Table 2.
Study characteristics—baseline data and definition of outcomes.
| Male (%) | Age (in years) | Baseline CRP/FCa | Indication for combination therapy | Clinical effectiveness definitions | Endoscopy effectiveness definitions | EIM assessment | |
|---|---|---|---|---|---|---|---|
| Sands et al7 | 24 (46) | m 39.9 (±12·6) | CRP: m 6.5 mg/L (±11.1) | Active luminal disease | Response: 70-point decrease from baseline in the CDAI score Remission: CDAI <150 |
NR | NR |
| Buer et al28 | 5 (50) | c (R 22–48) | CRP: 5.45 mg/dL (R 0.6 to 52.4) | Active luminal disease | Remission: HBI ≤4 or pMS ≤1 |
Response: CD, significant improvement but still with ulceration; UC, decrease in endoscopic Mayo >1 Remission: CD, absence of ulcerations; UC, Mayo <1 |
NR |
| Mao et al29 | 3 (75) | NR | CRP: 37.4 mg/L (27.2 to 41.0) | Active luminal disease; extraluminal disease | NR | NR | NR |
| Dolinger et al32b | 8 (50%) | M 15.9 (IQR 13.5–16.9) |
CRP: 5.7 mg/L (1.5 to 23) | Active luminal disease | Remission: CD: wPCDAI ≤12.5; UC/IBD-U: pMS <2 | NR | NR |
| Fumery et al33 | 4 (57.1) | M 49 (IQR 31–53) |
NR | Active luminal disease; extraluminal disease; paradoxical adverse event | NR | NR | NR |
| Glassner et al10 | 16 (32) | m 36.7 (±13·2) |
CRP: 5 mg/dL (1.34 to 23.4) | Active luminal disease; extraluminal disease | Remission: HBI < 5, partial Mayo < 3 | Remission: SES-CD score 0–2, Rutgeerts score i0–i1, or Mayo score 0 | NR |
| Kwapisz et al9 | 5 (33.3) | M 36 | NR | Active luminal disease | Response: CD: PRO UC: partial Mayo score |
NR | NR |
| Olbjorn et al34b | 6 (46) | M 16 (R 11–17.5) |
NR | Active luminal disease; extraluminal disease; paradoxical adverse event | NR | NR | Improvement in psoriasis |
| Privitera et al35 | 7 (44) | M 38 (R 27–69) |
NR | Active luminal disease; extraluminal disease | NR | NR | EIM clinical activity was classified as severe, mild, or remission according to clinical judgment |
| Yang et al11 | 10 (45) | M 35 (IQR 31–43) |
CRP: 17 mg/L (11.0 to 24.0) | Active luminal disease | Response: PRO-2 reduction by 8 Remission: PRO-2 <8 |
Response: >50% reduction in SES-CD or explicitly stated in endo report Remission: SES-CD<3 |
NR |
| Alayo et al30 | 17 (49) | M 32 (IQR 26–39) |
CRP: 1.35 mg/dL (0.5 to 11.6) | Active luminal disease | Response: >50% reduction in symptoms assessed based on PGA Remission: 100% reduction in symptoms assessed based on PGA |
Response: CD: >50% reduction in SES-CD or ≥50% reduction in MaRIAs UC: ≥1 grade reduction in Mayo Remission: CD: SES-CD of 0–2 or Global MaRIAs score of < 6; UC: Mayo subscore of 0 or 1 |
NR |
| Lee et al31 | 9 (47) | M 40 (IQR 30–50) |
CRP: 3.7 mg/dL (1·7 to14·9) | Active luminal disease; extraluminal disease | Response: ≥3 point decrease in HBI Remission: HBI ≤4 |
Response: ≥50% decrease in SES-CD Remission: SES-CD ≤3 Healing: SES-CD = 0 |
NR |
| Llano et al36 | 7 (50) | M 37 (IQR 28–53) |
CRP: 8 mg/L (<5 to 27) FC: 326 mcg/g (130 to >1000) |
Active luminal disease | Remission: normalization of HBI/Lichtiger | Response: improvement in endoscopic Mayo | NR |
Abbreviations: CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; CRP, C-reactive protein; EIM, extraintestinal manifestations; FC, fecal calprotectin; HBI, Harvey–Bradshaw index; IQR, interquartile range; m, mean; MaRIA, Magnetic Resonance Index of Activity; NR, not reported; PGA, Physician Global Assessment; pMS, partial Mayo score; PRO, patient-reported outcome; R, range; SES-CD, Simple Endoscopic Score for Crohn Disease; UC, ulcerative colitis; wPCDAI, weighted Pediatric Crohn’s Disease Activity Index; ±, standard deviation.
Median (interquartile range) except otherwise specified.
Study was done in pediatric population.
Median or mean was not reported.