TABLE 2.
Estimate (90% confidence interval) for exposure–response model parameters (based on week 12 PASI response)
| Model parameter | PASI75 | PASI90 | PASI100 a |
|---|---|---|---|
| Placebo response at 90 kg (%) | 5.42 (3.74, 7.72) | 1.65 (0.86, 3.09) | 0.45 (0.15, 1.51) |
| Emax (%) | 62.16 (58.73, 65.41) | 37.89 (34.04, 41.73) | 14.63 (11.23, 17.93) |
| EC50 (μg mL−1) | 0.36 (0.22, 0.61) | 0.46 (0.25, 0.86) | 0.55 (0.21, 1.37) |
| Placebo response at 56 kg b (%) | 8.40 (5.84, 11.94) | 3.15 (1.67, 5.77) | 0.73 (0.24, 2.51) |
| Placebo response at 131 kg b (%) | 3.77 (2.48, 5.56) | 0.97 (0.49, 1.89) | 0.30 (0.09, 1.04) |
EC50, drug concentration needed to achieve 50% of the maximum drug effect; Emax, maximum drug effect; PASI, Psoriasis Area and Severity Index.
a
PASI100 model parameters were centred to a baseline PASI score of 18. Subjects with higher baseline PASI responses had lower PASI100 placebo responses. Note that no baseline effect was detected for PASI75 and PASI90; therefore, responses were considered valid across all baseline PASI scores and did not require centring.
b
Body weight levels (56 kg and 131 kg) represent the 5th and 95th percentiles, respectively.