Table 1.
Publication | CD/UC | Patient Cohort | No. of Patients (Samples) | Sampling Times | Base Model | Covariates on CL | Covariates on Vc | IOV | Induction/ Maintenance 1 |
Inclusion of ADA+ Patients |
Ref. |
---|---|---|---|---|---|---|---|---|---|---|---|
Ternant et al., 2008 | both | adults | 33 (478) | peak, trough | 2-CMT | ADA | sex, weight | - | both | yes (15%) | [44] |
Fasanmade et al., 2009 * | UC | adults | 482 (4145) | peak, midpoint, trough | 2-CMT | ADA, alb, sex | sex, weight | - | both | yes (7%) | [23] |
Fasanmade et al., 2011 (a) * | CD | adults | 580 (/) | peak, midpoint, trough | 2-CMT | ADA, alb, IMM, weight | weight 2 | CL | both | yes (11%) | [24] |
Fasanmade et al., 2011 (c) | CD | children | 112 (/) | peak, midpoint, trough | 2-CMT | alb, weight | weight 2 | CL | both | yes (3%) | [24] |
Fasanmade et al., 2011(a/c) * | CD | both | 692 (5757) | peak, midpoint, trough | 2-CMT | ADA, alb, IMM, weight | weight 2 | CL | both | yes (10%) | [24] |
Xu et al., 2012 * | both | both | 655 3 (/) | / | 2-CMT | ADA, alb, weight 4 | weight 2 | - | / | yes (/) | [57] |
Dotan et al., 2014 | both | adults | 54 (169) | trough | 2-CMT | ADA, alb, weight 4 | weight 2 | - | both | yes (31%) | [45] |
Aubourg et al., 2015 * | CD | adults | 133 (/) | trough, peak | 2-CMT | sex | sex, weight | - | treatment initiation | no | [53] |
Buurman et al., 2015 * | both | adults | 42 (188) | trough | 2-CMT | ADA, period 5, sex | HBI | - | both | yes (5%) | [54] |
Ternant et al., 2015 | CD | adults | 111 (546) | throughout dosing interval | 1-CMT | FCGR3A-158V/V, hsCRP | - | - | maintenance | yes (2%) | [46] |
Brandse et al., 2016 * | UC | adults | 19 (/) | throughout dosing interval | 2-CMT | ADA, alb | - | - | induction | yes (32%) | [55] |
Passot et al., 2016 * | both | both | 79 6 (/) | trough | 1-CMT | CD/UC, sex, weight | CD/UC, sex, weight | - | both | no | [56] |
Brandse et al., 2017 | both | adults | 332 (997) | throughout dosing interval | 2-CMT | ADA, alb, previous exposure, weight 4 | weight 2 | - | both | yes (23%) | [47] |
Edlund et al., 2017(I–III) *,7 | CD | adults | 68 (152) | midpoint, trough | 2-CMT | ADA 8, weight 4,9 | weight 2,9 | - | maintenance | yes (37%) | [43] |
Kevans et al., 2018 | both | adults | 51 (/) | throughout dosing interval | 2-CMT | ADA, alb, weight 4, time-varying CL 10 | weight 2 | - | induction | yes (11%) | [48] |
Petitcollin et al., 2018 * | CD | children | 20 (145) | trough | 1-CMT | alb, time-varying CL/risk of immunization 11 | - | - | both | yes (15%) | [25] |
Dreesen et al., 2019 | UC | adults | 204 (583) | trough | 1-CMT | alb, CRP, Mayo | FFM, CS, panc. | CL | induction | yes (1%) 12 | [49] |
Matsuoka et al., 2019 | CD | adults | 121 (832) | trough | 1-CMT | ADA, alb, weight | - | - | maintenance | yes (26%) | [50] |
Petitcollin et al., 2019 | both | adults | 91 (607) | trough | 1-CMT | CD/UC, CRP, dose, Mayo, AZA, time-varying CL/risk of immunization 11, weight 13 | - | - | maintenance | yes (1%) | [51] |
Bauman et al., 2020 | both | children | 135 (289) | trough | 2-CMT | ADA 14, alb, ESR, weight | weight 2 | - | maintenance | yes (62%) | [21] |
Dreesen et al., 2020 | CD | adults | 116 (1329) | midpoint, trough | 2-CMT | ADA, alb, CDAI, fCal | - | - | both | yes (18%) | [27] |
Grišić et al., 2020 | both | pregnant | 19 (172) | throughout dosing interval | 1-CMT | ADA, 2nd/3rd trimester | - | - | both | yes (30%) 12,15 | [52] |
Kantasiripitak et al., 2021 | both | adults | 104 (272) | trough | 2-CMT | ADA, age, alb, CRP, FFM | - | - | induction | yes (13%) | [26] |
Note: -: none; /: unknown; (a): (adults); (a/c): (adults/children); ADA: anti-drug antibodies; ADA+: anti-drug antibody positive; alb: albumin concentrations; AZA: azathioprine; (c): children; CD: Crohn’s disease; CDAI: Crohn’s disease activity index; CL: clearance; CMT: compartment; CRP: C-reactive protein; CS: corticosteroids; ESR: erythrocyte sedimentation rate; fCal: fecal calprotectin; FCGR3A-158V/V: Fc fragment of IgG, low affinity IIIa, receptor (CD16a) polymorphism; FFM: fat-free mass; HBI: Harvey–Bradshaw index; hsCRP: high-sensitivity C-reactive protein; IBD: inflammatory bowel disease; IMM: immunomodulators; IOV: inter-occasion variability; Mayo: Mayo score; No.: number; panc.: pancolitis; Ref.: reference; UC: ulcerative colitis; Vc: volume of central compartment; * included in the external model performance evaluation; 1 blood sample data collected during induction and/or maintenance therapy; 2 covariate also on volume of peripheral compartment (Vp); 3 133 more pediatric patients with other inflammatory diseases were included; 4 covariate also on intercompartmental clearance (Q); 5 induction or maintenance phase; 6 139 more patients with other inflammatory diseases were included; 7 three similar models with different handling of the ADA covariate; 8 ADA as binary or continuous covariate; 9 allometric scaling; 10 a component of CL that varies over time independent of patient factors; 11 describing varying infliximab CL over time (independent from ADA testing); 12 percentage of ADA-positive blood samples; 13 as a covariate on the CL increase over time; 14 ADA was included as an ordinal covariate with four categories; 15 samples with infliximab concentrations ≤5 µg/mL were assessed for ADAs.