Study: Significant QOL improvements for patients with TED
In a recent study that evaluated the compassionate use of teprotumumab demonstrated large quality of life (QOL) improvements. The results and safety findings were similar to those in previous controlled clinical trials, according to a study presented at ARVO 2021.
The study evaluated the safety profile and Graves’ ophthalmopathy quality of life questionnaire (GO-QOL) for teprotumumab for a group of patients in which compassionate use was deemed appropriate, prior to the drug’s January 2020 FDA approval to treat thyroid eye disease (TED). Participants included adults with active, moderate-to-severe TED who received 8 infusions (10 mg/kg first infusion, 20 mg/kg thereafter) of teprotumumab over 21 weeks. Adverse events (AEs), lab assessments, vitals and GO-QOL (max QOL=100) were assessed.
Twenty-two patients (7.2 months TED duration) from 8 sites were treated. Eighty-six percent (19 of 22) received 8 infusions (3 discontinued treatment). Baseline Total GO-QOL was 47.8±21.4. At Week 21, Total GO-QOL improved from baseline by 24.9±21.0 points. All patients reported an AE, including 1 patient with unrelated appendicitis. Other AEs included muscle spasms, fatigue, hypoacusis, headache, nausea, extremity pain, alopecia, hypertension, dry skin, diarrhea, tinnitus, myalgia, increased lacrimation, and hypogeusia. No new safety concerns were identified.
Douglas RS, et al. Teprotumumab use in a real-world setting: expanded access program findings. Presented at: ARVO 2021.