Table 3.
Clinical studies on infliximab-dyyb induction in inflammatory bowel disease.
| Study | Population | Results | Definition of Outcome Response (Remission | Reference |
|---|---|---|---|---|
| Comparison Randomized 8 vs. 12 wks IFX maintenance | CD = 103 | 15 Point decrease in PCDAI Remission: PCDAI ≤10 | 8wks group: 56% 12 wks group: 24% (p = 0.001) | Hyams et al., [122] |
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| ||||
| Comparison Randomized 10 vs. 60 wks IFX maintenance | CD = 40 | Remission: PCDAI <5 | 10 wks group: 83% 60 wks group: 61% | Ruemmele et al., [123] |
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| ||||
| Comparison Randomized 8 vs. 12 wks IFX maintenance | UC = 60 |
Response: Decreased in Mayo score By ≥ 30% and ≥3 points Clinical remission: Mayo score ≤2 with no individual subscore >1 and PUCAI <10 |
8wks group: 38% 12 wks group: 18% (p = 0.146) 54 wks group: 28.6% | Hyams et al., [124] |
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| ||||
| Comparison randomized high dose ADA (40 mg or 20 mg/body weight ≥40kg or 40 kg; n = 95 or Low dose (20 mg or 10 mg/body weight ≥40 kg or 40 kg; n = 95) | Moderate to severe CD = 188 | Response: Decreased in PCDAI ≥15 | High dose: 59% Low dose: 48% (p = 0.073) |
Hyams et al., [125] |
| High dose: 39% Low dose: 28% (p = 0.075) | ||||
| Remission: PCDAI ≤10 | High dose: 42% Low dose: 28% (p = 0.075) | |||
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| Prospective observational | CD = 46 UC = 32 |
Clinical remission rates at week 14 79% (CD), 59% (UC) Significant decrease in CRP, calprotectin | No adverse events reported | Jahnsen et al., [126] |
|
| ||||
| Prospective multicenter | CD = 32 UC = 42 |
Clinical response at week 54 87.5% (CD), 100% (UC) Clinical remission rates at week 54 75% (CD), 50% (UC) | Adverse events in 11% of UC pts | Jung et al., [127] |
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| ||||
| Prospective multicenter, national cohort | CD = 126 UC = 84 | Clinical response at week 14 81.4% (CD), 77% (UC) Clinical remission rates at week 14 53.6% (CD), 58.6% (UC) | Adverse events in 17.1% in all pts | Gecse et al., [128] |
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| ||||
| Switch from RPM to Infleximab-dyyb | Pediatric CD = 32 UC = 7 |
Clinical remission rates 88% (CD), 57% (UC) Decreased in PCDAI, CRP, ESR | No adverse events reported | Sieczkowska et al., [129] |
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| Prospective observational, Cohort switch | CD = 57 UC = 26 |
Clinical response at week 16 Calprotectin | No adverse events reported | Smits et al., [130] |
Abbreviations: IBD: Inflammatory bowel disease. CD: Crohn’s disease. UC: Ulcerative colitis. CRP: C-reactive protein. IFX: Infliximab. ADA: Adalimumab. PCDAI: Pediatric Crohn’s Disease Activity. PUCAI: Pediatric Ulcerative colitis Activity Index. WKS: Weeks. DAI: Disease Activity Index. ESR: Erythrocyte sedimentation rate. HBI: Harvey Bradshaw Index. OCDAL: Pediatric Crohn’s Disease Activity Index.