Table 1.
Composite outcomes
| Author | Year | Outcome | Outcome definition | Outcome type | Reported outcomes | CS-free* | Longitudinal |
|---|---|---|---|---|---|---|---|
| Sandborn | 2020 | Clinical remission 1.5/1.0 and endoscopic remission | Average daily SF of ≤1.5 and AP score of ≤1.0, with neither worse than the baseline value, SES-CD of ≤4 and a ≥2-point decrease from baseline, with no subscore >1 | Secondary | Week: 0, 12/16, 52 | 0 | Panel |
| Clinical response and endoscopic response 25% | 30% decrease from baseline in SF and/or AP score, with neither parameter worse than patients’ baseline score; ≥25% decrease in SES-CD from baseline | Secondary | Week: 0, 12/16, 52 | 0 | Panel | ||
| Roblin | 2020 | Clinical failure | HBI ≥ 5 associated with FC > 250 µg/g OR the occurrence of adverse events requiring to stop treatment | Other predefined | Month: 0, 3, 6, 9, 12, 15, 18, 21, 24 | 0 | Kaplan–Meier |
| Time to clinical failure | See clinical failure | Other predefined | Month: 0, 3, 6, 9, 12, 15, 18, 21, 24 | 0 | Time to | ||
| Hisamatsu | 2019 | Corticosteroid-free triple remission | CDAI < 150, SES-CD ≤ 2 and CRP < 0.10 mg/dl | Other predefined | Week: 52 | 1 | Cross-sectional |
| Fukushima | 2018 | Endoscopic and/or clinical recurrence | Rutgeerts’ score i3 or i4 and/or CDAI > 150 | Primary | Month: 24 | 0 | Cross-sectional |
| Feagan | 2018 | Deep remission | CDAI < 150 and CDEIS ≤ 4 [or ≤2 for patients with isolated ileitis] | Other predefined | Week: 52 | 0 | Cross-sectional |
| d’Haens | 2018 | Sustained corticosteroid-free clinical remission | CDAI < 150 from week 22 to 54 and no ulcers at week 54 and no surgery for bowel resection or abscess and no new fistula and complete withdrawal of glucocorticosteroïds | Primary | Week: 54 | 1 | Sustained |
| Colombel | 2017 | Deep remission | CDAI < 150, CDEIS < 4 and no deep ulcers, absence of draining fistula, discontinuation of corticosteroids for ≥8 weeks | Secondary | Week: 48 | 1 | Cross-sectional |
| Biological remission | FC < 250 μg/g, CRP < 5 mg/L, and CDEIS < 4 | Secondary | Week: 48 | 0 | Cross-sectional | ||
| Regueiro | 2016 | Clinical recurrence | CDAI > 200 and a ≥70-point increase from baseline, and Rutgeerts’ score ≥i2 or fistula/abscess development or treatment failure [i.e. initiated prohibited CD medication, had prohibited use of CD medication, or had CD-related surgery] | Primary | Week: 76 | 0 | Cross-sectional |
| Clinical recurrence | See primary outcome | Secondary | Week: 104 | 0 | Cross-sectional | ||
| Endoscopic recurrence | Rutgeerts’ score ≥i2 or fistula/abscess development or treatment failure [i.e. initiated prohibited CD medication, had prohibited use of CD medication, or had CD-related surgery] | Secondary | Week: 76 | 0 | Cross-sectional | ||
| vande Casteele | 2015 | Clinical and biochemical remission | HBI ≤ 4 and CRP ≤ 5 mg/L | Primary | Year: 1 | 0 | Cross-sectional |
| Durable remission | HBI ≤ 4 and CRP ≤ 5 mg/L throughout the entire randomized maintenance phase | Secondary | Until year 1 | 0 | Durable | ||
| Savarino | 2013 | Endoscopic and clinical recurrence | Rutgeerts’ score i2, i3 or i4; score of 2 on the clinical recurrence grading scale proposed by Hanauer et al; CDAI > 200 | Primary | Year: 2 | 0 | Cross-sectional |
| Yoshida | 2012 | Clinical remission | CDAI ≤ 150, IOIBD score < 2, and CRP < 0.3 mg/dL | Primary | Month: 12 | 0 | Cross-sectional |
| Clinical remission | CDAI ≤ 150, IOIBD score < 2, and CRP < 0.3 mg/dL | Secondary | Month: 36 | 0 | Cross-sectional |
*Corticosteroid use taken into account. 0: no data available on corticosteroid use during efficacy evaluations; 1: corticosteroid-free status use is part of outcome definition of efficacy evaluation; 2: corticosteroid use is reported during evaluation.