Abstract #1407025: Hearing-Related Adverse Events and Quality of Life Assessments in Thyroid Eye Disease Patients Treated with Teprotumumab

Abstract

Hearing-related adverse events (AEs) with insulin-like growth factor-I receptor inhibitors have been reported in clinical trials. Phase 2, phase 3 (OPTIC) and OPTIC extension (OPTIC-X) controlled clinical trials included 121 teprotumumab-treated patients. Of these patients, 20 (16.5%) reported 23 AEs coded for the Ear and Labrinth category of the Medical Dictionary for Regulatory Activities. 12 (9.9%) of these 20 patients reported 13 hearing-related events (tinnitus, hearing loss/impairment, hyper/hypoacusis, autophony, eustachian tube dysfunction) with 6 (5%) considered drug-related by the investigator. 77% of the events were considered mild with none as severe. All patients with hearing-related AEs completed the 24-week study. To evaluate the Graves’ Ophthalmopathy Quality of Life (GO-QOL) scores (0 worst-100 best) in patients reporting hearing-related AEs, we examined all 12 of these patients from 3 clinical trials with teprotumumab as compared to those without hearing-related events (N=109). Of the 12 patients reporting hearing-related AEs to teprotumumab in the clinical trials, 2 reported events in both the OPTIC and OPTIC-X studies. Baseline overall GO-QOL score was similar between the 2 groups (61 for hearing AE group versus 63). Mean overall GO-QOL scores improved consistently from baseline and were similar for patients with and without hearing impairment AEs at 6, 12, and 24 weeks (4,10,15 versus 12,14,17, respectively). At Week 24 (3 weeks after final infusion of teprotumumab), the overall GO-QOL score was 76 and 80 for those with and without hearing AEs, respectively. Each patient reporting a hearing AE improved their GO-QOL score from baseline. Of patients reporting a hearing AE in 3 clinical trials with teprotumumab, none withdrew and all reported improvement in quality of life as evidenced by increased GO-QOL scores during and at the end of the study. Mean overall GO-QOL scores improved consistently from baseline manifesting large to moderate improvement in quality of life at Week 24.