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 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;
the subject is human; and
the adverse musculoskeletal effect is selected from among;
an adverse effect that is Grade 3 or Grade 4; and
an adverse effect that is ongoing or persistent Grade 2 toxicity that fails to resolve over a course of treatment with the hyaluronidase and that limits the ability of the subject to comply with the hyaluronidase therapy;
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
68 Claims
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1. A method for ameliorating in a 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; the subject is human; and the adverse musculoskeletal effect is selected from among; an adverse effect that is Grade 3 or Grade 4; and an adverse effect that is ongoing or persistent Grade 2 toxicity that fails to resolve over a course of treatment with the hyaluronidase and that limits the ability of the subject to comply with the hyaluronidase therapy; 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, 9, 10, 11, 12, 13, 14, 15, 17, 18, 19, 20, 21, 23, 26, 27, 28, 29, 30, 31, 32, 35, 36, 37, 38, 39, 49, 50, 51, 52, 53, 54, 55, 56, 66)
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2. A method for ameliorating in a subject an adverse musculoskeletal effect 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 subject is human; the adverse musculoskeletal effect is selected from among; an adverse effect that is Grade 3 or Grade 4; and an adverse effect that is ongoing or persistent Grade 2 toxicity that fails to resolve over a course of treatment with the hyaluronidase and that limits the ability of the subject to comply with the hyaluronidase therapy; 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, 40, 41, 46, 57, 58, 59, 67)
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16. A method of ameliorating in a subject an adverse musculoskeletal effect from an administered hyaluronidase, comprising:
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a) intravenously administering the hyaluronidase, wherein; the hyaluronidase is a PEGylated soluble human PH20 hyaluronidase; the subject is human; and the adverse musculoskeletal effect is selected from among; an adverse effect that is Grade 3 or Grade 4; and an adverse effect that is ongoing or persistent Grade 2 toxicity that fails to resolve over a course of treatment with the hyaluronidase and that limits the ability of the subject to comply with the hyaluronidase therapy; 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 (42, 43, 47, 60, 61, 62)
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22. A method of ameliorating in a subject an adverse musculoskeletal effect in a subject from an administered hyaluronidase, comprising:
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a) systemically administering a hyaluronidase to the subject in an amount to treat a cancer that is a tumor, wherein; the hyaluronidase is a PEGylated soluble human PH20 hyaluronidase; the subject is human; and the adverse musculoskeletal effect is selected from among; an adverse effect that is Grade 3 or Grade 4; and an adverse effect that is ongoing or persistent Grade 2 toxicity that fails to resolve over a course of treatment with the hyaluronidase and that limits the ability of the subject to comply with the hyaluronidase therapy; 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 effect. - View Dependent Claims (24, 25, 33, 34, 44, 45, 48, 63, 64, 65, 68)
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Specification