Results from the GO-COLITIS clinical trial (NCT02092285) confirm that the long-term effects of Janssen Pharmaceutical’s Simponi (golimumab) were maintained in patients with ulcerative colitis (UC), according to MSD, sponsor of the study.
The United Kingdom (UK)-based study confirmed the effectiveness of the drug in inducing and maintaining clinical response during the 66 weeks of treatment since the beginning of the trial.
“We are encouraged by the proportion of patients who maintained clinical response up to and beyond one year, and what this means to patients in terms of disease control,” Chris Probert, MD, lead study investigator, said in a press release. Probert is a professor at the University of Liverpool, UK.
The results were presented by MSD — known as Merck in the U.S. and Canada — at the 25th United European Gastroenterology week, Oct. 27-Nov. 1 in Barcelona, Spain.
GO-COLITIS is designed to evaluate the effectiveness of Simponi in the treatment of ulcerative colitis. Researchers analyzed the induction and maintenance of clinical response in 205 patients. Patients included had moderate-to-severe UC and were not treated with any human tumor necrosis factor (TNF)-alpha type prior to initiation of the clinical trial.
The Phase 4 results presented were a follow-up of the study after assessment at six weeks. After the six weeks, 141 of the 205 patients (68.8%) reacted to once-monthly treatment with Simponi. These 141 patients were followed for the next 60 weeks, designated as the maintenance phase.
At 54 weeks, 52 of the 140 patients (37.1%) had maintained clinical response, and almost one third of the 140 patients (42, 30%) were in clinical remission. In addition, patients reported improvements in quality of life through the IBDQ (Inflammatory Bowel Disease Questionnaire). Adverse events were similar to what was observed during the first six weeks of the study.
At that point, physicians focused on the 52 patients who had maintained clinical response, reviewing if further prolongation (in 21 patients) or discontinuation (in 31) of the treatment with Simponi was necessary. The follow-up period after this decision was 12 more weeks.
At week 66, more than a year after the start of the study and at the 12-week follow-up from the 54-week time-point, all 21 (100%) patients who continued treatment were still in clinical response.
Among the 31 patients whose treatment with Simponi was discontinued, 27 (87%) had maintained clinical response.
According to the researchers, this result indicates that patients who discontinued treatment possibly had a steady loss of response and consequently the effects of the previous treatment were still present. Still this lingering effect, according to the authors, should be evaluated for longer periods of time of at least six months after treatment cessation.
“The GO-COLITIS study results bridge the gap between clinical trials and real-world clinical practice […], with patients experiencing the benefits of better disease control,” added Anita Rose PhD, at MSD.
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