Table I.
Summary of the Effect of Immunogenicity on Pharmacokinetics and Efficacy for 31 Products; Data Grouped by the Effect on Pharmacokinetics (↑ = increase, ↔ = no change, ↓ = decrease)
ADA type | CL | Number of products | Percent of total number of drugs | Efficacy | Number of products |
---|---|---|---|---|---|
Clearing | ↑ | 13 | 42.0 | ↓ | 8 |
NRa | 5 | ||||
No effect | ↔ | 10 | 32.2 | ↔ | 6 |
NR | 4 | ||||
Sustaining | ↓ | 6 | 19.4 | ↓ | 1 |
↔ | 1 | ||||
NR | 4 | ||||
Inconclusive | Unknown | 2 | 6.4 | NR | 2 |
Total number of drugs | 31 | 100 | 31 |
a NR not reported, including about equal number of products with no mention in the labeling or labeling mentioned a conclusion could not be drawn based on limited available data