TABLE 3.
Randomized controlled trials examining the effect of infliximab in the induction and maintenance of remission in ulcerative colitis
| Reference | Design, 1° outcome period | Group
|
Results | ||
|---|---|---|---|---|---|
| Infliximab regimen | Comparator | Concomitant therapy | |||
| Induction of remission | |||||
| Sands et al, 2001(6) | DB, 2 weeks | 5 mg/kg daily (n=3)
10 mg/kg daily (n=3) 20 mg/kg daily (n=2) |
Placebo (n=3) | Sulfasalazine, mesalazine, antibiotics, azathioprine, 6-MP and antidiarrheal drugs | No significant difference in disease improvement |
| Probert et al, 2003 (4) | DB, 6 weeks | 5 mg/kg daily at weeks 0 and 2 (n=23) | Placebo at weeks 0 and 2 (n=20) | Acetaminophen, 5-ASA, glucocorticoids, azathioprine and 6-MP | No significant difference in disease improvement but there was a trend toward favouring infliximab treatment |
| Armuzzi et al, 2004 (1) | OL, 2 weeks | 5 mg/kg daily at weeks 0, 2 and 6 (n=10) | Intravenous methylprednisolone 0.7 mg/kg to 1mg/kg daily for one week, then tapered (n=10) | Prednisolone | No significant difference between treatment groups |
| Ochsenkuhn et al, 2004 (3) | DB, 13 weeks | 5 mg/kg daily at weeks 0, 2 and 6 (n=6) | Oral prednisolone 1.5 mg/kg daily for two weeks, then tapered (n=7) | Mesalazine, sulfasalazine, antibiotics and antidiarrheal drugs | No significant difference in disease improvement |
| Jarnerot et al, 2005 (2) | DB, 3 months | 4 mg/kg to 5 mg/kg daily (n=24) | Placebo (n=21) | Optional: Oral prednisolone 40 mg daily with 5 mg reduction/week, mesalamine and azathioprine 1.5 mg/kg to 2 mg/kg
Required: Trimethoprim 160 mg and sulfamethoxazole 800 mg daily for 8 weeks |
Infliximab significantly reduced the colectomy rate (RR 0.44, 95% CI 0.22 to 0.87). There were no other significant differences between the two study groups |
| Rutgeerts et al, 2005 (5), (ACT 1) | DB, 8 weeks | 5 mg/kg daily at weeks 0, 2 and 6, then every eight weeks to week 46 (n=121)
10 mg/kg daily at weeks 0, 2 and 6, then every eight weeks to week 46 (n=122) |
Placebo at weeks 0, 2 and 6, then every eight weeks to week 46 (n=121) | Corticosteroids, 5-ASA, azathioprine and 6-MP | Clinical response in 69.4% and 61.5% of patients receiving infliximab at 5 mg/kg or 10 mg/kg daily, respectively versus 37.2% receiving placebo (P<0.001 for both comparisons) |
| Rutgeerts et al, 2005 (5), (ACT 2) | DB, 8 weeks | 5 mg/kg daily at weeks 0, 2 and 6, then every eight weeks to week 22 (n=121)
10 mg/kg daily at weeks 0, 2 and 6, then every eight weeks to week 22 (n=120) |
Placebo at weeks 0, 2 and 6, then every eight weeks to week 22 (n=123) | Corticosteroids, 5-ASA, azathioprine and 6-MP | Clinical response in 64.5% and 69.2% of patients receiving infliximab at 5 mg/kg or 10 mg/kg daily, respectively versus 29.3% receiving placebo (P<0.001 for both comparisons) |
| Maintenance of remission | |||||
| Rutgeerts et al, 2005 (5), (ACT 1) | DB, 54 weeks | 5 mg/kg daily at weeks 0, 2 and 6, then every eight weeks to week 46 (n=121)
10 mg/kg daily at weeks 0, 2 and 6, then every eight weeks to week 46 (n=122) |
Placebo at weeks 0, 2 and 6, then every eight weeks to week 46 (n=121) | Corticosteroids, 5-ASA, azathioprine and 6-MP | Clinical remission in 34.7% and 34.4% of patients receiving infliximab at 5 mg/kg or 10 mg/kg daily, respectively versus 16.5% receiving placebo (P=0.001 for both comparisons) |
| Rutgeerts et al, 2005 (5), (ACT 2) | DB, 30 weeks | 5 mg/kg daily at weeks 0, 2 and 6, then every eight weeks to week 22 (n=121)
10 mg/kg daily at weeks 0, 2 and 6, then every eight weeks to week 22 (n=120) |
Placebo at week 0, 2 and 6, then every eight weeks to week 22 (n=123) | Corticosteroids, 5-ASA, azathioprine and 6-MP | Clinical remission in 25.6% and 35.8% of patients receiving infliximab at 5 mg/kg or 10 mg/kg daily, respectively versus 10.6% receiving placebo (P=0.003 and P<0.001, respectively) |
5-ASA 5-aminosalicylate; 6-MP 6-mercaptopurine; ACT Active Ulcerative Colitis Trial; DB Double-blind; OL Open label