BACKGROUND & AIMS: Little is known about the efficacy of golimumab, a fully 
human monoclonal antibody to tumor necrosis factor (TNF) -α, for treatment of 
ulcerative colitis (UC). We evaluated subcutaneous golimumab induction therapy 
in TNF-α antagonist-naïve patients with moderate-to-severe UC despite 
conventional treatment.
METHODS: We integrated double-blind phase 2 dose-finding and phase 3 
dose-confirmation trials in a study of 1064 adults with UC (Mayo score: 6-12; 
endoscopic subscore ≥ 2; 774 patients in phase 3). Patients were randomly 
assigned to groups given golimumab doses of 100 mg and then 50 mg (phase 2 
only), 200 mg and then 100 mg, or 400 mg and then 200 mg, 2 weeks apart. The 
phase 3 primary end point was week-6 clinical response. Secondary end points 
included week-6 clinical remission, mucosal healing, and Inflammatory Bowel 
Disease Questionnaire (IBDQ) score change.
RESULTS: In phase 2, median changes from baseline in the Mayo score were -1.0, 
-3.0, -2.0, and -3.0, in the groups given placebo, 100 mg/50 mg, 200/100 mg, and 
400/200 mg golimumab, respectively. In phase 3, rates of clinical response at 
week 6 were 51.0% and 54.9% among patients given 200 mg/100 mg and 400 mg/200 mg 
golimumab, respectively, vs 30.3% among those given placebo (both, P ≤ .0001). 
Rates of clinical remission and mucosal healing and mean changes in IBDQ scores 
were significantly greater in both golimumab groups vs the placebo group (P ≤ 
.0014, all comparisons). Rates of serious adverse events were 6.1% and 3.0%, and 
rates of serious infection were 1.8% and 0.5%, in the placebo and golimumab 
groups, respectively. One patient in the 400 mg/200 mg group died as a result of 
surgical complications of an ischiorectal abscess.
CONCLUSIONS: Treatment with subcutaneous golimumab induces clinical response, 
remission, and mucosal healing, and increases quality of life in larger 
percentages of patients with active UC than placebo. ClinicalTrials.gov Number: 
NCT00487539.