Characteristics of the Study Population
autoimmune diseases, ophthalmopathy
ADVERSE EVENT, AUTOIMMUNE DISEASES, DISEASE CHARACTERISTIC, OPHTHALMOPATHY
Eighty-one patients were screened between August 12, 2021, and September 15, 2022, and 62 were randomized (42 to teprotumumab and 20 to placebo [ITT population]). Thirty-nine of 42 patients (93%) in the teprotumumab group, and 19/20 (95%) in the placebo group completed the double-masked treatment period (Enrollment, randomization, and completion of treatment period. Patients not meeting criteria at Day 1 were screening failed. Abbreviations: AE, adverse event, ITT, intention-to-treat population.Demographics and disease characteristics were predominantly balanced across groups at baseline (Demographics and disease characteristics at baselineGraves’ ophthalmopathy quality of life questionnaire (GO-QOL): range 0-100, with higher scores indicating better quality of life. Levels of thyroxine, thyrotropin, triiodothyronine, and autoimmune diseases were assessed in the safety population. Abbreviation: CAS, Clinical Activity Score.