Table 3.
Pharmacokinetic parameters of the sarilumab pen and syringe
| Parametera | Sarilumab q2w + DMARDs | |||
|---|---|---|---|---|
| Pen 150 mg | Syringe 150 mg | Pen 200 mg | Syringe 200 mg | |
| C max, mg/L | ||||
| Week 0–2, n | 53 | 51 | 50 | 53 |
| Mean (SD) | 16.5 (9.2) | 16.7 (13.0) | 27.6 (15.2) | 23.7 (12.7) |
| Week 10–12, n | 45 | 44 | 36 | 46 |
| Mean (SD) | 21.7 (12.9) | 24.2 (14.8) | 50.4 (33.8) | 39.4 (22.3) |
| t max, days | ||||
| Week 0–2, n | 53 | 51 | 50 | 53 |
| Median (range) | 2.9 (1.8–11.0) | 2.9 (0.9–6.9) | 3.9 (1.9–10.0) | 3.7 (1.7–10.9) |
| Week 10–12, n | 45 | 44 | 36 | 46 |
| Median (range) | 3.9 (0.0-6.8) | 3.1 (1.7-7.0) | 3.9 (1.0-8.0) | 3.9 (1.0-11.0) |
| AUC0–τ, mg day/L | ||||
| Week 0–2, n | 39 | 34 | 34 | 41 |
| Mean (SD) | 131 (54.5) | 152 (76.7) | 235 (117) | 227 (94.9) |
| Week 10–12, n | 44 | 40 | 36 | 38 |
| Mean (SD) | 205 (126) | 220 (130) | 455 (294) | 405 (244) |
AUC 0–τ area under the plasma concentration–time curve from 0 to the end of the dosing period, C max maximum observed drug concentration, DMARD disease-modifying antirheumatic drug, q2w every 2 weeks, SD standard deviation, t max time to C max
aData were excluded if a patient did not take the study drug or took the wrong dose at day 1 or 71