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. 2016 Jun 23;2016:9248061. doi: 10.1155/2016/9248061

Table 3.

Evaluation of the potential impact of ADA on efficacy among patients with treatment-emergent ADA.

Treatment Patient ADA + time point DSN (days) ANC AUC ANC maximum ANC nadir
Phase II study

Pegfilgrastim 10 D85 Cycle 1 0 160.25 9.60 6.8
Cycle 2 0 212.95 14.90 7.9
Cycle 3 0 116.25 8.50 3.6
Cycle 4 0 91.85 7.50 2.4

Lipegfilgrastim 2 D360 Cycle 1 1 154.24 20.39 0.18
Cycle 2 1 170.20 21.40 0.0
Cycle 3 0 225.40 27.64 1.25
Cycle 4 0 202.26 28.42 1.72
1 D85 Cycle 1 0 127.80 17.00 0.8
Cycle 2 0 147.25 9.60 2.2
Cycle 3 0 121.60 8.30 0.7
Cycle 4 0 179.55 16.70 1.3

Phase III study

Pegfilgrastim 17 D85 Cycle 1 0 219.88 47.99 0.89
Cycle 2 0 198.15 13.73 2.2
Cycle 3 0 302.98 68.32 2.16
Cycle 4 0 315.63 57.42 4.06

Lipegfilgrastim 13 D360 Cycle 1 2 160.16 26.14 0.25
Cycle 2 0 257.95 51.92 1.25
Cycle 3 0 300.24 58.91 1.2
Cycle 4 0 291.36 68.75 1.45

ADA: antidrug antibody; ANC: absolute neutrophil count; AUC: area under the curve; D85: day 85; D360: day 360; DSN: duration of severe neutropenia.