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 responses occurred in 141 of the 205 patients (the response rate was 68.8 percent), while clinical remission was reported in 79 of 205 patients (remission rate was 38.5 percent).
Adverse events of any cause occurred in 37 (18 percent) participants. Serious adverse events were experienced by 17 (8 percent) patients, and included ulcerative colitis flare or worsening in 11 patients; accidental overdose in two people; anaphylaxis in one person; constipation in one; rectal fissure in one; and respiratory tract infection in one patient. Due to adverse events, eight patients (4 percent) discontinued treatment.
Patients with a clinical response at the end of the induction phase were suitable to remain for the maintenance phase, which is still ongoing. According to the release, at the end of the induction phase, “patients reported significant improvements in generic quality of life and disease-specific quality of life, including bowel symptoms, emotional function, systemic symptoms and social function.”
Ulcerative colitis is a form of inflammatory bowel disease (IBD) that causes inflammation and ulcers in the colon. Although the condition has no known cause, there is a presumed genetic risk, and it is believed that the disease may be triggered in a susceptible person by environmental factors. Dietary modification may reduce the discomfort caused by the disease.