Table 1.
Adalimumab concentration thresholds during maintenance therapy associated with endoscopic outcomes in inflammatory bowel disease.
IBD type |
No. | Threshold [μg/ml] | Endoscopic outcome | Definition of mucosal healing | SN | SP | PPV | NPV | Assay | Ref. |
---|---|---|---|---|---|---|---|---|---|---|
CD | 60 | ≥ 8.14a | Mucosal healing | Absence of any ulceration in all ileocolonic segments | 91 | 76 | 84 | 86 | HMSA | [4] |
CD / UC |
66 [CD: 59] |
≥ 7.5b | Mucosal healing | Lack of any inflammation in the intestinal mucosa [erosions, ulcers, granularity, or friability] | 62 | 83 | NR | NR | HMSA | [5] |
CD / UC |
67 [CD: 58] |
> 7.1 | Mucosal healing | CD: SES-CD < 3 UC: endoscopic Mayo score < 2 or absence of any sign of inflammation both for CD and UC |
32 | 85 | 51 | 72 | ELISAc | [6] |
CD / UC |
40 [CD: 22] |
< 4.9 | Absence of mucosal healing | CD: disappearance of all ulcerations on all ileocolonic segments UC: endoscopic Mayo score < 2 |
66 | 85 | 88 | 51 | ELISAd | [7] |
IBD, inflammatory bowel disease; CD, Crohn’s disease; UC, ulcerative colitis; No., number of patients; ELISA, enzyme-linked immunosorbent assay; HMSA, homogeneous mobility shift assay; SN, sensitivity; SP, specificity; PPV, positive predictive value; NPV, negative predictive value; Ref., reference; NR, not reported; SES-CD, simple endoscopic score for CD.
aBased on serum samples collected at intervals of 1-6 days before drug administration date, for patients who received adalimumab every other week or up to 48h before the drugs were administered, for patients who received adalimumab every week.
bBased on randomly collected serum samples [as opposed to trough serum samples].
cAnti-human lambda chain detection ELISA.
dLisa-Tracker Premium ELISA kit [Theradiag, Marne la valée, France].