Table 2

Concentrations of CZP (μg/mL) in breast milk after administration of CZP dose in mothers

Mother numberRelative time (days)
0246810121428
17BLQBLQBLQBLQBLQBLQBLQBLQBLQ
4BLQBLQBLQBLQBLQBLQBLQBLQ
13BLQBLQBLQBLQBLQBLQBLQBLQ
14BLQBLQBLQBLQBLQBLQBLQBLQ
7BLQBLQBLQBLQBLQ0.035BLQBLQ
6BLQBLQ0.0440.048BLQBLQBLQBLQ
8BLQBLQ0.0350.0340.043BLQBLQBLQ
10BLQBLQBLQ0.0330.0420.042BLQBLQ
12BLQBLQ0.0340.0370.033BLQBLQBLQ
2BLQBLQ0.0350.0370.041BLQ0.043BLQ
11BLQBLQ0.0510.0380.042BLQ0.033BLQ
15BLQBLQ0.0410.0340.033BLQ0.037BLQ
160.0400.0330.0360.0370.043BLQBLQBLQ
3BLQ0.0320.0490.0530.0370.0370.0330.033
90.0390.0400.0470.0450.0420.0430.0380.035
10.0570.0510.0660.0650.0620.0560.0520.041
50.0560.0690.0740.0760.0760.0690.0690.060
  • White coloured areas depict CZP concentration Less than 3×LLOQ (<0.096 μg/mL).

  • Grey coloured areas depict CZP concentration Less than 2×LLOQ (<0.064 μg/mL).

  • Dark grey coloured areas depict CZP concentration BLQ (<0.032 μg/mL).

  • Days 0 and 14 are predose for mothers on the CZP 200 mg Q2W dosing regimen.

  • Days 0 and 28 are predose for the mother on the CZP 400 mg Q4W dosing regimen.

  • For reference, the mean 12-week CZP plasma Ctrough value, that is, the trough concentration at steady-state, reported from non-pregnant patients with RA receiving CZP 200 mg Q2W in the RAPID2 trial was 15.7 µg/mL (95% CI 14.0 to 17.7).28

  • BLQ, below the lower limit of quantification, <0.032 µg/mL; CZP, certolizumab pegol; LLOQ, lower limit of quantification; Q2W, every 2 weeks; Q4W, every 4 weeks; RA, rheumatoid arthritis.