Adalimumab Induction Dose Reduces Hospitalization Risk in Patients With Ulcerative Colitis During the First 8 Weeks of Therapy

Abstract

Analysis of data from 2 double-blind, placebo controlled trials (ULTRA 1 and 2) revealed that adalimumab (ADA) maintenance therapy reduces hospitalization in patients with moderate to severe ulcerative colitis (UC) through Week 52.1 The impact of ADA induction dosing on hospitalization and colectomy has not yet been reported. We assessed the effect of a 160/80/40 mg ADA induction regimen (160 mg at Week 0 and 80 mg at Week 2 followed by adalimumab 40 mg every other week [eow] at Week 4 and Week 6) on the risk of hospitalizations (all-cause, UC-related, and UC- or drug-related) and colectomy during the first 8 weeks of these 2 trials. The pooled dataset included 963 patients (480 ADA, 483 placebo [PBO]). Hospitalization and colectomy events were based on safety reports reviewed by 2 gastroenterologists who were blinded to treatment. Because the exposure was similar between treatment groups, the risk of hospitalizations and colectomies between the groups was compared using Chi-square tests. Significant reductions in the risk of all-cause (40%), UC-related (50%), and UC- or drug-related (47%) hospitalizations were observed in the ADA group compared with PBO (table, P < .05 for all). Although not statistically significant, the relative risk for colectomy was lower in the ADA group compared with PBO (relative risk: 0.8, P < .770). Patients who received 160/80/40 mg ADA induction dosing had a significantly lower risk of all-cause, UC-related, and UC- and drug-related hospitalizations compared with PBO during the first 8 weeks of therapy. The incidence of colectomy was non-significantly lower in patients receiving ADA induction therapy vs. PBO. These data further support a favorable benefit/risk profile of ADA in UC.