Granted Patent B2

US 12,496,331 · App. 16/347,900 · Granted Dec 16, 2025

Inventors: Jeffrey D. Kent (Deerfield, IL); Brian Lamoreaux (Lake Forest, IL)

Assignee: Horizon Therapeutics USA, Inc.

A61K38/443A61K9/0019A61K31/381A61K31/519A61K31/573A61P37/00C12Y107/03003

Abstract

Claims (21)

1 . A method of reducing uric acid levels in a subject in need thereof, comprising:

repeatedly administering to the subject both pegloticase and methylprednisolone during a treatment period, wherein the methylprednisolone is administered as a pre-dose prophylaxis prior to each administration of pegloticase;

wherein 8 mg of pegloticase and 40 to 120 mg of methylprednisolone are administered once every 14 days during the treatment period;

wherein pegloticase is administered for at least 12 doses during the treatment period;

wherein no serum uric acid lowering therapeutic besides pegloticase is administered during the course of administering pegloticase; and

wherein a second non-uricase urate-lowering therapy is administered after discontinuing the administration of pegloticase at the end of the treatment period.

2 . The method of claim 1 , wherein the second non-uricase urate-lowering therapy is an oral urate-lowering agent (ULA) selected from a xanthine oxidase inhibitor, allopurinol, and febuxostat.

3 . The method of claim 1 , wherein the serum uric acid levels are reduced to ≤6 mg/dL as a result of treatment with pegloticase.

4 . The method of claim 1 , wherein the subject was previously treated with one or more of an oral urate-lowering therapy, a xanthine oxidase inhibitor, allopurinol, and febuxostat; or wherein the subject has a body weight ≥ about 80 kg, 90 kg, 100 kg, 110 kg, or 120 kg; or wherein the subject is ≥55, 60, 65, or 70 years old.

5 . The method of claim 1 ,

wherein the method includes ameliorating or reducing at least one symptom or measurable physiological parameter of hyperuricemia or gout in the subject;

wherein the method includes reducing the subject's uric acid levels, reducing incidence of gout flares, reducing inflammation of the joints, reducing formation of gout tophi, reducing gout arthritis, and/or reducing uric acid nephropathy;

wherein the method includes reducing the subject's C-reactive protein levels;

wherein the method includes reducing the subject's Health Assessment Questionnaire Disability Index (HAQ-DI);

wherein the method includes ameliorating or reducing gout, chronic gout, refractory gout, or tophaceous gout;

wherein the method includes delaying or preventing an infusion reaction in the subject;

wherein the method includes decreasing immune clearance of the uricase molecule or reducing or preventing an antibody response to the uricase molecule in the subject; or

wherein the method increases immunosuppression or antigen-specific immunosuppression.

6 . The method of claim 1 ,

wherein pegloticase and methylprednisolone are administered by intravenous infusion.

7 . The method of claim 1 , wherein the methylprednisolone is administered 10 days, 9 days, 8 days, 7 days, 6 days, 5 days, 4 days, 4 days, 3 days, 2 days, 1 day, 18 hours, 12 hours, 6 hours, 4 hours, 2 hours, or 1 hour prior to the administration of the uricase molecule.

Assignments (2)

Continuity (2)

References Cited (400)