Adalimumab therapy reduces hospitalization and Colectomy rates in patients with Ulcerative Colitis: Data from controlled trials

Abstract

The efficacy and safety of adalimumab (ADA) for the induction and maintenance of clinical remission in patients with moderate to severe ulcerative colitis (UC) was demonstrated in 2 double-blind, placebo-controlled trials (M06-826 and M06-827). We assessed the effect of ADA on the risk reduction of all-cause and UC-related hospitalization and colectomy in these 2 trials. Patients in the 160-/80-mg induction (N=223) and placebo (N=222) arms of M06-826 and patients in the ADA (N=248) and placebo (N=246) arms of M06-827 were combined into a single dataset (N=939). Hospitalization (all-cause and UC-related) and colectomy events were based on serious adverse event reports reviewed by 2 gastroenterologists who were blinded to the treatment groups. The risk of hospitalization was compared between the treatment arms using person-year (PY)-based incidence rates (IRs). Z-scores with confidence intervals were used to determine the statistical difference between treatment groups.1 The number of hospitalizations was compared with Poisson regression with time offset. The table summarizes the hospitalization and colectomy IRs. A 33% reduction in the percentage of patients hospitalized for any reason and a 35% reduction in the number of all-cause hospitalizations were observed with ADA treatment vs. placebo (p<0.05 for both comparisons). When UC-related hospitalizations were compared, the reductions for hospitalization rate (45%) and number of hospitalizations (48%) were both statistically significant. Rates of colectomy were numerically lower in the ADA group compared with the placebo group, representing a 22% reduction. ADA-treated patients had a significantly lower risk for UC-related and all cause hospitalization compared with placebo-treated patients. In addition, a numerically lower colectomy rate in patients receiving ADA therapy vs. placebo was observed. These data support a favorable benefit/risk profile of ADA in UC.