Table 2.
Generic TDM algorithm for biopharmaceutical therapies of patients with inflammatory diseases
| Measurements | Decision support | ||
|---|---|---|---|
|
| |||
| Exposure | Response | ||
|
| |||
| Drug concentration at trough | ADA concentration at trough | Responder (proactive TDM) | Nonresponder (reactive TDM) |
| Above target (range) | NA | Taper treatment | Switch to another drug class |
| Within target (range) | NA | Maintain same dosing regimen | Switch to another drug class |
| Below target (range) | Undetectablea | Consider treatment intensification/maintaining/stopb | Intensify treatment |
| Detectablea | Consider treatment stop | Consider treatment intensification or switchc | |
| Undetectable | Undetectabled | Consider treatment intensification/stopb | Intensify treatment |
| Detectabled | Consider treatment stop | Consider switchc | |
Notes: TDM algorithms typically provide decision support based on the measurement of drug and ADA concentrations.
Use a drug-tolerant ADA assay.
The clinical evidence for different decision support options may vary between drugs/indications.
Switch within drug class or to another drug class.
Use a drug-sensitive ADA assay. Always check for patient compliance in case of self-administered biopharmaceuticals, especially when drug concentrations are below the target (range). Change in dosage regimen is under responsibility of the treating clinician and it is necessary to assess for clinical response and drug concentration thereafter.
Abbreviations: ADA, antidrug antibody; NA, not applicable; TDM, therapeutic drug monitoring.