26 Nov Novel Biologic for Active Thyroid Eye Disease
MedicalResearch.com Interview with:
Raymond S. Douglas, MD, PhD
Cedars-Sinai, Los Angeles
MedicalResearch.com: What is the background for this study?
Response: The data presented at the American College of Rheumatology (ACR) annual meeting on November 11, 2019 are integrated, pooled efficacy data from the Phase 2 and Phase 3 clinical trials of teprotumumab for the treatment of active thyroid eye disease (TED) compared to placebo. The results support prior analyses of significant reductions in inflammation, proptosis (eye bulging) and diplopia (double vision), as well as improvements in quality of life (QoL). This presentation of the pooled analyses builds on the individual positive results of the Phase 2 and Phase 3 clinical studies.
MedicalResearch.com: What are the main findings?
Specific data show:
- Proptosis (eye bulging): 77.4% of patients receiving teprotumumab experienced a ≥2mm reduction in proptosis, compared to 14.9% of patients receiving placebo (p<.0001).
- Diplopia (double vision): The diplopia responder rate, which is defined as the percentage of patients whose diplopia improved 1 or more grades, was higher with teprotumumab (69.7%) versus placebo (30.5%; p<0.001) in those with baseline diplopia.
- Quality of Life (QoL): Patients treated with teprotumumab experienced improvements in average change from baseline through week 24 in QoL scores (overall 15.55 vs 5.92, p<0.001), including visual functioning (16.81 vs 6.10, p<0.001) and appearance (13.51 vs 5.78, p=0.002).
MedicalResearch.com: What should readers take away from your report?
Response: This is the largest placebo-controlled evaluation of active thyroid eye disease (TED) to date – demonstrating significant improvements in the areas that matter most to patients, including proptosis (eye bulging), diplopia (double vision) and quality of life. These data build upon the individual positive results of the Phase 2 and Phase 3 clinical studies – providing further evidence of the potential for teprotumumab to reduce the painful and disfiguring symptoms of TED.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: There is an open-label extension study that is currently ongoing called OPTIC-X. The OPTIC-X trial is designed to better understand whether certain patients may benefit from retreatment or longer treatment (more than six months) with teprotumumab. OPTIC-X is a 48-week, open-label extension study in which patients who participated in the OPTIC Phase 3 clinical trial may receive up to eight additional infusions of teprotumumab. The primary endpoint is proptosis responder rate (the percentage of participants with ≥2 mm reduction in proptosis in the study eye) without deterioration (≥2 mm increase) of proptosis in the fellow eye.
MedicalResearch.com: Is there anything else you would like to add?
Response: Thyroid eye disease (TED) is a debilitating disease – affecting people functionally, psychologically and economically, including the inability to work and perform daily activities. The pain, vision impairment, depression and loss of self confidence caused by TED have a substantial effect on patients’ well-being.
There is a significant need for new medicines to treat active thyroid eye disease (TED). Current treatment options focus only on managing inflammation and symptomatic relief, and do not address the biology of the disease. If approved, teprotumumab would be the first FDA approved medicine for active TED.
Disclosure: Consultant Horizon, 2019
Kahaly G, Sile S, Thompson E, Vescio T, Perdok R, Sherman J, Smith T, Douglas R. Teprotumumab, a Novel Biologic for Active Thyroid Eye Disease [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/teprotumumab-a-novel-biologic-for-active-thyroid-eye-disease/.
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