Benefits of Teprotumumab Consistent Across Various Ages, Genders

March 31, 2020
Patrick Campbell

Study from ENDO 2020 assesses the effects of teprotumumab based on the age, gender, and smoking status of patients.

A new study presented at the Endocrine Society (ENDO) 2020 Annual Scientific Sessions is detailing the impact of teprotumumab (Tepezza) on proptosis across a variety of different age-, gender-, and risk factor-based subgroups.

The analysis, which examines a phase 2 and phase 3 clinical trial of the insulin-like growth factor 1 receptor inhibitory monoclonal antibody, indicated teprotumumab was effective across multiple subgroups of patients across the 24-week trials.

"Teprotumumab decreases inflammation in the eye and the build-up of tissues behind the eye that produce the long-term symptoms that reduce quality of life for patients with thyroid eye disease," said lead researcher George J. Kahaly, MD, PhD, of Johannes Gutenberg University Medical Center in Mainz, Germany. "It offers thyroid eye disease patients new hope."

The first FDA-approved treatment for thyroid eye disease (TED), teprotumumab’s approval in January marked a turning point for those afflicted by the rare disease. From the pair of 24-week randomized, double-masked, placebo-controlled, parallel-group clinical trials, investigators identified a total of 171 patients with active TED associated with Graves’ disease.

The study eye was designated at baseline manifested more severe TED and a clinical score of more than 4. Investigators segmented patients into subgroups based on gender, smoking status and age at baseline. The primary outcomes of the study was the percentage of proptosis responders and proptosis change from baseline.

Investigators noted an overwhelming majority of patients in both groups were white and they were unable to assess the impact of race on response.

Of the 171 patients included, 84 were randomized to teprotumumab and 87 were randomized to placebo—baseline characteristics were balanced between the 2 groups. At the end of the 24-week studies, patients receiving teprotumumab were significantly more likely to to be proptosis responders regardless of gender (male: 73.1% vs. 5.0%, female: 79.3% vs. 17.9%), smoking status (smokers: 70.0% vs. 23.1%, non-smokers 79.7% vs. 11.5%), and age (younger: 76.1% vs. 16.2%, older: P <.001).

Results of continuous variable analyses indicated mean proptosis education from baseline was significantly greater at week 24 among patients treated with teprotumumab compared to those treated with placebo regardless of gender (male: -3.34 vs. -0.07 mm, female: -3.10 vs. -0.42 mm), smoking status (smokers: -2.99 vs. -0.72 mm, nonsmokers: -3.20 vs. -0.31 mm), and age (younger: -3.10 vs. -0.39 mm, older: -3.55 vs. -0.22 mm) (all P <.001).

This study, “Effect of Teprotumumab on Proptosis Reduction Across Various Demographic Sub-Group,” was accepted for presentation at ENDO 2020.

For more on the impact of teprotumumab on patients with TED, check out our interview with Raymond Douglas, MD, PhD, professor of ophthalmology and director of the Orbit and Thyroid Eye Disease Center at Cedars-Sinai, from ACR 2019.