Table 4:
A comparison of the incidence of AEs in the RCTs with AEs in this study.
| Our Data | Clinical Trial Data: Teprotumumab-Relateda,b | |||
|---|---|---|---|---|
| Adverse Event | Affected Patients | Percent | Affected Patients | Percent |
| Any AE | 107 | 82% | 47 | 56% |
| Muscle Spasm | 76 | 58% | 16 | 19% |
| Fatigue | 36 | 27% | 3 | 4% |
| Diarrhea | 36 | 27% | 7 | 8% |
| Alopecia | 35 | 27% | 8 | 10% |
| Nausea | 18 | 14% | 8 | 10% |
| None | 24 | 18% | 37 | 44% |
| Hearing Change | 40 | 31% | 4 | 5% |
| Headache | 15 | 11% | 5 | 6% |
| Menstrual | 14 | 11% | 4 | 10%c |
| Dysgeusia | 11 | 8% | 4 | 5% |
| Hyperglycemia | 14 | 11% | 7 | 8% |
| Skin Rash | 10 | 8% | 3 | 4% |
| Dry Skin | 11 | 8% | 4 | 5% |
| Onychoclasis | 10 | 8% | 4 | 5% |
| AEs resulting in discontinuation of treatmentd | 16 | 12.2% | 3 | 4% |
a
Probably or possibly related to teprotumumab as assessed by investigator.
b
Source: Kahaly et. Al. Teprotumumab for patients with active thyroid eye disease: a pooled data analysis, subgroup analyses, and off-treatment follow-up results from two randomised, double-masked, placebo-controlled, multicentre trials. Lancet Diabetes Endocrinol. 2021.
c
Only reported in Phase II clinical trial, 4/42 patients with reproductive AEs
d
Hearing impairment, IBD, hyperglycemia, and severe muscle cramps and nausea led to discontinuation in our study cohort. IBD, infusion reaction, and Hashimoto’s encephalopathy led to discontinuation in the clinical trials.