Table 1.
Clinical trials evaluating the efficacy of anti-tumor necrosis factor α agents in ulcerative colitis patients
| Drug | Trial | Study population | Protocol | Follow-up (wk) | Outcome |
| Infliximab | ACT 1 Rutgeerts et al[5] | 121 | 5 mg/kg iv at 0, 2, 6, | 54 | 69.4% (P < 0.001) clinical response at week 8 |
| and every 8 wk | 45.5% (P < 0.001) clinical response at week 54 | ||||
| 38.8% (P < 0.001) clinical remission at week 8 | |||||
| 34.7% (P = 0.001) clinical remission at week 54 | |||||
| 122 | 10 mg/kg iv at 0, 2, 6, | 54 | 61.5% (P < 0.001) clinical response at week 8 | ||
| and every 8 wk | 44.3% (P < 0.001) clinical response at week 54 | ||||
| 32.0% (P = 0.002) clinical remission at week 8 | |||||
| 34.4% (P = 0.001) clinical remission at week 54 | |||||
| ACT 2 Rutgeerts et al[5] | 121 | 5 mg/kg iv at 0, 2, 6, | 30 | 64.5% (P < 0.001) clinical response at week 8 | |
| and every 8 wk | 47.1% (P < 0.001) clinical response at week 30 | ||||
| 33.9% (P < 0.001) clinical remission at week 8 | |||||
| 25.6% (P = 0.003) clinical remission at week 30 | |||||
| 120 | 10 mg/kg iv at 0, 2, 6, | 30 | 69.2% (P < 0.001) clinical response at week 8 | ||
| and every 8 wk | 60.0% (P < 0.001) clinical response at week 30 | ||||
| 27.5% (P < 0.001) clinical remission at week 8 | |||||
| 35.8% (P < 0.001) clinical remission at week 30 | |||||
| Adalimumab | ULTRA1 Reinisch et al[17] | 130 | 80/40 mg sc | 8 | 51.5% clinical response at week 8 |
| 80 mg at week 0, 40 mg at week 2, 4 and 6 | 10.0% (P = 0.833) clinical remission at week 8 | ||||
| 130 | 160/80 mg sc | 54.6% clinical response at week 8 | |||
| 160 mg at week 0, 80 mg at week 2, 40 mg at week 4 and 6 | 18.5% (P = 0.031) clinical remission at week 8 | ||||
| ULTRA2 Sandborn et al[6] | 248 | 160/80 mg sc | 52 | 16.5% (P = 0.019) clinical remission at week 8 | |
| 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week | 17.3% (P = 0.004) clinical remission at week 52 | ||||
| ULTRA3 Colombel et al[18] | 360 | 40 mg sc every other week | 208 | 63.6% remission per partial Mayo score at week 208 | |
| Golimumab | PURSUIT-SC[20] | 253 | 200/100 mg sc 2 wk apart | 6 | 51.6% (P < 0.0001) clinical response at week 6 |
| 17.8% (P < 0.0001) clinical remission at week 6 | |||||
| 257 | 400/200 mg sc 2 wk apart | 6 | 54.9% (P < 0.0001) clinical response at week 6 | ||
| 17.9% (P < 0.0001) clinical remission at week 6 | |||||
| PURSUIT-M[7] | 151 | 50 mg sc every 4 wk | 54 | 47% (P = 0.010) clinical response at week 54 | |
| 23.2% clinical remission at week 54 | |||||
| 151 | 100 mg sc every 4 wk | 54 | 49.7% (P < 0.001) clinical response at week 54 | ||
| 27.8% (P = 0.004) clinical remission at week 54 |
Clinical response was defined as a decrease from baseline in the total Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the subscore for rectal bleeding of ≥ 1 point or an absolute subscore for rectal bleeding of 0 or 1. Clinical remission was defined as a total Mayo score of ≤ 2 points, with no individual subscore exceeding 1 point. iv: Intravenously; sc: Subcutaneously; ACT: Active Ulcerative Colitis Trials; ULTRA: Ulcerative Colitis Long-term Remission and Maintenance with Adalimumab; PURSUIT-SC: The Program of Ulcerative Colitis Research Studies Utilizing an Investigation Treatment, which was divided into Subcutaneous phases; PURSUIT-M: The Program of Ulcerative Colitis Research Studies Utilizing an Investigation Treatment, which was divided into Maintenance phases.