Granted Patent
B2
US 12,669,498 · App. 19/426,699 · Granted Jun 30, 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:
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 (28)
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 weeks 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.
2 . The method of claim 1 , wherein the PEGylated uricase protein is administered at a dose from 8 to 12 mg.
3 . The method of claim 2 , wherein the PEGylated uricase protein is administered at a dose of 8 mg.
4 . The method of claim 2 , wherein the PEGylated uricase protein is administered at a dose of 12 mg.
5 . The method of claim 1 , wherein the PEGylated uricase protein is administered for up to 24 weeks.
6 . The method of claim 1 , wherein the PEGylated uricase protein is a mammalian uricase.
7 . The method of claim 1 , wherein the PEGylated uricase protein is pegloticase.
8 . The method of claim 1 , wherein the serum uric acid level is measured 1 week after each administration of the PEGylated uricase protein.
9 . The method of claim 1 , wherein the serum uric acid level is measured 2 weeks after each administration of the PEGylated uricase protein.
10 . The method of claim 1 , wherein the serum uric acid level is measured 3 weeks after each administration of the PEGylated uricase protein.
11 . The method of claim 1 , wherein the conventional therapy is allopurinol therapy.
12 . The method of claim 1 , wherein the patient is administered fexofenadine and hydrocortisone before each administration of the PEGylated uricase protein.
13 . A method of lowering the risk of infusion reactions while treating chronic gout refractory to conventional therapy in a patient, the method comprising:
a. intravenously administering to the patient pegloticase every 2 weeks or 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 lowering the risk of an infusion reaction.
14 . The method of claim 13 , wherein pegloticase is administered at a dose from 8 to 12 mg.
15 . The method of claim 13 , wherein the pegloticase is administered at a dose of 8 mg.
16 . The method of claim 13 , wherein the pegloticase is administered at a dose of 12 mg.
17 . The method of claim 13 , wherein the pegloticase is administered for up to 24 weeks.
18 . The method of claim 13 , wherein the serum uric acid level is measured 1 week after each administration of pegloticase.
19 . The method of claim 13 , wherein the serum uric acid level is measured 2 weeks after each administration of pegloticase.
20 . The method of claim 13 , wherein the serum uric acid level is measured 3 weeks after each administration of pegloticase.
21 . The method of claim 13 , wherein the conventional therapy is allopurinol therapy.
22 . The method of claim 13 , wherein the patient is administered fexofenadine and hydrocortisone before each administration of pegloticase.
Continuity (14)
Continuation
13379704
Provisional Application
61298718
· Jan 27, 2010
Provisional Application
61248698
· Oct 5, 2009
Provisional Application
61269669
· Jun 25, 2009
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