Granted Patent
B2
US 12,560,596 · App. 19/345,445 · Granted Feb 24, 2026
Methods and kits for predicting infusion reaction risk and antibody-mediated loss of response by monitoring serum uric acid during pegylated uricase therapy
Assignee:
AMGEN 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 (32)
1 . A method of lowering 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 PEGylated uricase protein every 2 or 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 lowering the risk of an infusion reaction;
wherein the PEGylated uricase protein is selected from the group consisting of an Aspergillus flavus uricase that has been PEGylated, an Arthrobacter globiformis uricase that has been PEGylated, a Candida utilis uricase that has been PEGylated, and pegloticase; and
wherein each polyethylene glycol (PEG) molecule of the PEGylated uricase has a molecular weight between 1 kDa and 50 kDa.
2 . The method of claim 1 , wherein the PEGylated uricase protein is a Candida utilis uricase that has been PEGylated or pegloticase.
3 . The method of claim 2 , wherein each PEG molecule of the PEGylated uricase has a molecular weight between 5 kDa and 20 kDa.
4 . The method of claim 3 , wherein each PEG molecule of the PEGylated uricase has a molecular weight of between 10 kDa and 12 kDa.
5 . The method of claim 3 , wherein each PEG molecule of the PEGylated uricase has a molecular weight of about 10 kDa or about 20 kDa.
6 . The method of claim 2 , wherein the PEGylated uricase protein is pegloticase.
7 . The method of claim 2 , wherein the PEGylated uricase protein is a Candida utilis uricase that has been PEGylated.
8 . The method of claim 1 wherein the PEGylated uricase protein is an Aspergillus flavus uricase that has been PEGylated.
9 . The method of claim 1 wherein the PEGylated uricase protein is an Arthrobacter globiformis uricase that has been PEGylated.
10 . The method of claim 1 , wherein the PEGylated uricase protein is administered at a dose from 8 to 12 mg.
11 . The method of claim 1 , wherein the PEGylated uricase protein is administered for up to 24 weeks.
12 . The method of claim 1 , wherein the serum uric acid level is measured 1 week after each administration of the PEGylated uricase protein.
13 . The method of claim 2 , wherein the serum uric acid level is measured 1 week after each administration of the PEGylated uricase protein.
14 . The method of claim 5 , wherein the serum uric acid level is measured 1 week after each administration of the PEGylated uricase protein.
15 . The method of claim 1 , wherein the serum uric acid level is measured 2 weeks after each administration of the PEGylated uricase protein.
16 . The method of claim 2 , wherein the serum uric acid level is measured 2 weeks after each administration of the PEGylated uricase protein.
17 . The method of claim 5 , wherein the serum uric acid level is measured 2 weeks after each administration of the PEGylated uricase protein.
18 . The method of claim 1 , wherein the serum uric acid level is measured 3 weeks after each administration of the PEGylated uricase protein.
19 . The method of claim 2 , wherein the serum uric acid level is measured 3 weeks after each administration of the PEGylated uricase protein.
20 . The method of claim 5 , wherein the serum uric acid level is measured 3 weeks after each administration of the PEGylated uricase protein.
21 . The method of claim 1 , wherein the conventional therapy is allopurinol.
22 . The method of claim 1 , wherein the PEGylated uricase protein is administered intravenously every 2 weeks.
23 . The method of claim 1 , wherein the PEGylated uricase protein is administered intravenously every 4 weeks.
24 . The method of claim 2 , wherein the PEGylated uricase protein is administered intravenously every 2 weeks.
25 . The method of claim 2 , wherein the PEGylated uricase protein is administered intravenously every 4 weeks.
26 . The method of claim 5 , wherein the PEGylated uricase protein is administered intravenously every 2 weeks.
27 . The method of claim 5 , wherein the PEGylated uricase protein is administered intravenously every 4 weeks.
Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 5, 2025
From: ROSARIO-JANSEN, THERESA; WRIGHT, DAVID ERICK
To: SAVIENT PHARMACEUTICALS, INC.
Reel/Frame 072794/0436 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 5, 2025
From: SAVIENT PHARMACEUTICALS, INC.
To: CREALTA PHARMACEUTICALS LLC
Reel/Frame 073465/0174 →
CHANGE OF NAME
Recorded Nov 5, 2025
From: CREALTA PHARMACEUTICALS LLC
To: HORIZON PHARMA RHEUMATOLOGY LLC
Reel/Frame 073465/0241 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 5, 2025
From: HORIZON PHARMA RHEUMATOLOGY LLC
To: HORIZON THERAPEUTICS USA, INC.
Reel/Frame 073465/0721 →
Continuity (13)
Continuation
13379704
Provisional Application
61298718
· Jan 27, 2010
Provisional Application
61248698
· Oct 5, 2009
Provisional Application
61269669
· Jun 25, 2009
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