Methods for the treatment of thyroid eye disease
AssigneeHorizon Therapeutics Ireland DAC
InventorsJeffrey W. SHERMAN, Dennis A. BENNETT, Srini RAMANATHAN, Yan XIN, Elizabeth THOMPSON, Elizabeth O'NEILL
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Abstract
Provided herein are methods of treating or reducing the severity of thyroid eye disease (TED), also known as thyroid-associated ophthalmopathy (TAO), or Graves' ophthalmopathy or orbitopathy (GO), as well as antibodies, or antigen binding fragments thereof, and pharmaceutical compositions comprising them, useful in the methods.
Claims25
1-91. (canceled)
A method of treating a subject with moderate-to-severe inactive/chronic thyroid eye disease (TED) comprising administering to the subject an effective amount of an insulin-like growth factor-I receptor (IGF-1R) inhibitor to reduce proptosis in the subject, wherein the IGF-1R inhibitor is an antibody that specifically binds to IGF-1R and inhibits the binding of IGF-I and IGF-II to IGF-1R, and wherein the subject with moderate-to-severe inactive/chronic TED has the following characteristics at the time of the first administration of the IGF-1R inhibitor:
- (i) an increase of ≥3 mm proptosis relative to the subject's value prior to diagnosis of TED or an increase of ≥3 mm proptosis above the normal values for the subject's race and gender;
- and
- (ii) a clinical activity score (CAS) of 0 or 1 in both eyes for at least 1 year as determined by the seven-item scale.
A method of treating a subject with moderate-to-severe inactive/chronic TED comprising administering to the subject an effective amount of teprotumumab to reduce proptosis by at least 2 mm in the subject, wherein the subject with moderate-to-severe inactive/chronic TED has the following characteristics at the time of the first administration of the IGF-1R inhibitor:
- (i) an increase of ≥3 mm proptosis relative to the subject's value prior to diagnosis of TED or an increase of ≥3 mm proptosis above the normal values for the subject's race and gender;
- and
- (ii) a clinical activity score (CAS) of 0 or 1 in both eyes for at least 1 year as determined by the seven-item scale.
Dependencies are inferred from the claim text.