Adalimumab: A Review of Its Use in the Treatment of Patients with Ulcerative Colitis

Adalimumab is a fully human, recombinant, monoclonal IgG1 antibody specific for the cytokine tumor necrosis factor-alpha. It is approved for the treatment of patients with inflammatory diseases, including adults with moderately to severely active ulcerative colitis who are refractory to, or intolerant of, corticosteroids and/or immunomodulators. In two well-designed 8- and 52-week clinical trials in patients with moderately to severely active ulcerative colitis despite treatment with corticosteroids and/or immunomodulators, subcutaneous adalimumab (160 mg, week 0; 80 mg, week 2; 40 mg every other week starting at week 4) was more effective than placebo for inducing and maintaining clinical remission. A statistically significant effect size (albeit < 10 %) over placebo for the remission per Mayo score (primary endpoint) was observed with adalimumab at 8 weeks in both trials and at 52 weeks in one trial. Compared with placebo, adalimumab was associated with reductions in hospitalizations and improvements in other secondary endpoints, including clinical response, mucosal healing, corticosteroid-sparing, and health-related quality of life measures. Additionally, an early response to adalimumab was shown to be predictive of long-term efficacy. Adalimumab was generally well tolerated, compared with placebo, during clinical trials in patients with ulcerative colitis; the adverse event profile was similar to that in patients with Crohn's disease or other approved indications. Adalimumab provides a new treatment option for patients with moderately to severely active ulcerative colitis who are refractory to, or intolerant of, corticosteroids and/or immunomodulators.