Teprotumumab (Tepezza)
是Insulin-like gowth factor -1 (IGF-1) receptor 的人類單株抗體抑制劑
2020年1月被FDA approve用來治療TED
把IGF-1 receptor block掉可以減少發炎反應 使眼眶後組織增生回復 和眼框內 hyaluronan的製造
給法是每3周注射1次 總共8個療程
共79個病人完成phase 2 trial, 76個病人完成phase 3 trial (OPTIC trial)
Proptosis reductions >= 2mm without deterioration of the fellow eye at week 24
Intention- to -treat analysis (P<0.001)
- 77.4% with Teprotumumab
- 14.9% with placebo
Per-Protocal analysis (P<0.001)
-84.8% with Teprotumumab
-17.1 % with placebo
Number needed to treat 1.6
Similar results were achieved across all subgroups of patients: those aged 65 and older versus younger than aged 65; male versus female; tobacco user versus nonuser; and US versus EU study centers (all P < .001).
Average decrease in proptosis (P < .001)
- Teprotumumab: 3.1 mm
- Placebo 0.4 mm
實驗中沒有死亡但在teprotumumab組有7個嚴重副作用, Placebo組1個
其中
1例: 腹瀉 1例: 注射相關反應 1例:Hashimoto encephalopathy 使藥物中斷
Adverse event
- Teprotumumab 79.8%
- Placebo 69.8%
Teprotumumab組較多的包括 muscle spasms (25% vs 7%), nausea (17% vs 9%), alopecia (13% vs 8%), and diarrhea (12% vs 8%).
大部分在療程結束後會緩解
Antidrug antibodies有2位, 不常見
Reference:
Teprotumumab Eases Thyroid Eye Disease in All, Including Smokers - Medscape - Apr 22, 2020.
