 300 mg peanut protein.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 8, 2021
From: AIMMUNE THERAPEUTICS, INC.
To: SOCIÉTÉ DES PRODUITS NESTLÉ S.A.
Reel/Frame 058339/0592 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 3, 2021
From: BIRCHWOOD, CHRISTINE
To: AIMMUNE THERAPEUTICS, INC.
Reel/Frame 055137/0301 →
Continuity (4)
Provisional Application 62967948 · Jan 30, 2020
Provisional Application 62855384 · May 31, 2019
Provisional Application 62846481 · May 10, 2019
Related Publication 20200368304A1 · Nov 26, 2020
Cited By (2)
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