Tepezza data from the phase II clinical trial evaluates longer-term responses in people living with thyroid eye disease (TED).- Horizon Therapeutics

Horizon Therapeutics plc announced new long-term follow-up data from the Phase II clinical trial of Tepezza (teprotumumab-trbw), which showed a sustained response up to one year following completion of treatment for Thyroid Eye Disease (TED). These data will be presented as part of the Academy of Managed Care Pharmacy (AMCP) Nexus 2020 Virtual Meeting. Tepezza is the first and only medicine approved by the FDA for the treatment of TED – a serious, progressive and vision-threatening rare autoimmune disease. In the Phase II and Phase III clinical trials, Tepezza demonstrated clinically significant improvements in several key indicators of TED, including proptosis (eye bulging), diplopia (double vision) and clinical activity score (CAS), at Week 24. To understand the long-term benefits of Tepezza, patients from the Phase II clinical trial were followed for 51 weeks (study Week 72) after their last infusion of Tepezza. Study findings only include patients who had Week 72 data (n=37). The study assessed the percent of patients who received Tepezza and had any improvement in proptosis, diplopia or CAS, as well as the percent with disease inactivation, as measured by a CAS of 0 or 1 point at the end of the study. Four patients received non-Tepezza therapy (corticosteroids and/or orbital decompression surgery) during this follow-up period and were counted as improved in the study. Key findings include the following : All patients with Week 72 data (37/37) reported some improvement in at least one of the study outcomes from baseline. 97 percent (36/37) had an improvement in CAS (decrease of at least 1 point). 86 percent (31/36) had any decrease in proptosis. One patient chose elective TED surgery at Week 70 and did not have proptosis measurements at Week 72. Of patients with baseline diplopia, 70 percent (23/33) had an improvement of at least one grade. 70 percent (26/37) had disease inactivation (CAS of 0 or 1 point). This study adds to the body of evidence supporting the long-term effects of Tepezza, including data recently announced from the Phase III OPTIC 48-week off-treatment follow-up period. In that analysis, the majority of Tepezza patients who were proptosis responders at Week 24 in OPTIC maintained their response at Week 72 (19/34; 56 percent) without receiving additional TED treatment. Of the 15 patients who did not qualify as maintaining a proptosis response, eight patients were at least 2 mm better than baseline at the time of their last assessment in the OPTIC 48-week off-treatment follow-up period. There were no new safety concerns in the OPTIC 48-week off-treatment follow-up period. Additional data from the OPTIC trial will be presented at future medical congresses.