Table 1.
Clinical Trials Evaluating the Efficacy of Different Biologics in Patients with Ulcerative Colitis
| Drug | Study | Study population | Study protocol | Primary endpoint | Efficiency |
|---|---|---|---|---|---|
| Infliximab | ACT 110 | N=364 Moderately to severely active UC (Mayo: 6–12) |
5 mg/kg IV at week 0, 2, and 6 | Clinical response at week 8 | 69.4% (IFX 5 mg/kg) |
| 5 mg/kg IV every 8 weeks after induction until week 46 | Clinical response at week 54 | 45.5% (IFX 5 mg/kg) | |||
| ACT 210 | N=364 Moderately to severely active UC (Mayo: 6–12) |
5 mg/kg IV until week 22 | Clinical response at week 8 | 64.5% (IFX 5 mg/kg) | |
| Clinical response at week 30 | 47.1% (IFX 5 mg/kg) | ||||
| Adalimumab | ULTRA 125 | N=576 Moderately to severely active UC |
160, 80, 40, 40 mg SC every 2 weeks | Clinical remission at week 8 | 18.5% (ADA 160 mg) |
| ULTRA 226 | N=494 Moderately to severely active UC |
40 mg SC every 2 weeks after induction | Clinical remission at week 8 | 16.5% (ADA 160 mg) | |
| Clinical remission at week 52 | 17.3% (ADA 160 mg) | ||||
| Golimumab | PURSUIT-SC28 | N=1,065 Moderately to severely active UC |
200 mg at week 0 then 100 mg SC, at week 2 | Clinical response at week 6 | 51.0% (GLM 100 mg) |
| PURSUIT-Maintenance29 | N=464 Moderately to severely active UC |
100 mg SC every 4 weeks after induction | Clinical response at week 54 | 49.7% (GLM 100 mg) | |
| Vedolizumab | GEMINI 15 | N=895 Moderately to severely active UC (Mayo: 6–12) |
300 mg IV every 4 or 8 weeks/52 weeks | Clinical response at week 6 | 47.1% (VDZ 300 mg at week 0 & 2) |
| Clinical response at week 52 | 44.8% (VDZ 300 mg every 4 weeks) 41.8% (VDZ 300 mg every 8 weeks) |
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| Etrolizumab | Eucalyptus32,33 | N=124 Moderately to severely active UC |
100 mg SC at week 0, 4, and 8 or 420 mg LD then 300 mg at week 2, 4, and 8 | Clinical remission at week 10 | 21% (etrolizumab 100 mg) 10% (etrolizumab 300 mg plus LD) |
| Tofacitinib | Sandborn et al.6 | N=194 Moderately to severely active UC |
15 mg bid for 8 weeks | Clinical response at week 8 | 78% (tofacitinib 15 mg bid) |
ACT, Active Ulcerative Colitis Trial; UC, ulcerative colitis; IFX, Infliximab; IV, intravenous; ULTRA, Ulcerative Colitis Long-Term Remission and Maintenance with Adalimumab; SC, subcutaneous; ADA, adalimumab; PURSUIT-SC, Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment-Subcutaneous; GLM, golimumab; VDZ, vedolizumab; LD, loading dose; bid, twice a day.