BACKGROUND & AIMS: Subcutaneous golimumab, a fully human monoclonal antibody to 
tumor necrosis factor-α (TNFα), was evaluated as maintenance therapy in TNFα 
antagonist-naive adults with moderate-to-severe active ulcerative colitis, 
despite conventional therapy, who responded to golimumab induction therapy.
METHODS: We performed a phase 3, double-blind trial of patients who completed 
golimumab induction trials (Program of Ulcerative Colitis Research Studies 
Utilizing an Investigational Treatment, eg, PURSUIT). Patients who responded to 
induction therapy with golimumab (n = 464) were assigned randomly to groups 
given placebo or injections of 50 or 100 mg golimumab every 4 weeks through week 
52. Patients who responded to placebo in the induction study continued to 
receive placebo. Nonresponders in the induction study received 100 mg golimumab. 
The primary end point was clinical response maintained through week 54; 
secondary end points included clinical remission and mucosal healing at both 
weeks 30 and 54.
RESULTS: Clinical response was maintained through week 54 in 47.0% of patients 
receiving 50 mg golimumab, 49.7% of patients receiving 100 mg golimumab, and 
31.2% of patients receiving placebo (P = .010 and P < .001, respectively). At 
weeks 30 and 54, a higher percentage of patients who received 100 mg golimumab 
were in clinical remission and had mucosal healing (27.8% and 42.4%) than 
patients given placebo (15.6% and 26.6%; P = .004 and P = .002, respectively) or 
50 mg golimumab (23.2% and 41.7%, respectively). Percentages of serious adverse 
events were 7.7%, 8.4%, and 14.3% among patients given placebo, 50 mg, or 100 mg 
golimumab, respectively; percentages of serious infections were 1.9%, 3.2%, and 
3.2%, respectively. Among all patients given golimumab in the study, 3 died 
(from sepsis, tuberculosis, and cardiac failure, all in patients who received 
100 mg golimumab) and 4 developed active tuberculosis.
CONCLUSIONS: Golimumab (50 mg or 100 mg) maintained clinical response through 
week 54 in patients who responded to induction therapy with golimumab and had 
moderate-to-severe active ulcerative colitis; patients who received 100 mg 
golimumab had clinical remission and mucosal healing at weeks 30 and 54. Safety 
was consistent with that reported for other TNFα antagonists and golimumab in 
other approved indications. ClinicalTrials.gov number: NCT00488631.