IVIG treatments for Bell's palsy
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Publication Number
US-11083789-B2
Publication Date
2021-08-10
Expiration Date
Abstract
The present invention provides, among other aspects, methods and compositions for treating Bell's Palsy disease in a subject in need thereof, the method comprising: administering a therapeutically effective amount of a composition comprising human intravenous immunoglobulin (IVIG) to a subject. The present invention also provides, methods and composition for treating Bell's Palsy disease in a subject in need thereof, the method comprising: administering a therapeutically effective amount of a composition comprising human IVIG and a steroid. In certain aspects of the present invention the steroid is a cortical steroid, including Prednison.
Core Innovation
The invention relates to a method for treating Bell's Palsy disease in a subject in need thereof. The method comprises administering a therapeutically effective amount of a composition comprising human intravenous immunoglobulin (IVIG) to a subject, and the human IVIG is administered in a treatment context intended for Bell's Palsy.
A key aspect of the method is that the immunoglobulin is co-administered with a steroid. The steroid is described as a cortical steroid, including prednisone, and the co-administration of human IVIG with a steroid is positioned to address severity and recovery in Bell's Palsy.
The disclosed treatment includes rationale and safety/side-effect considerations associated with IVIG use, including managing infusion-rate and premedication. The disclosure further provides example regimens and outcome observations, including an example with IVIG 2 g/kg with prednisone 60 mg/day that is described as leading to approximately 70% symptom reduction within about 2 weeks, and another described scenario includes resolution approaching about 95% after a second IVIG dose.
Claims Coverage
The independent claim covers a Bell's Palsy treatment method defined by two core inventive elements: administration of a therapeutically effective amount of human IVIG and co-administration of a steroid. The dependent claims then refine the steroid identity, specify prednisone daily dosage ranges, constrain IVIG dosing amount and dosing period, and add outcome timing/extent constraints.
Human IVIG co-administered with a steroid
A method for treating Bell's Palsy in a subject in need thereof comprising administering a therapeutically effective amount of a composition comprising human intravenous immunoglobulin (IVIG) to a subject, wherein the immunoglobulin is co-administered with a steroid.
Prednisone as the steroid
The method wherein the steroid is prednisone.
Prednisone daily dosage range
The method wherein the steroid is administered as prednisone at a daily dosage between about 5 mg/day and 200 mg/day.
Therapeutically effective IVIG amount and treatment period
The method wherein the immunoglobulin is administered as a therapeutically effective amount of from about 0.1 g/kg to 10 g/kg in one or more doses over a period of two to eight weeks.
Example regimen: single IVIG dose with prednisone 60 mg/day
The method wherein the immunoglobulin is administered as a therapeutically effective single dose of about 2 g/kg and prednisone is administered at about 60 mg/day.
Bell’s Palsy resolution within two weeks
The method wherein Bell's Palsy is 50–70% resolved within two weeks.
Overall, the claim set centers on Bell's Palsy treatment by co-administering a therapeutically effective amount of human IVIG with a steroid, with refinements specifying prednisone and its daily dosage range, constraining IVIG dosing amount and dosing period, providing an example regimen, and adding an outcome constraint for resolution within two weeks.
Stated Advantages
Reduce severity and shorten recovery time compared with steroids alone.
Achieve substantial symptom reduction, including approximately 70% symptom reduction within about 2 weeks in an example.
Enable resolution approaching about 95% after a second IVIG dose in another described example.
Documented Applications
Treating Bell's Palsy in a subject in need thereof using human IVIG co-administered with a steroid.
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