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. 2021 Aug 31;13(9):1368. doi: 10.3390/pharmaceutics13091368

Table 1.

Overview of published pharmacokinetic models for infliximab in patients with IBD.

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.