Table 1.
Exposure-outcome relationship data of infliximab in pediatric IBD.
| IBD type |
Treatment time point | Threshold (μg/mL) |
Therapeutic outcome and time point | TDM assay |
Ref. |
|---|---|---|---|---|---|
| CD | Induction (w2) | >9.2 | Clinical remission (w14) | ELISA | 7 |
| CD | Induction (w2) | ≥26.7 | Clinical response (w14) | ELISA | 8 |
| CD | Induction (w6) | >2.2 | Drug retention beyond one year of treatment | ELISA | 7 |
| CD | Induction (w6) | ≥18 | CRP<0.5 mg/dL | ELISA | 8 |
| CD | Induction (w6) | ≥15.9 | Clinical response (w14) | ELISA | 8 |
| CD | Induction (w6) | >8.3 | Clinical remission (w14) | ELISA | 9 |
| CD/UC | Induction (w6) | >9.8 | CRP <0.5 mg/dL | ELISA | 10 |
| CD | Post-induction (w10) | ≥9.1 | Drug retention (w52) | HMSA | 11 |
| CD | Post-induction (w14) | >12.7 | Fistula response (w24) | ELISA | 12 |
| CD/UC | Post-induction (w14) | >5.5 | Clinical remission (w54) | HMSA | 13 |
| CD/UC | Post-induction (w14) | >2 | ESR <18 mm/hr | ELISA | 10 |
| CD/UC | Post-induction (w14) | >3.1 | Sustained clinical remission | ELISA | 14 |
| CD | Maintenance | ≥2.5 | Relapse after drug withdrawal for remission | ELISA | 15 |
| CD | Maintenance | >4.9 | Biochemical remission | ELISA | 16 |
| CD | Maintenance | >5 | Mucosal healing | ELISA | 16 |
| CD/UC | Maintenance | >5.4 | Endoscopic remission | ELISA | 17 |
| CD/UC | Maintenance | >1.6 | ESR <18 mm/hr | ELISA | 10 |
ELISA: enzyme-linked immunosorbent assay; HMSA: homogeneous mobility shift assay; CRP: C-reactive protein, FC: fecal calprotectin; TDM: therapeutic drug monitoring; CD: Crohn’s disease; UC: ulcerative colitis; Ref.: reference; w: week; hr: hour.