Efficacy and Safety of Teprotumumab in Patients With Thyroid Eye Disease of Long Duration and Low Disease Activity
Primary result · Proptosis improvementResult — go to the resultDifference −1.48 mm 95% CI −2.28 to −0.69Authors' conclusion
Teprotumumab significantly improved proptosis vs placebo in longstanding/low inflammation TED, demonstrating efficacy regardless of disease duration/activity. The safety profile was comparable to that previously reported.
Study context
- Population
- Adults with chronic/low disease activity thyroid eye disease (TED): duration 2 to 10 years, Clinical Activity Score (CAS) ≤ 1 or no additional inflammation or progression in proptosis/diplopia for ≥1 year, proptosis ≥3 mm, euthyroid/mildly hypo/hyperthyroid, no prior teprotumumab, no steroids within 3 weeks of baseline; 11 US centersrandomized 2:1
- Participants
- 62 adults
- Comparison
- IV teprotumumab vs placebo once every 3 weeks
- Teprotumumabn = 42
- Placebon = 20reference
- Primary endpoint
- Proptosis (mm) improvement
- Follow-up
- Week 24
Methodological detailsdouble-masked, placebo-controlled, multicentre (11 US centers), randomized 2:1
- Double-masked
- Placebo-controlled
- Multicentre (11 US centers)
- Randomized 2:1
Primary result
Proptosis improvement
Difference
−1.48 mm
95% CI −2.28 to −0.69
P = 0.0004
Change by group
Teprotumumab
−2.41
least squares mean · SE 0.228 · mm
Placebo
−0.92
least squares mean · SE 0.323 · mm
Teprotumumabvs Placebo
difference −1.48 mm (95% CI −2.28 to −0.69); P = 0.0004
As reported in the abstract
Safety
Hyperglycemia
Hearing impairment
Events
| Outcome | Teprotumumab | Placebo |
|---|---|---|
| AEs leading to discontinuation | 1 | 1 |
- Adverse events (AEs) leading to discontinuation: Teprotumumab: left ear conductive hearing loss with congenital anomaly; placebo: infusion-related
AEs
- Proportions of patients with AEs were similar between groups
- No deaths
Original publication
Efficacy and Safety of Teprotumumab in Patients With Thyroid Eye Disease of Long Duration and Low Disease Activity. J Clin Endocrinol Metab. Published 31 October 2023. doi:10.
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