Granted Patent
B2
US 12,188,927 · App. 18/630,584 · Granted Jan 7, 2025
Methods and kits for predicting infusion reaction risk and antibody-mediated loss of response by monitoring serum uric acid during PEGylated uricase therapy
Assignee:
Horizon Therapeutics USA, Inc.
G01N33/5308A61K9/0019A61K38/44A61K47/60A61P19/02C12Y107/03003G01N33/6893G01N2333/90694G01N2800/107G01N2800/52G01N2800/56
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Abstract
Methods and kits for predicting infusion reaction risk and antibody-mediated loss of response during intravenous PEGylated uricase therapy in gout patients is provided. Routine SUA monitoring can be used to identify patients receiving PEGylated uricase who may no longer benefit from treatment and who are at greater risk for infusion reactions.
Claims (23)
1. A method of minimizing the risk of an infusion reaction while treating chronic gout refractory to conventional therapy in a patient, the method comprising:
a. intravenously administering to the patient a therapeutically effective amount of a PEGylated uricase protein every 4 weeks;
b. measuring the serum uric acid level of the patient after each said administration; and
c. either continuing to administer the PEGylated uricase protein if the patient's serum uric acid is measured to be less than 6 mg/dl, or discontinuing administration of the PEGylated uricase protein if the patient's serum uric acid level is measured to be at least 6 mg/dl, thereby minimizing the risk of an infusion reaction.
2. The method of claim 1 , wherein the PEGylated uricase protein is administered at a dose from 8 to 12 mg every 4 weeks.
3. The method of claim 2 , wherein the PEGylated uricase protein is administered at a dose of 8 mg every 4 weeks.
4. The method of claim 2 , wherein the PEGylated uricase protein is administered at a dose of 12 mg every 4 weeks.
5. The method of claim 1 , wherein the PEGylated uricase protein is pegloticase.
6. The method of claim 1 , wherein the serum uric acid level is measured 1 week after each administration of the PEGylated uricase protein.
7. The method of claim 1 , wherein the serum uric acid level is measured 2 weeks after each administration of the PEGylated uricase protein.
8. The method of claim 1 , wherein the serum uric acid level is measured 3 weeks after each administration of the PEGylated uricase protein.
9. The method of claim 1 , wherein the conventional therapy is allopurinol therapy.
10. The method of claim 1 , wherein the patient is administered fexofenadine and hydrocortisone before each administration of the PEGylated uricase protein.
11. A method of minimizing infusion reactions while treating chronic gout refractory to conventional therapy in a patient, the method comprising:
a. intravenously administering to the patient a therapeutically effective amount of a pegloticase every 4 weeks;
b. measuring the serum uric acid level of the patient after each said administration; and
c. either continuing to administer pegloticase if the patient's serum uric acid is measured to be less than 6 mg/dl, or discontinuing administration of pegloticase if the patient's serum uric acid level is measured to be at least 6 mg/dl, thereby minimizing the risk of an infusion reaction.
12. The method of claim 11 , wherein pegloticase is administered at a dose from 8 to 12 mg every 4 weeks.
13. The method of claim 11 , wherein the serum uric acid level is measured 1 week after each administration of pegloticase.
14. The method of claim 11 , wherein the serum uric acid level is measured 2 weeks after each administration of pegloticase.
15. The method of claim 11 , wherein the serum uric acid level is measured 3 weeks after each administration of pegloticase.
16. The method of claim 11 , wherein the conventional therapy is allopurinol therapy.
17. The method of claim 11 , wherein the patient is administered fexofenadine and hydrocortisone before each administration of pegloticase.
Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 16, 2024
From: ROSARIO-JANSEN, THERESA; WRIGHT, DAVID ERICK
To: SAVIENT PHARMACEUTICALS, INC.
Reel/Frame 067118/0062 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 16, 2024
From: SAVIENT PHARMACEUTICALS, INC.
To: CREALTA PHARMACEUTICALS LLC
Reel/Frame 067125/0144 →
CHANGE OF NAME
Recorded Apr 16, 2024
From: CREALTA PHARMACEUTICALS LLC
To: HORIZON PHARMA RHEUMATOLOGY LLC
Reel/Frame 067125/0168 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 16, 2024
From: HORIZON PHARMA RHEUMATOLOGY LLC
To: HORIZON THERAPEUTICS USA, INC.
Reel/Frame 067125/0650 →
Continuity (11)
Continuation
13379704
Provisional Application
61298718
· Jan 27, 2010
Provisional Application
61248698
· Oct 5, 2009
Provisional Application
61269669
· Jun 25, 2009
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