Table 1.
Summary of the characteristics of the included studies.
| Study | Authors, Year | Country | Study Design | Drug Studied | Study Population (n, m/f, Age) | Study Duration | Measure of Outcomes | Intervention | CHEERS (n, %) |
|---|---|---|---|---|---|---|---|---|---|
| ST1 | Yao et al., 2021 [36] | US | Modeling approach | Adalimumab | 20,000 simulated CD pediatric biologic-naïve patients | 3 years and 4 weeks | Costs Cost savings QALY ICER |
Proactive TDM (n = 10,000) vs. Reactive TDM (n = 10,000) |
21 (87.5%) Excellent |
| ST2 | Negoescu et al., 2020 [37] | US | Modeling approach | Infliximab | 100,000 CD simulated patients | 5 years | Costs Cost savings QALY ICER |
Proactive TDM (n = NA) vs. Reactive TDM (n = NA) vs. Empirical strategy (n = NA) |
19 (79.2%) Very good |
| ST3 | Attar et al., 2019 [38] | France | Modeling approach | Infliximab | 40,000 CD simulated adult patients | 2 years | Costs Cost savings |
Proactive TDM (n = 20,000) vs. Empirical strategy (n = 20,000) |
7 (29.2%) Insufficient |
| ST4 | Freeman et al., 2016 [39] | UK | Modeling approach | Infliximab | Simulations of CD patients in maintenance treatment of infliximab | 10 years | Costs Cost savings QALY ICER |
Proactive TDM (n = NA) vs. Empirical strategy (n = NA) |
23 (95.8%) Excellent |
| ST5 | Roblin et al., 2015 [40] | France | Modeling approach | Infliximab | 10,000 Simulations of CD patients with LOR to infliximab | 1, 3 and 5 years | Cost savings | Reactive TDM (n = NA) vs. Empirical strategy (n = NA) |
10 (41.7%) Insufficient |
| ST6 | Velayos et al., 2013 [41] | US | Modeling approach | Infliximab | 10,000 simulations of CD patients with LOR to infliximab | 1 year | Costs Cost savings QALY ICER |
Reactive TDM (n = NA) vs. Empirical strategy (n = NA) |
17 (70.8%) Very good |
| ST7 | Wu et al., 2021 [42] | Australia | Prospective observational study | Infliximab | 428 IBD patients (322/296, 36 ± 18.7 yo) | 56 weeks | Cost savings | Proactive TDM (n = 181) vs. Reactive TDM (n = 247) |
12 (50.0%) Insufficient |
| ST8 | Ganesnanthan et al., 2020 [43] | UK | Retrospective observational study | Infliximab | 85 IBD patients (54/31, 39.13 ± 14.25 yo) | NA | Cost savings | Proactive TDM (n = NA) vs. Reactive TDM (n = NA) vs. Proactive TDM post-induction (n = NA) |
7 (29.2%) Insufficient |
| ST9 | Guidi et al., 2018 [44] | Italy | Prospective observational study | Infliximab | 148 IBD patients in treatment for at least 4 months with LOR to infliximab (75/73, 40.8 (37.05–42.5) yo) | 12 weeks | Costs Cost savings |
Reactive TDM (n = 96) vs. Empirical strategy (n = 52) |
17 (70.8%) Very good |
| ST10 | Taks et al., 2017 [45] | The Netherlands | Non-randomized clinical trial | Infliximab | 33 IBD adult patients (20/13, 43 (32–59) yo) | 1 year | Cost savings | Proactive TDM (n = 28) vs. Reactive TDM (n = 33) |
4 (16.7%) Insufficient |
| ST11 | Vande Castelee et al., 2015 [46] | Belgium | Randomized controlled clinical trial | Infliximab | 251 IBD adult patients with a stable clinical response for at least 14 weeks (138/113, 41 (34.5–49.0) yo) | 2 years and 16 weeks | Costs Cost savings QALY ICER |
Proactive TDM (n = 128) vs. Empirical strategy (123) |
18 (75.0%) Very good |
| ST12 | Steenholdt et al., 2015 [47] | Denmark | Randomized controlled clinical trial | Infliximab | 69 CD adult patients with LOR to infliximab (27/69, 37 (19–81) yo) | 20 and 52 weeks | Costs Cost savings |
Reactive TDM (n = 33) vs. Empirical strategy (n = 36) |
17 (70.8%) Very good |
| ST13 | Steenholdt et al., 2014 [48] | 12 weeks | 17 (70.8%) Very good |
M: male; f: female; CHEERS: Consolidated Health Economic Evaluation Reporting Standards; CD: Crohn’s disease; QALY: quality-adjusted life-years; ICER: incremental cost-effectiveness ratio; IBD: inflammatory bowel disease; yo: years old; NA: not available; LOR: loss of response.