Outcomes and Assessments
Graves’ Ophthalmopathy, diplopia, proptosis, inflammatory bowel disease
DIPLOPIA, INFLAMMATORY BOWEL DISEASE, ADVERSE EVENTS, HYPERGLYCEMIA, HEARING IMPAIRMENT, PROPTOSIS, INFUSION REACTION
The primary outcome was the change of proptosis measurements (mm) in the study eye from baseline at Week 24. Other outcomes, all at Week 24, were proptosis responder rate (percentage of patients with ≥ 2 mm reduction from baseline in the study eye without deterioration [≥ 2 mm increase] in the fellow eye), change from baseline in the Graves’ Ophthalmopathy Quality of Life (GO-QOL) questionnaire appearance and visual functioning subscales, change from baseline in diplopia as ordinal response categories, binocular diplopia responder rate (percentage of patients with baseline diplopia >0 who had reduction ≥ 1 grade, using the Bahn-Gorman scale), complete binocular diplopia responder rate (percentage of patients with baseline diplopia > 0 and score of 0 at Week 24). Change from baseline at Week 24 in diplopia as ordinal response categories was based on all randomized patients in the trial. Patients with/without diplopia at baseline were assessed for improvement (by 1 grade), significant improvement (2 or 3 grades), no change, worsening (1 grade) or significant worsening (2 or 3 grades) at Week 24. A schedule of assessments is provided (Supplemental Table S3 (Safety assessments included vital signs, adverse events (AE) and AE of special interest (AESI, infusion reactions, hyperglycemia, hearing impairment, new onset inflammatory bowel disease and exacerbation of inflammatory bowel disease). Hematology, fasting chemistry, thyroid function tests and HbA1c tests were conducted during study visits by a central laboratory (Supplemental Table S3 (