Table 3.
Time course of anti‐GH antibodies in the mITT population
| Total N = 81 | |
|---|---|
| Patients positive for ADA at baseline, n (%) | 0 |
| Patients negative for ADA at baseline, n (%) | 80 (98.8) |
| Patients with missing ADA at baseline, n (%) | 1 (1.2) |
| Patients with postbaseline ADA results, n (%) | 81 (100) |
| Patients positive for ADAs after initiating study medication, n (%) a | 3 (3.7) |
| 95% CI, % | 0.8–10.4 |
| Patients with positive titers by visit, n (%) b | |
| At baseline, n = 80 | 0 |
| Month 1, n = 80 | 0 |
| Month 3, n = 78 | 0 |
| Month 6, n = 79 | 1 (1.3) |
| Month 9, n = 79 | 2 (2.5) |
| Month 12, n = 75 | 2 (2.7) |
| Median time to onset of ADA, months c | 8.6 |
ADA, antidrug antibody; CI, confidence interval; GH, growth hormone; mITT, modified intent‐to‐treat.
a
Percentage based on number of patients with postbaseline ADA assay result. Positive titer if titer ≥ 1.0. Unevaluable patients were excluded from the mITT population.
b
Positive titer if titer ≥ 1.0. Percentages based on n.
c
Median time (in months) between the first dose of study treatment and first instance of ADA in all patients with treatment‐induced ADA.