Table 2.
Clinical efficacy of MMX mesalamine (MES) in induction (8 weeks) of remission in patients with mild to moderate ulcerative colitis
Study | N | Doses | Clinical and endoscopic remission (%) (OR, 95% CI) | Failure rates (%) |
---|---|---|---|---|
Kamm et al39 | 84 | MMX mesalamine 2.4 g daily | 40.5** (2.40; 1.23–4.69) | 21.4*** |
85 | MMX mesalamine 4.8 g daily | 41.2** (2.47; 1.15–5.30) | 20.0*** | |
86 | Asacola 800 mg three times daily | 32.6 (1.70; 0.86–3.36) | 27.9** | |
86 | Placebo | 22.1 | 47.7 | |
Lichtenstein et al56 | 88 | MMX mesalamine 1.2 g twice daily | 34.1*** (3.48; 1.44–8.41) | 28.4*** |
85 | MES 4.8 g daily | 29.2** (2.78; 1.27–6.06) | 24.7*** | |
89 | Placebo | 12.9 | 54.1 | |
Kamm et al58,b | 197 | MMX mesalamine 2.4 g twice daily (No response to MMX mesalamine previously) | 59.5 | _ |
107 | MMX mesalamine 2.4 g twice daily (Placebo previously) | 57 | _ |
Notes:
P < 0.05;
P < 0.01;
P < 0.001 vs placebo.
Included as an internal reference arm; no comparative statistical analyses with the mesalamine treatment arms were reported;
patients who did not achieve the primary endpoint of clinical and endoscopic remission in the 8-week Phase III trials35,51 were eligible for enrolment in the noncomparative extension study (4.8 g MMX mesalamine for 8 weeks).54
Abbreviation: OR, odds ratio.