Fourth-Quarter and Full-Year 2019 Orphan and Rheumatology Segment Results
Phase 3 Trial: 82.9 Percent of Patients Achieved Primary Endpoint of Proptosis Response
Proptosis Response (Reduction of ≥2 mm) at Week 24
100
Proptosis Responders (%)
40
60
80
20
20
56.1
p<0.001
82.9
82.9
75.6
p<0.001
p<0.001
p<0.001
Difference: 73.45
(95%CI 58.89, 88.01)
14.3
14.3
9.5
7.1
0
Baseline
Week 6
Week 12
Week 18
Week 24
TEPEZZA (N=41)
Placebo (N=42)
Proptosis Reduction of 3.32 mm at Week 24(1)
Proptosis Reduction (mm)
0
-0.38
-0.64
-0.59
-0.53
2
3
-2.00
-2.70
Difference: -2.79
(95%CI -3.40, -2.17)
-3.26
-3.32
-4
Week 0
Week 6
Week 12
Week 18
Week 24
TEPEZZA (N=41)
Placebo (N=42)
Note: Throughout the 24-week treatment period, patients treated with TEPEZZA had an average proptosis reduction of 2.82 mm compared with 0.54 mm for those who received placebo (p<0.001).
(1) Change from baseline in proptosis as a continuous variable is based on Mixed-Model Repeated-Measures (MMRM) analysis of covariance (ANCOVA) model with an unstructured covariance matrix including the following terms: baseline score,
tobacco use status (non-user, user), treatment group, visit, and visit-by-treatment and visit-by-baseline-score interactions.
HORIZON
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