GO-COLITIS Trial in Ulcerative Colitis Patients Shows Simponi Induces Positive Clinical Response

GO-COLITIS Trial in Ulcerative Colitis Patients Shows Simponi Induces Positive Clinical Response
Janssen Pharmaceutical's Simponi (golimumab) induced a clinical response in more than two-thirds of patients with moderate to severe ulcerative colitis in the induction phase of the GO-COLITIS clinical trial, according to the study “Efficacy and safety of golimumab induction 
for moderate-to-severe ulcerative colitis in 
the United Kingdom: results from the 
GO-COLITIS study (DOP049),” recently presented at the European Crohn’s and Colitis Organization’s (ECCO) Congress in Amsterdam. Simponi “is a human monoclonal antibody that forms high-affinity, stable complexes with both the soluble and transmembrane bioactive forms of human tumor necrosis factor (TNF)-alpha,” as described in a news release. “We are delighted to be able to contribute real-world data to the growing clinical experience with golimumab,” Chris Probert, M.D., of the University of Liverpool, said in the release. “This response rate shows the potential efficacy of golimumab in the management of moderate to severely active ulcerative colitis.” The phase 4, multicenter, open-label, single-arm GO-COLITIS (NCT02092285) clinical trial evaluated the efficacy of Simponi in maintaining a clinical response in 205 participants with moderate to severe ulcerative colitis. The first induction dose of subcutaneous (SC) golimumab 200 mg was administered at Visit 2 (Day 0). The second induction dose of SC golimumab 100 mg was administered two weeks later at Visit 3 (Week 2). Participants at Visit 4 (Week 6) received a maintenance dose of golimumab (50 mg for those who weighed less than 176 pounds, or 100 mg for participants who weighed more than 176 pounds), and every four weeks during the Maintenance Phase for 48 weeks, for a total of 54 weeks of treatment. Clinical response
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