Table 1.
Biologic induction TDM thresholds and associated therapeutic outcomes for anti-TNF agents.
| IBD type | Study type and sample size | Total N | Threshold concentration [µg/mL] | Associated therapeutic outcome and time point | Reference |
|---|---|---|---|---|---|
| Infliximab | |||||
| Week 2 | |||||
| CD | Post-hoc analysis of RCT [TAILORIX] | 122 | >23.1 | Endoscopic remission at week 12 | Dreesen et al41 |
| CD | Retrospective cohort [fistulizing CD] | 36 | >9.3 | Fistula response at week 14 | Davidov et al42 |
| CD | Prospective cohort | 72 | ≥26.7 | Clinical response at week 14 | Clarkston et al33 |
| CD | Prospective cohorta | 184 | >20.4 | Clinical remission at week 14 | Gonczi et al35 |
| CD | Prospective cohorta | 184 | >16.9 | Clinical response at week 14 | Gonczi et al35 |
| UC | Prospective cohorta | 107 | >15.3 | Clinical remission at week 14 | Gonczi et al35 |
| UC | Prospective cohorta | 107 | >11.5 | Clinical response at week 14 | Gonczi et al35 |
| UC | Post hoc analysis of RCT [JAPIC] | 82 | >21.3 | Clinical remission at week 14 | Kobayashi et al36 |
| UC | Post-hoc analysis of two RCTs [ACT 1 and 2] | 484 | ≥18.6 | Mayo endoscopic score <2 at week 8 | Vande Casteele et al40 |
| UC | Retrospective cohort | 101 | ≥28.3 | Mucosal healing at weeks 10–14 | Papamichael et al15 |
| CD/UC | Retrospective case-control | 140 | <6.8 | Primary non-response at week 14 | Bar-Yoseph et al29 |
| Week 6 | |||||
| CD | Post-hoc analysis of RCT [TAILORIX] | 122 | > 10 | Endoscopic remission at week 12 | Dreesen et al41 |
| CD | Retrospective cohort [fistulizing CD] | 36 | > 7.3 | Fistula response at week 14 | Davidov et al42 |
| CD | Prospective cohort | 72 | ≥15.9 | Clinical response at week 14 | Clarkston et al33 |
| UC | Post-hoc analysis of two RCTs [ACT 1 and 2] | 484 | ≥10.6 | Mayo endoscopic score <2 at week 8 | Vande Casteele et al40 |
| UC | Post-hoc analysis of two RCTs [ACT 1 and 2] | 728 | >22 | Clinical response at week 8 | Adedokun et al22 |
| UC | Prospective cohort | 19 | > 6.6 | Endoscopic response at week 8 | Brandse et al37 |
| UC | Retrospective cohort | 101 | ≥15 | Mucosal healing at week 10–14 | Papamichael et al15 |
| Week 14 | |||||
| CD | Post-hoc analysis of RCT [ACCENT 1] | 291 | ≥3.5 | Sustained clinical response up to week 54 | Cornillie et al13 |
| CD | Prospective cohort [PANTS] | 955 | > 7.0 | Clinical remission at both week 14 and week 54 | Kennedy et al34 |
| UC | Post-hoc analysis of two RCTs [ACT 1 and 2] | 728 | > 5.1 | Clinical response at week 30 | Adedokun et al22 |
| UC | Post-hoc analysis of two RCTs [ACT 1 and 2] | 484 | ≥5.1 | Mayo endoscopic score <2 at week 8 | Vande Casteele et al40 |
| UC | Post-hoc analysis of two RCTs [ACT 1 and 2] | 484 | ≥6.7 | Mayo endoscopic score = 0 at week 8 | Vande Casteele et al40 |
| UC | Retrospective cohort | 101 | ≥2.1 | Mucosal healing at weeks 10–14 | Papamichael et al15 |
| CD/UC | Prospective cohort | 35 | >4.8 | Clinical response at week 14 | Tighe et al32 |
| Adalimumab | |||||
| Week 2 | |||||
| CD | Prospective cohort | 98 | > 6.7 | Clinical remission at week 14 | Ungar et al44 |
| Week 4 | |||||
| CD | Prospective cohort | 116 | <8.3 | AAA formation at week 12 | Verstockt et al45 |
| CD | Prospective cohort | 116 | >12 | Biological remission at week 12 | Verstockt et al45 |
| CD | Prospective cohort | 28 | > 7.3 | Clinical remission at week 12 | Vande Casteele et al55 |
| UC | Retrospective cohort | 43 | ≥7.5 | Mucosal healing at weeks 8–14 | Papamichael et al60 |
| UC | Retrospective cohort | 73 | ≥4.6 | Clinical response at week 12 | Baert et al61 |
| UC | Retrospective cohort | 73 | ≥7 | Clinical response at week 52 | Baert et al61 |
| CD/UC | Prospective cohort | 35 | >3.5 | Clinical response at week 4 | Tighe et al32 |
| Golimumab | |||||
| Week 2 | |||||
| UC | Post-hoc analysis of RCT [PURSUIT] | 1064 | > 8.9 | Clinical response at week 6 | Adedokun et al65 |
| Week 6 | |||||
| UC | Post-hoc analysis of RCT [PURSUIT] | 1064 | > 2.5 | Clinical response at week 6 | Adedokun et al65 |
| UC | Retrospective cohort | 21 | > 2.6 | Partial clinical response at week 14 | Detrez et al66 |
| Certolizumab pegol | |||||
| Week 6 | |||||
| CD | Post-hoc analysis of nine RCTs | 2157 | >31.8 | Clinical response/remission at week 6 | Vande Casteele et al71 |
| CD | Post-hoc analysis of nine RCTs | 2157 | >31.9 | CRP ≤5 mg/L at week 6 | Vande Casteele et al71 |
| CD | Post-hoc analysis of nine RCTs | 2157 | >32.7 | FC <250 mg/g at week 6 | Vande Casteele et al71 |
| CD | Post-hoc analysis of nine RCTs | 2157 | >34.5 | FC <250 mg/g and CDAI ≤150 at week 6 | Vande Casteele et al71 |
| CD | Post-hoc analysis of nine RCTs | 2157 | >36.1 | FC [<250 mg/g] and CDAI ≤150 at week 26 | Vande Casteele et al71 |
| Week 8 | |||||
| CD | Post-hoc analysis of RCT [MUSIC] | 45 | >23.3 | Endoscopic remission at week 10 | Colombel et al72 |
Abbreviations: CD, Crohn’s disease; UC, ulcerative colitis; RCT, randomized controlled trial; AAA, anti-adalimumab antibodies; FC, faecal calprotectin; CRP, C-reactive protein; CDAI, Crohn’s disease activity index.
aCT-P13.