IP Library Granted Patent US 9,377,454
Granted Patent B2
US 9,377,454 · App. 13/379,704 · Granted Jun 28, 2016

Methods and kits for predicting infusion reaction risk and antibody-mediated loss of response by monitoring serum uric acid during pegylated uricase therapy

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Quick Facts
Patent No.
US 9,377,454
App. No.
13/379,704
Granted
Jun 28, 2016
Kind
B2
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 (9)

1. A method of treating a patient suffering from gout having a serum uric acid (SUA) level of 6 mg/dl or less, and reducing the incidence of infusion reaction in said patient, the method comprising:

administering to said patient, a PEGylated uricase at a dosage of 8 mg every two weeks;

after a first period of time, determining the SUA level of said patient, and

if said SUA level of the patient is maintained below 6 mg/dl, continuing said administration of PEGylated uricase at a dosage of 8 mg every two weeks, whereas if said SUA level of the patient is above 6 mg/dl, discontinuing said administration thereby reducing the incidence of infusion reaction in said patient, wherein said patient previously received ineffective allopurinol therapy or has a medical history in which allopurinol therapy is contraindicated.

2. The method according to claim 1 , wherein said SUA level is determined after 24 hours but within 2 weeks of said administering.

3. The method according to claim 1 , wherein said first period of time is two weeks.

4. The method according to claim 1 , wherein said gout is refractory.

5. The method according to claim 1 , wherein said gout is chronic or tophaceous.

6. The method according to claim 1 , wherein said PEGylated uricase is administered intravenously.

Assignments (14)
RELEASE OF SECURITY INTEREST Recorded Oct 6, 2023
From: CITIBANK, N.A.
To: HORIZON THERAPEUTICS USA, INC.
Reel/Frame 065178/0965 →
CORRECTIVE ASSIGNMENT TO CORRECT THE SELLER'S NAME AND EXECUTION DATE PREVIOUSLY RECORDED ON REEL 032675 FRAME 0936. ASSIGNOR(S) HEREBY CONFIRMS THE SELLER'S NAME SHOULD READ SAVIENT PHARMA HOLDINGS, INC. AND THE EXECUTION DATE FOR BOTH PARTIES SHOULD READ 01/09/2014. Recorded Jun 16, 2023
From: SAVIENT PHARMACEUTICALS, INC.; SAVIENT PHARMA HOLDINGS, INC.
To: CREALTA PHARMACEUTICALS LLC
Reel/Frame 064009/0261 →
CORRECTIVE ASSIGNMENT TO CORRECT THE NAME OF THE ASSIGNEE PREVIOUSLY RECORDED ON REEL 061805 FRAME 0076. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Dec 1, 2022
From: HORIZON PHARMA RHEUMATOLOGY LLC
To: HORIZON THERAPEUTICS USA, INC.
Reel/Frame 062073/0930 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 31, 2022
From: HORIZON PHARMA RHEUMATOLOGY LLC
To: HORIZON THERAPEUTICS USA, INC
Reel/Frame 061805/0076 →
CHANGE OF NAME Recorded Nov 18, 2016
From: CREALTA PHARMACEUTICALS LLC
To: HORIZON PHARMA USA RHEUMATOLOGY LLC
Reel/Frame 040648/0361 →
CHANGE OF NAME Recorded Nov 18, 2016
From: HORIZON PHARMA USA RHEUMATOLOGY LLC
To: HORIZON PHARMA RHEUMATOLOGY LLC
Reel/Frame 040648/0367 →
PATENT SECURITY AGREEMENT Recorded Sep 16, 2016
From: HORIZON PHARMA RHEUMATOLOGY LLC (FORMERLY KNOWN AS CREALTA PHARMACEUTICALS LLC)
To: CITIBANK, N.A., AS COLLATERAL AGENT
Reel/Frame 040059/0007 →
RELEASE OF SECURITY INTEREST Recorded Jan 13, 2016
From: FIFTH STREET FINANCE CORP., AS COLLATERAL AGENT
To: CREALTA PHARMACEUTICALS LLC
Reel/Frame 037483/0049 →
RELEASE OF SECURITY INTEREST Recorded Jan 13, 2016
From: JEFFERIES FINANCE LLC, AS COLLATERAL AGENT
To: CREALTA PHARMACEUTICALS LLC
Reel/Frame 037483/0148 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 15, 2014
From: SAVIENT PHARMACEUTICALS, INC.; SAVIENT PHARMA HOLDINGS, LLC
To: CREALTA PHARMACEUTICALS LLC
Reel/Frame 032675/0936 →
SECURITY AGREEMENT Recorded Feb 21, 2014
From: CREALTA PHARMACEUTICALS LLC
To: JEFFERIES FINANCE LLC, AS COLLATERAL AGENT
Reel/Frame 032319/0077 →
CORRECTIVE ASSIGNMENT TO CORRECT THE RECEIVING PARTY PREVIOUSLY RECORDED ON REEL 028363 FRAME 0040. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY AGREEMENT. Recorded Jul 23, 2013
From: SAVIENT PHARMACEUTICALS, INC.
To: U.S. NATIONAL BANK ASSOCIATION, AS COLLATERAL AGENT
Reel/Frame 030936/0072 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 3, 2012
From: ROSARIO-JANSEN, THERESA; WRIGHT, DAVID ERICK
To: SAVIENT PHARMACEUTICALS, INC.
Reel/Frame 028715/0585 →
SECURITY AGREEMENT Recorded Jun 12, 2012
From: SAVIENT PHARMACEUTICALS, INC.
To: MORGAN STANLEY SENIOR FUNDING INC.
Reel/Frame 028363/0040 →