Adalimumab Therapy Reduces Hospitalization Rates in Patients With Moderate Ulcerative Colitis

Abstract

Introduction: Ulcerative colitis (UC) is a chronic condition associated with hospitalizations, surgery, decreased quality of life, and lost productivity [1]. The purpose of this research was to determine the effect of an adalimumab (ADA) 160/80/40 mg treatment regimen on rate reduction of all-cause, ulcerative colitis (UC)-related, and UC- or drug-related hospitalization among patients with moderate UC in 2 double-blind, placebo-controlled trials (ULTRA 1 and 2). Methods: The pooled data set included 786 patients (395 ADA, 391 placebo [PBO]) with moderate UC. Moderate UC was defined as a baseline Mayo score of 6-10 [2]. Hospitalizations were based on safety reports reviewed by 2 external gastroenterologists [3]. Number of hospitalizations was compared between groups using Poisson regression with time offset. Risk of hospitalizations (Y/N) was compared using person-year (PY)-based incidence rates (IRs), with Z-scores used to assess statistical differences. Results: In patients with moderate UC, significant reductions in the rate of UC-related (51%) and UC- or drug-related (44%) hospitalization events were observed in the ADA group vs PBO (Table, p=.002 and. 008). Although not statistically significant, a 29% reduction in the rate of all-cause hospitalization events was seen with ADA (p=.08). Similarly, significant reductions in the number of moderate patients with UCrelated (46%; p=.015) and UC- or drug-related (39%; p=.037) hospitalization were observed with ADA therapy and a 27% reduction in the number of moderate patients with all-cause hospitalizations was also observed with ADA therapy; this reduction was not statistically significant (p=.148). Conclusion: Among patients with moderate UC, ADA therapy was shown to significantly reduce the rate for UC-related and UC- or drug-related hospitalizations compared with PBO. These results are consistent with previous research in moderate to severe subjects.Table 1: Hospitalizations Rates in ULTRA 1 and 2 Trials Among Patients With Moderate UC