Table 1B.
Study Characteristics (Observational Studies)
| Author Journal/Conference Year | Design | Patient | Size | Study Duration | Intervention(s) | Disease Duration Definitions for Evaluating Early Biologic Use | |
|---|---|---|---|---|---|---|---|
| Rubin, Inflamm Bowel Dis., 201236 | Observational | Adult | 3750 | 2 yrs | ‘Step-Up’, IS-to-TNF’, ‘Early-TNF’ | ≤30 days | |
| Loftus, Inflamm Bowel Dis., 201945 | Observational study | Adult | 1980 | 1 year | ADA | <2 yrs, 2–<5 yrs 5–<10 yrs, ≥10 yrs | |
| Ogata, J Crohns Colitis., 201622 | Observational | Adult | 1693 | 24 wks | ADA | <2, 2 to 5, 5–10, 10–20, >20 yrs | |
| † | Kerur, CGH 201855 | Observational | Paediatric | 1442 | 10 yrs | Anti-TNFs | <3 months |
| Kugathasan, Lancet., 201749 | Observational | Paediatric | 913 | 3 yrs | IFX, ADA, IM | Newly diagnosed | |
| Faleck, CGH, 201923 | Observational | Adult | 650 | 6 months | VDZ | ≤2 yrs, >2–≤5 yr, >5 yrs | |
| Walters, Gastroenterology., 201447 | Observational | Paediatric | 552 | 1 year | Anti-TNF or IM (not specified) | Newly diagnosed | |
| Safroneeva, Aliment Pharmacol Ther., 201533 | Observational | Adult | 540 | 15 mon | IM and/or TNF antagonists | <2 yrs | |
| Oh, PLoS One., 201737 | Observational | Adult | 507 | NR | Anti-TNF or IM | <2 yrs | |
| Safroneeva, ECCO, 201334 | Observational | Adult | 450 | 15 mon | IM or Anti-TNF | <2 yrs (adjusted for diagnostic delay) | |
| Seitz, UEG 201831 | Retrospective chart review | Adult | 242 | 2 years | Anti-TNFs | <2 and >2 years | |
| Church, Inflamm Bowel Dis., 201457 | Observational | Paediatric | 195 | 8 yrs | IFX | Median 1.6 (0.6–3.0) yrs | |
| Ma, Inflamm Bowel Dis., 201638 | Observational | Adult | 190 | 154 wks§ | IFX, ADA | <2 yrs | |
| Kotze, Digestion., 201542 | Observational | Adult | 175 | NR | ADA, IFX | <2 yrs | |
| Chambrun, ECCO, 201540 | Observational | Adult‡ | 153 | 44 mon (mean) | IFX | < 18 mon | |
| Yu, Mediators Inflamm., 201526 | Observational | Adult and Paediatric | 106 | 10 wks | IFX | 22.2 mon (remission group) | |
| Wauters, Inflamm Bowel Dis., 201761 | Observational | Paediatric | 91 | 5 yrs | Anti-TNF (not specified) | 0.2 (0.1–0.5) yrs | |
| Panchal, DDS 201944 | Retrospective chart review | Adult and Paediatric | 88 | NR | Anti-TNFs w/o IM | < 2, 3–10, 11–20, 21–30 and >30 yrs | |
| Nuij, J Crohns Colitis., 201541 | Observational | Adult and Paediatric | 85 | 41.4 mon§ | IFX, IFX+ADA, ADA | Newly diagnosed, <16 mon | |
| † | Bolia, J Pediatr Gastroenterol Nutr., 201756 | Observational | Paediatric | 73 | 1 year | IFX w/o IM in early versus non-early CD | Time interval between diagnosis and introduction of IFX (mon): Loss of response group: 28 (4–90); No loss of response group: 12.5 (1–121) |
| Lee, J Pediatr Gastroenterol Nutr., 201553 | Observational | Paediatric | 51 | 3 yrs | AZA+IFX (top-down) versus step-up | 10.8 ± 9.0 (step-up) mon vs 1.0 ± 0.5 (top-down) mon | |
| † | Kato, Gut Liver., 201146 | Observational | Adult | 43 | 14 wks | IFX | 3.26±5.63 mon |
| Ling, DDS, 201860 | Retrospective chart review | Paediatric | 43 | 48 months | IFX | <3 months and ≥ 3 months | |
| † | Nuti, J Crohns Colitis., 201548 | Observational | Paediatric | 37 | 2 yrs | IFX, ADA | 13 ± 16 (0.5–63) mon |
| † | Olbjørn, Scand J Gastroenterol., 201428 | Observational | Paediatric | 36 | 2 yrs | IFX | Newly diagnosed |
| Lee, World J Gastroenterol., 201054 | Observational | Paediatric | 36 | 2 yrs | AZA+IFX, AZA | Newly diagnosed | |
| Kim, Acta Paediatr., 201150 | Observational | Paediatric | 29 | 1 year | AZA+IFX (top-down) vs step-up | Step-up: 11.5 ± 7.4; Top-down: 0.8 ± 0.6 | |
| Lee, Pediatr Gastroenterol Hepatol Nutr., 201252 | Observational | Paediatric | 28 | 3 yrs | AZA+IFX (top-down) versus step-up | Duration from the initial diagnosis to IFX infusion: Step-up: 49.6±5.2; Top-down: 1.8±2.4 wks | |
| † | Wewer, J Pediatr Gastroenterol Nutr., 200659 | Observational | Paediatric | 24 | 3 yrs | IFX (episodic) | 26 (range 0.7–93) mon |
| Lionetti, Aliment Pharmacol Ther., 200358 | Observational | Paediatric | 22 | 18 wks | IFX | <1 year | |
| Echarri, DDW 201135 | Observational | Adult | 13 | 6 mon | ADA, IFX | <2 yrs | |
| Beilman, CGH, 201862 | Model | Adult | N/A | Lifetime | ADA, IFX | <2 yrs |
ADA: adalimumab, IFX: infliximab; PBO: placebo; AZA: azathioprine; CER: certolizumab; IM: immunomodulators; IS: immunosuppressants NR: Not reported, VDZ: vedolizumab.
Studies marked
†
were not comparative studies
‡
Assumed to be adult
§
Median follow up.
Note: Nuij 2015 had 66 Crohn’s disease [CD], 16 ulcerative colitis [UC], 3 inflammatory bowel disease unclassified [IBDU]) patients, NR is not reported