Study Population
diplopia, TED, strabismus, hyperthyroidism, euthyroid, proptosis, Crohn's disease, hypothyroidism, optic neuropathy
DIPLOPIA, INFLAMMATORY BOWEL DISEASE, ULCERATIVE COLITIS, DISEASE, STRABISMUS, OPTIC NERVE, HYPERTHYROIDISM, COLOR VISION DEFECTS, SECONDARY, REMISSION, PROPTOSIS, CROHN'S DISEASE, HYPOTHYROIDISM, OPTIC NEUROPATHY
Key inclusion criteria were age ≥18 years, with a TED diagnosis of at least 2 years but < 10 years before screening and a diagnosis of stable, chronic (inactive) TED. Stable/inactive disease was defined as a CAS ≤ 1 in both eyes prior to screening for at least 1 year or all of the following for at least 1 year before screening: no proptosis progression, no diplopia progression in patients with history of diplopia, and no new inflammatory TED symptoms. Patients must have had ≥ 3-mm increase in proptosis from before diagnosis of TED and/or proptosis ≥ 3 mm above normal values for race and sex. Patients were required not to be pregnant, and to be euthyroid although mild (free thyroxine and triiodothyronine levels <50% +/− normal limits) hypothyroidism or hyperthyroidism was allowed at screening. Hemoglobin A1C (Hb1Ac) levels were required to be ≤ 8% at baseline, and those with a history of inflammatory bowel disease, ulcerative colitis, or Crohn's disease must have been in remission for ≥ 3 months with no bowel surgery in the 6 preceding months.Key exclusion criteria were previous strabismus surgery, orbital radiation, or orbital decompression in the study eye, decreasing visual acuity due to optic neuropathy or a visual field or color vision defect secondary to optic nerve involvement in the previous 6 months, any glucocorticoid use within 3 weeks before screening, rituximab use in the previous 12 months, tocilizumab use in the previous 6 months, any nonsteroid immunosuppressive agent in the previous 3 months before infusion, or any monoclonal antibody in the 3 previous months before screening, or any previous treatment with teprotumumab. A complete list of inclusion and exclusion criteria is provided in Supplemental Table S1 (