Adverse side-effects associated with administration of an anti-hyaluronan agent and methods for ameliorating or preventing the side-effects
First Claim
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1. A method for ameliorating in a human subject an adverse musculoskeletal effect from an administered hyaluronidase, comprising:
- a) systemically administering a hyaluronidase to the subject, wherein;
the hyaluronidase is a PEGylated soluble human PH20 hyaluronidase; and
the adverse musculoskeletal effect is more severe than Grade 1, and is up to and including Grade 4;
the grade of the adverse musculoskeletal effect is defined by Common Terminology Criteria for Adverse Events (CTCAE) scale; and
b) administering a sufficient amount of a glucocorticoid to the subject to ameliorate the adverse musculoskeletal effect.
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Abstract
Provided herein are methods for ameliorating an adverse effect of systemic administration of a PEG hyaluronan degrading enzyme to a subject. The methods involve systemically administering a PEGylated hyaluronan degrading enzyme, particularly a PEGylated hyaluronidase, such as any of the animal or bacterial hyaluronidases, to the subject and administering an amount of a corticosteroid sufficient to ameliorate the adverse effect. Also provided are method of treating a hyaluronan-associated disease or condition for single-agent therapy or combination therapy.
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Citations
35 Claims
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1. A method for ameliorating in a human subject an adverse musculoskeletal effect from an administered hyaluronidase, comprising:
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a) systemically administering a hyaluronidase to the subject, wherein; the hyaluronidase is a PEGylated soluble human PH20 hyaluronidase; and the adverse musculoskeletal effect is more severe than Grade 1, and is up to and including Grade 4; the grade of the adverse musculoskeletal effect is defined by Common Terminology Criteria for Adverse Events (CTCAE) scale; and b) administering a sufficient amount of a glucocorticoid to the subject to ameliorate the adverse musculoskeletal effect. - View Dependent Claims (3, 4, 5, 6, 8, 10, 11, 12, 13, 15, 16, 17, 18, 20, 23, 24, 25, 27, 28, 30, 31, 32)
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2. A method for ameliorating an adverse musculoskeletal effect in a human subject from an administered hyaluronidase, comprising:
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a) prior to administering the hyaluronidase, administering a sufficient amount of a glucocorticoid to the subject to ameliorate an adverse musculoskeletal effect of the hyaluronidase when it is administered, wherein; the adverse musculoskeletal effect is more severe than Grade 1, and is up to and including Grade 4; and the grade of the adverse musculoskeletal effect is defined by Common Terminology Criteria for Adverse Events (CTCAE) scale; and
thenb) systemically administering the hyaluronidase, wherein; the hyaluronidase is a PEGylated soluble human PH20 hyaluronidase. - View Dependent Claims (7, 9, 29, 33)
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14. A method of ameliorating in a human subject an adverse musculoskeletal effect from a systemically administered hyaluronidase,
wherein: -
the hyaluronidase that had been administered is a PEGylated soluble human PH20 hyaluronidase; the adverse musculoskeletal effect is more severe than Grade 1, and is up to and including Grade 4; the grade of the adverse musculoskeletal effect is defined by Common Terminology Criteria for Adverse Events (CTCAE) scale; and the method comprises administering a sufficient amount of a glucocorticoid to the subject to ameliorate the adverse musculoskeletal effect. - View Dependent Claims (34)
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19. A method of ameliorating an adverse musculoskeletal effect in a subject treated for cancer with a treatment comprising administration of a hyaluronidase,
wherein: -
the hyaluronidase is a PEGylated soluble human PH20 hyaluronidase that was systemically administered for treatment of cancer; the subject is human; the adverse musculoskeletal effect is more severe than Grade 1, and is up to and including Grade 4; the grade of the adverse musculoskeletal effect is defined by Common Terminology Criteria for Adverse Events (CTCAE) scale; and the method comprises administering a sufficient amount of a glucocorticoid to the subject to ameliorate the adverse musculoskeletal effect. - View Dependent Claims (21, 22, 26, 35)
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Specification